AS9100c Workbook

Copyright©2009 Lorne Duquette Distributed by as9100store.com 1

The AS9100 Workbook

Building your Aviation, Space & Defense

AS9100C

Quality Management System


Quality Management System Workbook

Workbook cover page Workbook contents page Section 1: The Preparation Phase Section 2: The Development Phase Section 3: The Implementation Phase and Registration Phase Note: 1. This Quality Management System Workbook is suitable for use with the

AS9100C standard for quality management systems. 2. This Quality Management System Workbook is best utilized with the AS

implementation training tools as provided in a series of ppt presentations. Visit www.as9100store.com for the presentation package that matches the

workbook sections.


Quality Management System Workbook

Comments and Instructions:

Congratulations on the management decision to implement the AS9100 Quality management system. This commitment and your participation say a lot about you and show that you are interested in learning, in growing, and in improving your business. This AS9100 Workbook becomes an implementation tool and is intended to make your aviation, space and defense (AS & D) project as organized as possible when executing a set of tasks in the sequence that they are normally required on the journey to AS9100 certification. An important first activity or prerequisite, as the Quality program is launched, is for the Management Representative to become as familiar as possible with the AS9100 Workbook format and content. The Workbook: The workbook is presented in four sections where the AS Tasks and Exercises are introduced, initiated and completed. You will find that your workbook can be used and marked up to develop and detail the information required for each task and exercise. The Workbook Forms: However, since more than one person will be involved in the AS project, the workbook forms that represent the tasks and the exercises are provided in word format for distribution to the staff that will be participating and providing inputs. The Workbook Presentations: The AS9100 workbook is best utilized with AS implementation training tools as provided in a series of ppt presentations that match the workbook sections. The presentations become very effective tools that the Management Representative, as the project manager, can use to keep the momentum moving toward a target registration date.

Good Luck with this important initiative.


Building your AS9100


Section 1: The Preparation Phase


Section 1: The Preparation Phase Responsibility: Management

AS9100 Steering Team Quality Team

1) Management must identify a steering team for the project. It should be made up of managers from the different areas of the organization. The purpose of this team will be to assign resources and responsibilities for the project as well as providing leadership for the project. Include top management on the team. 2) Once the steering team has been identified, the team can work together to complete the assigned tasks for the workbook sections. The sections help you prepare for the project and put together the project plan and timeline. Task 1: Management Describe your company Task 2: Management Choose your Management System Task 3: Management Obtain the latest AS9100 standard Task 4: Management Select the Management Representative and the AS9100 Steering Team Task 5: AS Steering Team Prepare an Organizational Chart Task 6: AS Steering Team Establish the Quality Team Task 7: Quality Team Conduct First Team Meeting Task 8: AS Steering Team Formulate the Quality Policy / Objectives Task 9: AS Steering Team State the scope of the QMS Task 10: Quality Team / Identify the interrelated requirements* AS Steering Team Note: *Interrelated requirements identified with Task 10 take into consideration the applicable requirements associated with customer, regulatory, statutory, legal and other requirements along with special requirements, critical items and key characteristics.


Task 1 The Journey to AS9100 DESCRIPTION OF YOUR COMPANY 1. Name of your organization: _______________________________________________________ Name of Owner / Managing Director / the Boss: _______________________________________________________ Date / Year established: ___________ Total number of employees: _________ 2. What Aviation, Space & Defense (AS & D) activities are you primarily involved in? __ Design and Development, __ Production, __ Installation, __ Maintenance, __ Stocklist Distribution. 3. Do you describe your company, your products in a brochure? _____ Yes ____ No 4. If No .. State what your company does!! ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _____________________________________________________________ Prepared by : ____________________________ Date: _________


Task 2 DECIDE on the MANAGEMENT SYSTEM for your COMPANY: _________________________________________________________________ Options for Management Systems:

• AS9100 - Quality Management System – Design, development, production and installation.

• AS9110 - Quality Management System – Maintenance activities.

• AS9120 - Quality Management System – Stocklist Distribution.

• ISO 9001:2008 – Quality Management System

In my organization, the management system best suited for our AS & D activities is:

AS9100 Rev C for QUALITY MANAGEMENT SYSTEMS

Comments: -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________

Task 3 Obtain the latest AS9100 standard The requirements sections of the AS9100C document is published in a total of 22 pages and provides requirements for the five main clauses 4, 5, 6, 7, & 8. This SAE document is required to be available for your review and study. Department Heads … Check your files, records, library, etc. to determine if a copy of the AS9100C Publication is available at your company.


If not .. Obtain a copy ASAP Visit www.as9100store.com/BuyStandards.aspx to buy a copy of the standard.

• A series of training exercises will be completed to help you become more familiar with the requirements.

• The availability of the standard is a prerequisite for the completion of Task

15 in Workbook Section 2. Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________


Task 4 Appoint the Management Representative and the AS9100 Steering Team The paragraph 5.5.2 of AS9100 outlines the requirements for a Management representative and is paraphrased below:

A Management representative needs to be selected from the management group and appointed to coordinate the development and implementation of the QMS. The representative needs to be knowledgeable of quality assurance principles and be familiar with the company’s operations, processes, customer and regulatory requirements. The management representative must have the organizational freedom and unrestricted access to top management to resolve quality management issues.

========================================================

AS9100 –MANAGEMENT REPRESENTATIVE At _____________________________________ (your company), The person best suited to carry out the responsibilities of Management Representative is:



Task 4 (cont’d) Select the AS9100 Steering Team The AS Steering Team will be made up of management personnel that represent the various areas of the organization. The team will meet on a regular basis throughout the implementation project and coordinate the project activities, provide resources, assign responsibilities and review and approve the AS9100 documents. The management representative is one of the members of the steering team.

========================================================

AS9100 – Steering Team The members of the AS9100 Steering Team are: Management representative Name Title

Name Title

Name Title

Name Title

Name Title

Name Title

Name Title

Name Title

Comments: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ See also Quality Team selection at Task 6 Prepared by; __________________________ Date: ______________


Task 5 Prepare the Organization Chart for your company

ORGANIZATION CHART for ______________________

Comments: …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….………… Prepared by; __________________________ Date: ______________

PRESIDENT - OWNER

QUALITY

MANAGEMENT REPRESENTATIVE


Task 6 Appoint the Quality Team

@ ________________________________________________________ (your company).

From Task 4 The Quality Management Representative is:

__________________________________________________________________

Note: In small and medium size enterprises (SMEs), one group (the AS Team) can effectively function as both the AS Steering Committee (Task 4) and the Quality Team (Task 6). For this Task 6 Appoint the Quality Team A quality team needs to be selected and appointed, • Multi-disciplinary teams to establish, implement, maintain and regularly review

the QMS. The Quality team shall have sufficient knowledge and experience with regard to the organization’s products and process within the scope of the quality management system.

IN SUPPORT OF THE QMS MANAGEMENT REPRESENTATIVE, THE MEMBERS OF THE QUALITY TEAM ARE:

TITLE

• Quality management representative

• Personnel Manager

• Technical support manager

•

•

•

NAME

Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________


Task 7 Conduct the first Quality Team meeting At ____________________________________________ (my company) .

The 1st Quality team meeting will be held on ________________ (date)

*The Quality management representative will chair / lead the meeting

* Provide agenda for meeting. So that the identified TASKS can become Agenda Items for the weekly Team Meetings and can be followed up until completed. *Issue notes to summarize discussions & decisions.

* Schedule the next Quality team meeting.



Task 8 Formulate the Quality Policy

The Quality Policy for ____________________________ (your company)

____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Example below:

QUALITY POLICY With integrity in the workplace, dedicated employees, and innovative services, our QUALITY POLICY is to satisfy our customers with a full range of your AS & D activities / products / services that meet the needs and expectations of international and domestic customers.

******

Prepared by: ___________________________________ Date: ______________


Task 8 (cont’d)

Define the objectives for: ___________________________ (COMPANY)

The main objectives for years _______, ________, ________, _______. Objectives

• ………………………………………………………………………………………………………………………………………………………………………………………………

• ………………………………………………………………………………………………………………………………………………………………………………………………

The principal plan of action:

We intend to achieve this through: 1. 2.

3. The first Quality Objective is to establish and document good manufacturing practices, systems and procedures leading to qualification for registration to the AS9100 quality system requirements.

4. The next quality objective is identified as:

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

5. …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

6. ....................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................

Prepared by: __________________________________ Date: _____________


Task 9 State the Scope of the QMS 3. State what your company does !!

To determine the SCOPE of the Quality Management System .. What product lines will impact the QMS? .. List your product / categories below: ___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ For example: The scope of the Quality Management System includes the design and development and manufacture of tires used in the landing gears of aircrafts. The scope of the Quality Management System includes the assembly and installation of seating systems used in commercial passenger aircrafts. The scope of the Quality Management System includes the maintenance activities required for the private aircrafts operating from the regional airports. The scope of the Quality Management System includes the distribution activities associated with the supply of ‘stocklist’ items for the general aerospace industry. Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________


Task 10 Identify the interrelated requirements A. Define your Products For this task, make use of the preliminary list that was started at Task 1 and expanded at Task 9 to fine tune your product or service (product) list. The customer contract review procedure established under the Customer Related Processes becomes a logical point in this continuum. Go to your customer input data (contracts, drawings, specifications, etc.) to define and identify the products or services. AS & D products and services are listed, defined and classified in a variety of sources available through the Federal Aviation Administration (FAA), www.faa.gov

Prepare a listing of the products or services that make up your product line(s).

Change Configuration Name of Product or Service

Identification Part Number Chg Let Date Class

………………..……

………………………

……..

……..

……..

……………………..

…………………….…

……..

……..

……..

……………….……

………………….……

……..

……..

……..

……………….……

………………………

……..

……..

……..

…………………..…

…………………….…

……….

……..

……..

Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by: _________________________ Date: _______________


B. Classify your products Go to your customer input data (contracts, drawings, specifications, etc.) and record the change letter / number and the date (contracts, drawings, specifications, etc.) for each product or service. For configuration management purposes, determine the classification for your AS & D products or services. As a prerequisite to configuration control, it is important to understand the classes of change and the implications of these changes.

Class I changes affect the fit, form or function of an item. These are changes that affect the specifications, weight, interchangeability, interfacing, reliability, safety, schedule, cost, etc. of an item.

Class II changes are changes to correct documentation or changes to hardware not otherwise defined as a Class I change.

Note that a procedure MP-713c for configuration management is available in our AS9100C QMS Documentation package.

Visit http://www.as9100store.com/as9100-procedures.aspx for more information.

Change Configuration Name of Product or

Service

Identification Part Number

Change Letter/Number

Date

Class I, II

…………….

…………………

……..

……..

……..

…………….

…………………

……..

……..

……..

……………

……………….

……..

……..

……..

…………….

…………………

……..

……..

……..

……………

…………………

……….

……..

……..

Comments: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prepared by: _________________________ Date: _______________


C. Identify Other Interrelated Requirements Research is needed to accomplish this important task. Go to the Terms and Definitions section 3 of the AS9100 publication to become familiar with other interrelated requirements that apply to your products. For example, the standard defines risk, special requirements, critical items and key characteristics as three interrelated product requirements based on the level of control necessary to ensure safety and effectiveness. Risk: Risk can be described as an undesirable situation or condition that is likely to happen with the potential of having a negative impact. The management of risks is further addressed in this AS Workbook at Task 15 with Exercise G. Special requirements: The requirements that are identified by the customer or that are determined by your company to have high risks of being achieved are required to be included in the risk management process. Factors to consider include the complexity of product or process, any past experience, the process or product maturity and other performance requirements identified by the customer or determined by your company to be at the limit of your technical or process capabilities. Special requirements can require the identification of critical items. Go to your customer input data (contracts, drawings, specifications, etc.) to define and identify interrelated requirements. For your products or services, indicate the YES or NO status of interrelated requirements relative to special requirements.

Change Configuration

Other Interrelated Requirements Name of

Product or

Service

Part

# Chg Let

Date Class I or II

Special Requirements

Critical Items

Key

Characteristics

………

……

……

……

…….

………………….

………

………………

………

……

……

……

…….

……….

………

………………

………

……

……

……

…….

……….

………

………………

………

……

……

……

…….

……….

………

………………

Comments: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prepared by: _________________________ Date: _______________


Critical Items: Critical items include functions, parts, characteristics, processes that have significant effect on product realization and use of the product such as safety, performance, form, fit, function, etc, that require specific actions to ensure that they are adequately managed. Critical items include safety critical items, fracture critical items and key characteristics.

Critical items and special requirements can be identified when reviewing the requirements related to the product.

Go to your customer input data (contracts, drawings, specifications, etc.) to define and identify interrelated requirements. For your products or services, indicate the YES or NO status of interrelated requirements relative to critical items. Design output can include the identification of critical items that require specific actions to ensure that they are managed adequately.

Note that a procedure EP-730c for design and development is available in our AS9100C QMS Documentation package.


Change

Configuration Other Interrelated Requirements Name

of Product

or Service

Part

# Chg Let

Date Class I or II


Critical Items Key Character

istics

………

……

……

……

…….

……………

………

………

………

……

……

……

…….

……….

………

………

………

……

……

……

…….

……….

………

………

………

……

……

……

…….

……….

………

………



Key Characteristics: A key characteristic is described as an attribute or feature where variation has a significant effect on product fit, form, function, performance, service life, or manufacturability that requires particular attention for the purpose of controlling variation. Go to your customer input data (contracts, drawings, specifications, etc.) to define and identify interrelated requirements. For your products or services, indicate the YES or NO status of interrelated requirements relative to key characteristics. Design output can include the identification of critical items that require specific actions to ensure that they are managed adequately. Some critical items can further be classified as key characteristics because their variation needs to be controlled.

Note that a procedure EP-731c for key characteristics is available in our AS9100C QMS Documentation package.



Other Interrelated Requirements Name of

Product or

Service

Part

# Chg Let

Date Class I or II


Critical Items

Key Characteristics

………

……

……

……

…….

…………….

…………

…………………………….

………

……

……

……

…….

……….

…………

………………….

………

……

……

……

…….

……….

…………

………………….

………

……

……

……

…….

……….

…………

………………….



D. Identify the applicable regulations With your products defined, classified, and interrelated requirements identified, you are in a position to determine the regulations that apply Research is needed to accomplish this important task. The customer contract review procedure established under the Customer Related Processes becomes a logical start point. Go to your customer input data (contracts, drawings, specifications, etc.) to identify any regulations that are specifically required. For your products or services, record the applicable identification and date for the regulations. Regulations governing AS & D products are available through the Federal Aviation Administration (FAA), www.faa.gov . Prepare a formal listing of the regulations that apply to your products or services.


Other Interrelated Requirements

Name of

Product or

Service

Part #

Chg Let

Date Class Special Req’ts

Critical Items

Key Characteristics

Applicable

Regulations

Latest Date

………

……

…..

……

…….

………

……

………

…………………. ………………….

……….. ………..

………

……

…..

……

…….

………

……

………

………………….… …………………….

……….. ………..

………

……

…..

……

…….

………

……

………

………………….… …………………….

……….. ………..

………

……

…..

……

…….

………

……

………

………………….…

………..

Other significant requirements can be identified as part of this task. For example, the following standards are significant other requirements: AS9100C ………….. dated 2009-11 ISO 9001:2008 …… dated 2008-11-15 Standards are available from sources such as www.iso.org and www.techstreet.com Comments: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prepared by: _________________________ Date: _______________


Task 10 Identify the applicable interrelated requirements Maintain a registry to summarize the interrelated requirements that are relevant to your organization.

Change Configuration Other Interrelated Requirements Name of Product or

Service

Identification Part

Number Chg Let

Date Class Special Req’ts

Critical Items

Key Characteristics

Applicable

Regulations

Latest Date

…………………

……………..

……..

……..

……..

………..

…………

……………….…

………………….… ……………………. ……………………..

……….. ……….. ………..

…………………

………………

……..

……..

……..

……….

…………

………………….

………………….… ……………………. …………………….

……….. ……….. ………..

…………………

………………

……..

……..

……..

……….

…………

………………….

………………….… ……………………. …………………….

……….. ……….. ………..

…………………

………………

……..

……..

……..

……….

…………

………………….

………………….… …………………….

……….. ………..

…………………

………………

……….

……..

……..

………..

………..

…………………

……………………… ………………………

…………. ………….

Compiled by: Quality management representative: ________________________ Date: _________ Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------




Section 2: The Development Phase


Section 2: The Development Phase Responsibility: Management

AS9100 Steering Team Quality Team

At Task 4 in Section 1, management identified a steering team for the project. It should be made up of managers from the different areas of the organization. The purpose of this team will be to assign resources and responsibilities for the project as well as providing leadership for the project. Include top management on the team. Once the steering team has been identified, the team can work together to complete the assigned tasks for the workbook sections. The sections help you prepare for the project and put together the project plan and timeline.

Task 11 Quality Team Identify / Describe your processes / Prepare the process flow diagrams Task 12 AS Steering Team Provide Communication Tools Task 13: Quality Team Conduct a Preliminary Assessment –checklist Task 14: AS Steering Team Assign Improvement Actions for QMS Task 15: AS Steering Team Provide AS9100 training with Exercises A--F Conduct clause 7 risk analysis with Exercise G Task 16: AS Steering Team Manage the Implementation Project Task 17: AS Steering Team Complete Project Timing Chart Task 18: AS Steering Team Collect Existing Documents Task 19: AS Steering Team Perform financial study of costs and benefits Task 20: AS Steering Team Reconfirm the AS9100 Decision Task 21: AS Steering Team Promote and practice teamwork


Task 11a Identify your Processes

Most Businesses have similar basic processes that are controlled and incorporated in a QMS. They are listed as:

� Public relations, Sales and order management, � Purchasing and material control, � Production and shipping, � Management and administration, � Review and improvement.

Review the list and determine if your organization has the same, or similar, or different functions. Add your comments in areas below:

� Public relations, Sales and order management, ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

� Purchasing and material control, ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

� Production and shipping, ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

� Management and administration, ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

� Review and improvement. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Make use of Task 11b Process description worksheet to further detail your individual activities. Prepared by _________________________ Date _____________


Process Description Worksheets - Task 11b For the processes identified at Task 11, review the process description examples below (forms #401-1 to 5) and adjust your descriptions and activities that apply to your company.

Process Identified @ Task 11a F- 401-1 Public relations, Sales and order management, _________________________ An example of the process description is provided below:

7

CC

UU

SS

TT

OO

MM

EE

RR

Requirements

CC

UU

SS

TT

OO

MM

EE

RR

Satisfaction

Quality Management System - Procedures, Instructions, and Records

Activities include:

Preparing quotations / proposals

and service promotions;

Selling and accepting orders

from customers;

Entering orders into the system for production and delivery;

Providing customer support services;

Communicating with customers to

determine what they need

and their level of satisfaction;

Monitoring competition for new service / product and

market intelligence.

Process Description

1. Public relations, sales and order management

Your process is described as follows: ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prepared by: ______________________________ Date: _______________


Process Identified @ Task 11a F- 401-2 Purchasing and material control, ___________________________

An example of the process description is provided below:

9

CC

UU

SS

TT

OO

MM

EE

RR

Requirements

CC

UU

SS

TT

OO

MM

EE

RR

Satisfaction

Process Description

2. Purchasing and material control

Activities include:

Determining and maintaining inventory levels

for service delivery supplies and materials;

Preparing and issuing purchase orders to suppliers;

Monitoring supplier performance and product offerings;

Evaluating and selecting suppliers;

Approving supplier invoices;

Ensuring suppliers provide the best price consistent with quality


Your process is described as follows: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by: ______________________________ Date: _______________


Process Identified @ Task 11a F- 401-3 Production and shipping, ___________________________ An example of the process description is provided below:

10

CC

UU

SS

TT

OO

MM

EE

RR

Requirements

CC

UU

SS

TT

OO

MM

EE

RR

Satisfaction

Process Description3. Development, Production and Service Delivery

Activities include:

Managing work in process;

Providing work instructions and

related information to development staff;

Maintaining development / production equipment;

Planning and scheduling work in process;

Supervising and training staff;

Planning and controlling inspection

and quality control activities;

Delivering service products;

Providing customer service


Your process is described as follows: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by: ______________________________ Date: _______________


Process Identified @ Task 11a F- 401-4 Management and administration, ___________________________ An example of the process description is provided below:

11

CC

UU

SS

TT

OO

MM

EE

RR

Requirements

CC

UU

SS

TT

OO

MM

EE

RR

Satisfaction

Process Description4. Management and administration

Activities include:

Planning and controlling the operation;

Establishing budgets and goals for each process and activity;

Developing new services / products or adopting existing services / products

for new applications;

Hiring, training and managing employees;

Maintaining relationships with key customers and suppliers;

Maintaining relationships with stakeholders and directors


Your process is described as follows: -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by: ______________________________ Date: _______________


Process Identified @ Task 11a F- 401-5 Review and improvement. ___________________________ An example of the process description is provided below:

12

CC

UU

SS

TT

OO

MM

EE

RR

Requirements

CC

UU

SS

TT

OO

MM

EE

RR

Satisfaction

Process Description 5- Review and improvement

Activities include:

Perform management reviews;

Conduct internal quality audits;

Control nonconformities;

Analyse data for continual improvement;

Analyse statistical techniques;

Implement corrective and preventive actions


Your process is described as follows: -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by _______________________________ Date ______________


Task 11c Draw the Process Flow Diagram(s) for your production operations and departmental functions.

Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________

Purchase

Receive

Storage


Task 12 Provide Communication Tools To reduce the anxiety of staff, information relative to the QMS needs to be made readily available. By __________________, (date)

Consider a centrally located AS BULLETIN BOARD where relevant news and updates can be posted.

Identify OTHER COMMUNICATIONS methods you may want to consider: …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Do Not forget to formally “Announce the Launch of the Quality program”

Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________

AS9100 Quality Management System - Bulletin Board


Task 13 Conduct a QMS Preliminary Assessment Use the “QMS Assessment Checklist” This should be completed as early as possible. The assessment is scheduled for: ________________, _______________ (date) Instructions: 1. This checklist is based on the requirements specified in the 5 main clauses of AS9100C

standard for “Quality Management Systems” and can be used by auditors / inspectors to conduct preliminary assessments of Quality Management Systems in Aviation, Space and Defense (AS & D) organizations.

2. This checklist is used to identify the many good activities that are currently “In Control” and to highlight the areas that “Need Attention”.

3. The box beside each item can be checked to indicate that a "situation is in control," or one that “needs further attention”, or one that is “not applicable”. The space at the end of each topic or the back of the page can be used to make comments and provide details.

4. After completing the assessment, the completed document can serve as a tool for the

responsible personnel to plan and implement improvement / corrective actions.

Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- A more comprehensive assessment can be completed with the use of a ‘Gap-Analysis’ checklist. Visit as9100store.com for further information. Prepared by; __________________________ Date: ______________


Preliminary Assessment - Questionnaire / Checklist Company Name:_________________________________ Date Started: __________________ Instructions: 1. This checklist is based on the requirements specified in the 5 main clauses ofAS9100C standard

for “Quality Management Systems” and can be used by auditors / inspectors to conduct preliminary assessments of Quality Management Systems in Aviation, Space and Defense organizations.

2. This checklist is used to identify the many good activities that are currently “In Control” and to highlight the areas that “Need Attention”.

3. The box beside each item can be checked to indicate that a "situation is in control," or one that “needs further attention”, or one that is “not applicable”. The space at the end of each topic or the back of the page can be used to make comments and provide details.

4. After completing the assessment, the completed document can serve as a tool for the responsible

personnel to plan and implement improvement / corrective actions.

4-QUALITY MANAGEMENT SYSTEM OK – In Control

Needs Attention

Within your existing system, are your activities controlled through some type of quality control / inspection system that provides you with the confidence that the customer will be satisfied?

…Can you provide some examples of improvement in the activities of the company?

…If you ‘out-source’ / sub-contract processes, are these processes identified & controlled?

…When problems are identified, are actions taken to correct the problems?

Does your quality management system address customer and applicable statutory and regulatory requirements?

Does your organization maintain a record / registry of interrelated requirements (customer, regulatory, statutory, legal and other requirements)?

Does your organization have a quality manual?

… Does your organization ensure that personnel have access to and are aware of relevant QMS documentation and changes?

Does your organization have a documented procedure regarding the control of documents?


Does your organization have a documented procedure for the control of records?

… Does the procedure define the method for controlling records that are created by and/or retained by suppliers?

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

5-MANAGEMENT RESPONSIBILITY

Has top management demonstrated commitment to both the development and implementation of the QMS?

Does top management ensure that product conformity and on-time delivery performance are measured and that appropriate actions are taken if planned results are not or will not be achieved?

Does your organization have a process in place to identify your customer requirements?

Does your organization have a process in place to identify the regulatory requirements?

Has management formulated and approved a Quality Policy? …Is the quality policy communicated and understood at all levels of the organization?

Has management established the quality objectives for the organization?

Do you have a method / process for the planning of the QMS?

Are responsibilities, authorities and their interrelation defined and communicated within your organization?

Has top management appointed a management representative to deal with matters concerning the QMS?

… Does the management representative have the organizational freedom and unrestricted access to top management to resolve quality management issues?

Has a communication process been established within your company?

Are management reviews of the quality system conducted by top management? …Does management review include inputs relative to the improvement of the QMS? … Does the output from management review include the decisions and actions related to improvement of the effectiveness of the QMS?


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

6 RESOURCE MANAGEMENT Has your organization provided the resources needed to Implement and

maintain the effectiveness of the QMS?

…Have you provided the resources needed to make sure that the customers are satisfied by consistently meeting their requirements?

…Have you provided the resources needed to make sure that the regulatory requirements are consistently met?

People represent a very valuable asset for companies. How many people do you have in your organization? – We have ___ PEOPLE

…Are personnel with assigned responsibilities competent on the basis of appropriate education, training, skills, and experience?

…Has your organization determined the competence required for personnel performing work affecting product quality?

…Has your organization provided QMS / AS training to the personnel?

…Are records of competence, awareness and training maintained?

Has your organization provided the facilities / infrastructure needed to meet service / product requirements?

…Do you have a maintenance program for the equipment?

Has your organization determined the work environment needed to achieve conformity to service / product requirements?

…Do you have a program to maintain an environment conducive to the development and delivery of quality services and products?

.. Does the program include good practices and requirements relative to health, cleanliness, protective clothing, etc?

…Do you have a maintenance program for the equipment?

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


7 PRODUCT / SERVICE REALIZATION Does your organization plan and develop in sufficient details the processes

needed to realize the services / products / documents required for the services?

Does the planning of quality objectives and of product requirements consider aspects such as product and personal safety, embedded software, etc?

…Is the output of the planning process in a form suitable for your method of operation?

… Is the product realization addressed throughout project management techniques?

… Is the management of risks addressed throughout the product realization activities?

… Is configuration management used to address and support, as applicable, the products from concept to disposal?

… Is there a process to plan and control the temporary or permanent transfer of work from one location to another?

Do you determine customer requirements, service / product requirements (stated or implied) including any ‘Special Requirements’ along with statutory & regulatory requirements related to the services / products?

…Does your organization review customer requirements prior to the commitment to supply the service / product?

…Has a process of review (submission of a tender, acceptance of contract or order) been established?

…When the customer requirements are changed, how are the relevant documents amended and the personnel made aware of the changes?

…Do you have arrangements in place for communication with customers regarding their requirements?

Does your organization plan and control the design and development of products or services?

… Are the design and development activities divided into distinct activities where tasks, resources, responsibilities, etc are defined?

... Does design and development planning consider the ability to produce, inspect, test and maintain the product?

…Are inputs relating to product/service requirements determined?

…Are the outputs of design and development recorded in a form (drawings, parts lists, specifications, etc) that enables verification against the inputs?


…Are the outputs approved prior to release?

… Do the outputs specify, as applicable, any critical items, including key characteristics with the specific action to be taken for these?

…Are systematic reviews of design and development conducted at suitable stages of the design process?

… Do design reviews include the authority to progress to the next stage?

…Is design and development verification performed to ensure the outputs meet the design and development inputs?

…Is design and development validation performed to ensure the outputs meet the design and development inputs?

… Are the design and development verification and validation testing planned, controlled, reviewed and documented?

…Are design/development changes controlled in accordance with the configuration management process?

…Are design/development changes verified, validated and approved prior to implementation?

How does your organization ensure that purchased products /supplies conform to specified purchase requirements?

…Do you evaluate and select suppliers based on their ability to supply products or services – for example, do you make use of information from external sources such as ISO registrars, government agency approvals, etc?

… Do you maintain a supplier register that indicates the approval status?

… Do the purchasing information/documents describe the product purchased?

…Do you confirm the adequacy of specified purchase requirements prior to their communication to the supplier?

…Have you established and implemented inspection or other activities to confirm that purchased product meets specified requirements?

How does your organization ensure that out-sourced / sub-contracted services conform to specified requirements?

… Do you ensure that your organization and all suppliers use customer approved sources for Special Processes?

… Do you maintain a Register of Delegation when your organization delegates verification activities to suppliers?


How does your organization plan and control production and service operations? .. Description of product characteristics, procedures, instructions, suitable equipment, measuring devices, release, delivery, post-delivery service, labelling and packaging.

… Does the planning for control of production and service provision consider the processes to manage critical items including process controls where key characteristics have been identified?

… Is first article inspection of a representative item used to verify the production process and repeated when significant changes occur?

… Are the personnel authorized to approve changes to production processes identified?

… Are the production equipment, tools and software programs used to automate and control/monitor product realization processes validated prior to release?

… Does your post-delivery support include items such as the collection and analysis of in-service data, controls required for off-site work done at the customer’s location?

Does your organization have any ‘special’ processes for production or service where the output cannot be verified by monitoring or measurement? …How do you validate these processes?

How does your organization identify the product throughout production? – Maintenance of configuration, batch number, name of product, date of manufacture, etc

…Is the product (good or bad) status maintained throughout production, storage, installation and servicing activities to ensure that only acceptable products are released?

…Do you have a system for the traceability of product?

... Is the identification required for traceability purposes such that it can be maintained throughout the life of the product?

… Do you have the ability to trace products manufactured from the same batch of raw material, or from the same manufacturing batch, to the delivery destination or to scrap?

How does your organization maintain the customer (intellectual) property while it is under your control?

Does your organization protect / preserve the conformity of the products / documents during internal processing and delivery?


…Does preservation include identification, handling, packaging, storage and protection of the product and the constituent parts?

…As applicable to product specification and statutory & regulatory requirements, does preservation include provisions for cleaning, prevention, detection and removal of foreign objects, special handling for sensitive and hazardous materials, marking, labelling for safety warnings, shelf life control, and stock rotation?

Have you identified the monitoring methods that are required for the service preparation and service delivery activities?

Have you identified both the measurements to be made and the measuring and monitoring devices needed in order to assure the product (service documents) meets requirements?

… Does your organization maintain a register of the monitoring and measurement equipment

…Is the measuring equipment calibrated at specified intervals against standards traceable to international or national standards?

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………..

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT Has your organization planned and implemented the monitoring,

measurement, analysis and improvement processes for the QMS?

Do you make use of statistical techniques as a measurement method?

Does your organization receive feedback and monitor information on customer perception regarding customer satisfaction?

… Has your organization developed and implemented plans for customer satisfaction improvements that address customer concerns?

Is there a documented procedure for internal QUALITY audits?

…Are internal audits conducted at planned intervals to determine if the QMS is effectively implemented and maintained? …Are auditors selected to ensure the audits and auditors are objective and impartial in the audit process?

Does your organization have methods for monitoring of the QMS processes? …When the results are not achieved, are corrective actions taken to confirm conformity of the product?

Does your organization monitor and measure the characteristics of the product to verify product requirements are met?


… When critical items, including key characteristics are identified, are they controlled and monitored in accordance with the established processes?

... When sampling plans are used to accept product, are the plans justified on the basis of recognized statistical principles and appropriate to the capability of the process and the criticality of the product?

... In the event that product is released prior to the completion of all inspection and tests, can the product be recalled for replacement should subsequent results show that requirements are not met?

…Do you have records available indicating the person authorizing release of product as it is processed through the operations?

… Do you ensure that the documents required to accompany the products are present at delivery?

Is there a documented procedure for control of non conformity? …How does your organization ensure that product which does not conform to requirements is identified & controlled to prevent unintended / accidental use? …Are the controls and responsibilities and authorities for nonconforming product defined in a documented procedure? …Are records maintained for nonconformities, actions taken and (if applicable) approvals obtained for authority to use as is (deviations / concessions)? … Does your organization recognize that the dispositions of use-as-is or repair can not be used unless specifically authorized by the customer if the nonconformity results in a departure from the contractual requirements? … Does your organization recognize that the dispositions of use-as-is or repair can only be used after approval by an authorized representative responsible for the design? … Does the disposition of scrap product include permanent marking and the positive control until it is rendered physically unusable? … Do you document the instructions for the rework process when products need to be reworked? … Do the instructions include the same authorization and approval as the original instructions?

Does your organization collect and analyze existing data to demonstrate the suitability and effectiveness of the QMS?

Does your organization collect and analyze data to identify and implement the changes needed to ensure and maintain a suitable and effective QMS?


… Are continual improvement opportunities identified from lessons learned, problem resolutions and benchmarking of best practices?

Are corrective actions taken to eliminate the causes of nonconformities to prevent reoccurrence?

… Does your organization include in the corrective action process: - Down flowing of corrections at the supplier level when appropriate? - Taking specific action when timely and/or effective results are not achieved? - Determining if additional nonconformities exist based on the causes found and taking further actions?

…Is there a documented procedure for corrective action? Has your organization established a method / procedure to eliminate the cause of potential nonconformities? … Is there a documented procedure for preventive action?

Summary: ___ Short Term Improvement Actions – within 1 month ___ Mid-Term Improvement Actions – within 2 to 6 months ___ Long Term Improvement Actions – within 7 to 12 months

SUMMARY OF FINDINGS Clause 4-QUALITY MANAGEMENT SYSTEM Clause 5-MANAGEMENT RESPONSIBILITY Clause 6 RESOURCE MANAGEMENT Clause 7 PRODUCT REALIZATION Clause 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

TOTAL SITUATIONS

“IN CONTROL“

TOTAL SITUATIONS THAT “NEED

ATTENTION”

________ OK FROM ________ TOTAL SITUATIONS ASSESSED

_______ % SITUATIONS IN CONTROL ON DATE OF: ________________


Task 14 Implement the IMPROVEMENT ACTIONS needed to increase your Quality Capabilities. The production location was visited and a preliminary inspection conducted.

• Used a checklist and asked some …. Approximately 100 questions

• Obtained ____ favourable answers and identified ____ areas that Need Attention.

The ___ areas that NEED ATTENTION are reviewed & improvement actions identified as:

• Short Term, where improvements can be implemented within 1 month.

• Medium Term, where improvements can be implemented within 2 to 6 months.

• Long Term, where improvements can be implemented within 7 to 12 months. SHORT TERM IMPROVEMENT ACTIONS – To be implemented within 1 month # Improvement Action Assigned to Promise

Date Actual Date

Comments

1 2 3 4

MEDIUM TERM IMPROVEMENT ACTIONS – To be implemented within 2 to 6 months # Improvement Action Assigned to Promise

Date Actual Date

Comments

1 2 3 4

LONG TERM IMPROVEMENT ACTIONS - To be implemented within 6 to 12 months # Improvement Action Assigned to Promise

Date Actual Date

Comments

1 2 3 4

Comments: --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Prepared by: __________________________ Date: ______________


Task 15 Provide training – Review Clauses 4 thru 8 of AS9100C

But first, do Exercise A Following Instructions

Hand to 2 or more people a sheet of 8 1/2 x 11 paper and ask them to individually follow instructions.

The instructions are: . FOLD THE SHEET OF PAPER IN HALF . TEAR OFF THE TOP LEFT CORNER . TEAR OFF THE BOTTOM LEFT CORNER . FOLD THE SHEET IN HALF AGAIN . TEAR OFF BOTTOM RIGHT CORNER . TEAR OFF BOTTOM LEFT CORNER --- UNFOLD !!!

With the exact same instructions given to the 2 or more people, do you expect the results to be

exactly the same?

No !!! of course not !!!

“The instructions were not specific enough”.

****

A general rule:

Instructions are required where in their absence problems are likely to occur.


Task 15 Plan the training and review Clauses 4 thru 8 of AS9100C You will have to become familiar with the requirements of the AS9100 Standard released for the Aviation, Space & Defense industry. This means that you will have to read and perhaps re-read the different section of AS9100C and get some training to help you understand the requirements. Training Options are available, where for example and under the direction of the Management Representative: 1. Use the AS workbook and have your personnel identified as members of the AS Steering Team and the Quality Team go through the Task 15 Exercises on their own and bring questions and concerns to the weekly Quality Team meetings. 2. Use the AS workbook over several workshop sessions and have your personnel identified as members of the AS Steering Team and the Quality Team go through the Task 15 Exercises as a group and have questions and concerns addressed. Above 2 options are more suited for small and medium size companies. 3. In larger companies, the Management Representative schedules the AS training over a longer period of time where one exercise at a time is completed. Training can be spread over a period of 4 to 6 weeks where one topic/requirement of AS9100 is examined at one time. --------------------------------------------------------------------------------------------------------------------------- A typical schedule can be confirmed as: Wed April 1 Clause 4 Exercise B Date confirmed: ____________ by: _______ Wed April 8 Clause 5 C ____________ by: _______ Wed April 15 Clause 6 D ____________ by: _______ Wed April 22 Clause 7 E ____________ by: _______ Wed April 29 Clause 8 F ____________ by: _______ Wed May 6 Risk Analysis G ____________ by: _______

Comments: ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Prepared by: …………………………………….. Date: …………………….


AS9100

Requirements

Instructions for the review of the

requirements

Activities currently being done / Activities required

-- YES -- In

Compliance

-- NO -- Needs

Attention Clause # 4 Quality Management System

Task 15 QMS Workshop

Exercise B Clause 4.1 to 4.2

An essential prerequisite for this exercise is to have at your company location the latest publication of the AS9100 standard. And with the execution of Task 3 in the AS9100 Workbook, this document will be available for use with this exercise.

Take the time to review the requirements of Clause 4. Read each paragraph of clause 4 and in the 3 right hand columns:

• Describe what you are currently doing to comply with the requirements.

• Identify where you will need to implement new activities.

Existing activities that may already comply with the standard and New activities that need attention will become part of your quality management system – QMS.

------

------

4 Quality management system 4.1 General requirements

Read paragraph 4.1 General requirements, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual

Read paragraph 4.2.1 General , and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------ Read paragraph 4.2.2 Quality manual, and in the right hand columns: Describe what you are currently doing to comply with the requirements.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


4.2.3 Control of documents 4.2.4 Control of records

Identify where you will need to implement new activities. ------------------------------------------------------ Read paragraph 4.2.3 Quality manual, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------ Read paragraph 4.2.3 Quality manual, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


AS9100 Requirements


requirements


-- YES -- In

Compliance

-- NO -- Needs

Attention Clause # 5 Management Responsibility


Exercise C Clause 5.1 to 5.6





Existing activities that may already comply with the standard and New activities that need attention will become part of your QMS.

------

------

5 Management responsibility 5.1 Management commitment

Read paragraph 5.1 Management commitment, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

……………………………………………………………… ……………………………………………………………… ……………………………………………………………… ……………………………………………………………… ……………………………………………………………………………………………………………………………… ……………………………………………………………… ………………………………………………………………

5.2 Customer focus

Read paragraph 5.2Customer focus, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

5.3 Quality policy

Read paragraph 5.3 Quality policy, and in the right hand columns: Describe what you are currently doing to comply with the requirements.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


Identify where you will need to implement new activities.

………………………………………………………………… …………………………………………………………………

5.4 Planning 5.4.1 Quality objectives 5.4.2 Quality management system planning

Read paragraph 5.4.1 Quality objectives, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 5.4.2 Quality management system planning, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority 5.5.2 Management representative

Read paragraph 5.5.1 Responsibility and authority, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 5.5.2 Management representative, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


5.5.3 Internal communication

Read paragraph 5.5.3 Internal communication, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………………………………………………………………………………………………………………………………………………

5.6 Management review 5.6.1 General 5.6.2 Review input 5.6.3 Review output

Read paragraph 5.6.1 Management review, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 5.6.2 review input, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 5.6.2 review input, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


AS9100 Requirements


requirements


-- YES -- In

Compliance

-- NO -- Needs

Attention Clause # 6 Resource Management


Exercise D Clause 6.1 to 6.4






------

------

6 Resource management 6.1 Provision of resources

Read paragraph 6.1, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training

Read paragraph 6.2.1, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

---------------------------------------------


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


6..3 Infrastructure


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

6.4 Work environment


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


AS9100C Requirements


requirements


-- YES -- In

Compliance

-- NO -- Needs

Attention Clause # 7 Product Realization

Task 15 QMS

Workshop

Exercise E

Clause 7.1 to 7.6






------

------

7 Product realization 7.1 Planning of product realization 7.1.1 Project management 7.1.2 Risk management


-------------------------------------------


----------------------------------------------


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ……………………………………………………………….. ……………………………………………………………….. ………………………………………………………………... ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


7.1.3 Configuration management 7.1.4 Control of work transfers


----------------------------------------------


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ……………………………………………………………….. ……………………………………………………………….

7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer communication

Read paragraph 7.2.1 and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

---------------------------------------------

Read paragraph 7.2.2 and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

--------------------------------------------

Read paragraph 7.2.3 and in the right hand columns:

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

7.3 Design and development 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development review


-------------------------------------------


-------------------------------------------


---------------------------------------------


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.6.1 Design and development verification and validation testing 7.3.6.2 Design and development verification and validation documentation 7.3.7 Control of design and development changes


-------------------------------------------


-------------------------------------------

Read paragraph 7.3.6.1, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

-------------------------------------------

Read paragraph 7.3.6.2, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

--------------------------------------------

Read paragraph 7.3.7, and in the right hand columns: Describe what you are currently doing to comply with the requirements.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ……………………………………………………………….. ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………



………………………………………………………………… …………………………………………………………………

7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product

Read paragraph 7.4.1, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. -------------------------------------------------------- Read paragraph 7.4.2, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 7.4.3, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

7.5 Production and service provision 7.5.1 Control of production and service provision


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


7.5.1.1 Production process verification 7.5.1.2 Control of production process changes 7.5.1.3 Control of production equipment, tools and software programs 7.5.1.4 Post-delivery support 7.5.2 Validation of processes for production and service provision

Read paragraph 7.5.1.1, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 7.5.1.2, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------ Read paragraph 7.5.1.3, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 7.5.1.4, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ---------------------------------------------------- Read paragraph 7.5.2, and in the right hand columns: Describe what you are currently doing to comply with the requirements.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


7.5.3 Identification and traceability 7.5.4 Customer property 7.5.5 Preservation of product

Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 7.5.3, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. ------------------------------------------------------- Read paragraph 7.5.4, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities. -------------------------------------------------------- Read paragraph 7.5.5, and in the right hand columns: Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

7.6 Control of monitoring and measuring devices


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


Clause 7 Product Realization – Inclusion / Exclusion Justification Worksheet – see also Task 9 b

AS9100C Clause 7

Requirements

Justification for Inclusion or Exclusion in Product Realization section 7 of the QAM

Requirement applicable Yes - No

Remarks

7.0 PRODUCT REALIZATION -- ---

7.1 Planning of product realization

7.2 Customer related processes

7.3 Design and development

7.4 Purchasing

7.5 Production and service provision

7.5.2 Validation of processes for production and service provision

7.5.4 Customer property

7.6 Control of monitoring and measuring Devices


Clause 7 Product Realization – Inclusion / Exclusion Justification Worksheet – example

AS9100C Clause 7

Requirements

Justification for Inclusion or Exclusion in Product Realization section 7 of the QAM

Requirement applicable Yes - No

Remarks

7.0 PRODUCT REALIZATION

Additional details are included in the completed Scope and Processes - QMS Worksheet #400-1

-- ---

7.1 Planning of product realization Planning is required Yes F-400-1

7.2 Customer related processes Customer requirements are very important Yes

7.3 Design and development Design of products is the full responsibility of the company

Yes

7.4 Purchasing Raw materials, components, supplies, outsourced services are required

Yes

7.5 Production and service provision

Processes are required to be performed under controlled conditions

Yes As identified in F-400-1

7.5.2 Validation of processes for production and service provision

The nature of ‘Our-Products’ is such that customer requirements can be met with production technology where the resulting output can be verified by subsequent inspections.

No --

7.5.4 Customer property The nature of ‘Our-Products’ is such that customer requirements can be met with existing product components and customer property is not required to be supplied.

No ---

7.6 Control of monitoring and measuring Devices

A system is required to provide for the control of the inspection and calibration of measuring equipment used to demonstrate conformance to specified requirements and to assure confidence in the results obtained.

Yes


AS9100C Requirements


requirements


-- YES -- In

Compliance

-- NO -- Needs

Attention Clause # 8 Measurement, analysis and

improvement

Task 15 QMS

Workshop

Exercise F

Clause 8.1 to 8.5






------

------

8 Measurement, analysis and improvement 8.1 General


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

8.2 Monitoring and measurement 8.2.1 Customer Satisfaction 8.2.2 Internal audit


---------------------------------------------

Read paragraph 8.2.2, and in the right hand columns: Describe what you are currently doing to comply with the requirements.

………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………


8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product


---------------------------------------------


---------------------------------------------


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

8.3 Control of nonconforming product


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

8.4 Analysis of data


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

8.5 Improvement

Read paragraph 8.5.1, and in the right hand columns:

………………………………………………………………… …………………………………………………………………


8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action

Describe what you are currently doing to comply with the requirements. Identify where you will need to implement new activities.

----------------------------------------------


----------------------------------------------


………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… ………………………………………………………………… …………………………………………………………………

Copyright©2009 Lorne Duquette Distributed by the9100store.com 66

Task 15 Exercise G Risk Management

Risk Management / Analysis of Risk

AS9100C

Clause 7 Product Realization of

Aviation, Space and Defense

(AS & D) Products

Exercise G deals with risk management and the analysis of risks throughout clause 7 for product realization.


Task 15 Exercise G Risk Management

Instructions: Conduct Risk Analysis for product realization steps required for your products. Consider the production steps and the activities/steps for all functions in your organization.

• Prepare process flow diagrams to describe the activities / steps.

• Make use of the Risk Management Worksheet to systematically conduct a risk analysis for each of the steps identified in each process flow diagram.

• Refer to worksheet.

Column 1 Transfer from the flow diagrams, the steps required for the process. Column 2 Identify what may be present or could be introduced as a risk. Column 3 Describe the risks that may be existing or could be introduced. Column 4 Assess the significance of the described risk. Indicate in sub-column 1, the severity of the risk as L for low, M for medium, and H for high. Indicate in sub-column 2, the likelihood of occurrence as Low, Medium or High. When both the Severity and Likelihood are High, the Significance in sub-column 3 is High, the process step is at risk, it requires attention and corrective action is required and indicated in the last column. When one or both severity and likelihood are indicated as medium, additional reviews are required and resulting actions justified (with inputs in columns 5 & 6. Cont’d ..


Column 5 For Low, Medium, and High significance risks, indicate if the risk can be eliminated or reduced in a next step in the process. Column 6 For all risks, describe what controls are in place to reduce or eliminate the risk. Column 7 The Quality Team considers the inputs from columns 1 through 6 and indicates with a NO or a YES whether or not the process step is a risk. Column 8 With a NO decision, a corrective action request (CAR) is not needed and N/A is indicated in this column. With a YES conclusion, the Management Representative (ref Task 4), enters a CAR # in the last column and prepares and issues a Corrective Action Request to the individual responsible for the process step. Notes: 1. It is important to make sure that if you do not have sufficient experience in your company to make the above determinations you involve outside expertise or use external sources of information to make the decisions. 2. Additional risk assessment methods are provided at the significance page of the worksheet.


Reference Task 11.c

Draw the Process Flow Diagram(s) for your operations

Comments: -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________

Purchase

Receive

Storage


Task 15 Exercise G Conduct Risk Analysis - Risk Management Worksheet

The first 6 columns of this form are used to list the Potential Risks and Assess the Significance of the Risks

The last 2 column of this form are used to indicate whether or not the Process Step is at risk and requires attention.

* Refer to the process flow diagram(s).

** Where both the Severity and the Likelihood are high, the risk is significant and the Process Step requires corrective action.

* Step

What is present or could be

introduced as a risk?

Description of Risk Significance 1 = Severity 2 = Likelihood 3 = Significance

**

Does a next step in

process eliminate the risk?

What controls exist to

address the risk?

Is the Process

Step at risk? Yes / No

** If YES, Issue the Corrective Action Request

--- --- ---- 1 2 3 Justifications CAR #

Compiled by Management representative: ___________________, Date: __________ Quality Steering Team review: 1_____________, Date: ______, 2____________, Date: _________



ACTION

1

ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Input Description of Risk

Significance 1 = Severity 2 = Likelihood 3 = Significance

**

Does a next step in



address the risk?

Is the Process Step at risk?

Yes / No

** If YES, Issue the

Corrective Action

Request


Explanatory Notes for the Actions required at each Column are provided ..


Task 15 Exercise G – Action 1 Conduct Risk Analysis - Risk Management Worksheet

ACTION

1

ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Input

Description of Risk


**

Does a next step in

process eliminate the

risk?


address the risk?

Is the Process Step

at risk? Yes / No


Corrective Action

Request


ACTION 1 STEP NUMBER AND NAME

Each process step identified in the process flow diagrams* at Task 11 needs to be transferred to this worksheet and numbered and named in the same sequence as the flow diagram.

This is to ensure that all aspects of the process are visible and controlled, not just the items that are at risk. Process Flow Diagrams can describe not only process steps in a production environment, but also sequential steps for administration and other management activities .. eg purchasing. This risk management worksheet can be used to analyze the risks associated with those activities.



ACTION

1 ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Inputs

Description of Risk


**

Does a next step in


risk?

What controls exist

to address the risk?

Is the Process Step

at risk? Yes / No

** If YES, Issue the Corrective

Action Request


ACTION 2 INPUTS

What exists or what could be introduced at this process step that could result in a problem and create a risk?



ACTION

1 ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Inputs

Description of

Risk


**

Does a next step in


risk?


address the risk?

Is the Process Step

at risk? Yes / No

** If YES, Issue the Corrective

Action Request


ACTION 3 What type of risk is presented by the introduction of these inputs?

Describe the risks when non-complying product characteristics result in areas of:

DIMENSIONAL (item too big, too small, too wide, too narrow, etc)

MATERIAL (too hard, too soft, etc)

APPEARANCE (too dark, too light, too rough, too smooth, etc)

FUNCTION .. Others ..



ACTION

1 ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Inputs

Description of Risk


**

Does a next step

in process eliminate the risk?


address the risk?

Is the Process



Corrective Action

Request


ACTION 4 What is the significance of the risk?

What is the severity of the risk in question and what is the possibility that it will occur at this step?

What is the significance of the identified risk to the product?

These questions are critical to the outcome of the Risk Analysis. Answers to the questions require sound understanding of the product and its processes by the Quality Team.

... cont’d


Task 15 - Exercise G, Action 4

Assessing the Significance of Risks

-----------------------------------------------------------------------------------------

With reference to Column 4 of the Risk Management Worksheet, a simplest

method of assessing the risks is to use the letters H or M or L to indicate

whether the Severity and Occurrence are high or medium or low.

H = High

M = Medium

L = Low

In general:

When both Severity and Occurrence are High, the process step is at risk and

requires attention.

When one or both the severity and the likelihood are indicated as medium,

additional reviews are required to identify existing conditions that reduce or

eliminate the risk.

----------------------------------------------------------------------------------------------------------

Below is a method to quantify the risks.

S = Severity of the Outcome

3 = High, 2 = Medium, 1 = Low

L = Likelihood of the Occurrence

3 = High, 2 = Medium, 1 = Low

R = Risk Level (L x S) or Significance of the Risk

1-3 = Low risk

4-6 = Medium risk

7-9 = Substantial risk


Significance of Risks

A variation in the method to analyze the Severity and Likelihood and assess the

Significance or risk associated with the process step.

• LOW = 0 – 33% of times that the risk might occur.

• MEDIUM = 34 – 66% of times that the risk might occur.

• HIGH = 67 – 100% of times that the risk might occur.

This method is based on actual experience with the process step.

----------------------------------------------------------------------------------------------------------

Other technical methods that provide guidelines for rankings of Severity,

Frequency, and Detection that result in a risk potential number, (R.P.N.) can be

used to assess risks.



ACTION

1 ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Inputs

Description of Risk

Significance 1 = Severity 2 = Likelihood 3 = Significance **

Does a next step

in process eliminate the risk?


address the risk?

Is the Process



Corrective Action

Request


Action 4 Significance of risks - Cont’d Indicate in sub-column 1, the severity of the risk as L for low, M for medium, and H for high. Indicate in sub-column 2, the likelihood of occurrence as Low, Medium or High. When one or both severity and likelihood are indicated as medium, additional reviews are required and resulting actions justified with inputs in next columns 5 and 6. When both the Severity and Likelihood are High, the Significance in sub-column 3 is High, the process step is at risk, it requires attentions and corrective action is required and indicated in the last column 8.



ACTION

1 ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Inputs

Description of Risk


**

Does a next step in process

eliminate the risk?


address the risk?

Is the Process



Corrective Action Request


Action 5 Does a next step in the process eliminate the risk?

Will a subsequent step in your process eliminate or reduce the risk to an acceptable level?

If yes, and for all risks identified, describe the subsequent steps in your process that will eliminate or reduce the risks.

If no, the process step is at risk and is a candidate for corrective action.



ACTION

1 ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Inputs

Description of Risk


**

Does a next step in


risk?

What controls exist to address

the risk?

Is the Process





ACTION 6 What controls exist at the process step?

What measures need to be taken to prevent, reduce or eliminate the risk?

Controls will vary on the type of risk and obviously their significance. For example the controls may focus on sourcing components from approved suppliers, who produce them under controlled conditions.

In some cases, there will be more than one control for an identified risk, and conversely, more than one risk may be controlled by a specified control. In certain instances, control measures may not be required due to the absence of any significant hazards at that step.



ACTION

1 ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Inputs

Description of Risk


**

Does a next step in



address the risk?


Yes / No




ACTION 7 Is the process step at risk?

Answers to this critical question require sound understanding of the product and its processes by the Quality team.

Answers depend on the Significance and Justifications provided at Actions 4, 5 & 6.

The Quality Team considers the inputs from columns 1 through 6 and needs to decide and indicate whether or not the process step is at risk and requires further attention. However, a general rule is that *** when both the severity and likelihood are indicated as high at Action 4, the significance of the risk is high and the process step is a risk point.



ACTION

1 ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Inputs

Description of Risk


**

Does a next step in



address the risk?


Yes / No




ACTION 8 Is corrective action taken to address a risk at the process step?

With a NO decision is taken at action 7, a corrective action request (CAR) is not needed and N/A is indicated in this column 8. With a YES conclusion taken at action 7, the Management Representative (ref Task 4), enters a CAR # in the last column and prepares and issues a CAR to the individual responsible for the process step.



As demonstrated in the previous pages, the 8-column risk management worksheet can be an effective tool to systematically work through the actions required and record the specific information that will lead to a practical resolution to the elimination or reduction of risks.

ACTION

1

ACTION

2

ACTION

3

ACTION

4

ACTION

5

ACTION

6

ACTION

7

ACTION

8

* Step Input Description of Risk


**

Does a next step in



address the risk?


Yes / No


Corrective Action

Request


When applicable for preventive actions, risks can be managed and minimized through the use of the FMEA methodology ... See next page for additional information.


Task 15 Exercise G Product Realization and Risk Management in clause 7 – cont’d In AS9100C, Risk Management is a requirement that is mentioned at par 7.1.2 where: As appropriate to your company and your product, you will need to establish, implement and maintain a process for managing risk while achieving conformity to applicable requirements that includes: a) assignment of responsibility for risk management b) definition of risk criteria, for example likelihood, consequences, risk acceptance c) identification, assessment and communication of risks throughout product realization d) identification, implementation and management of actions to mitigate risks that exceed the defined acceptance criteria, e) acceptance of risks remaining after implementing mitigating actions. However, since risk management is part of product realization par 7.1.2 and is referenced in the review of requirements related to products at par 7.2.2 and noted in the preventive action par 8.5.3, the FMEA can become the methodology to document the requirement for risk management. Therefore in addition to analyzing risks at the production steps and at the activities / steps for all functions through the use of the 8-column risk management worksheet, risk management can be identified during the review of requirements related to products and considered in the preventive action process. Process FMEA stands for Process Failure Mode & Effects Analysis. It is a tool typically used by Engineering and/or Quality that identifies and quantifies risk associated with potential product and process failures. View the FMEA tutorial

_____________________________________________________________


Task 15 Exercise G Product Realization and Risk Management - Conclusion _________________________________________________________________________

To complete this task, direction from the AS9100 Steering Team is required to determine: a. Have the risks associated with the product realization of your aerospace products or services been sufficiently addressed with the 8-column risk management worksheet? ____ Yes ____ No If yes, manage the identified risks through the Risk Management Worksheet. If no, consider the question below. b. Is the FMEA methodology applicable to our products and processes to further identify and quantify the risks associated with them? ____ Yes ____ No Comment ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Prepared by: _________________________ Date: _________


Task 16 Manage the Implementation of your Quality Management System

For the AS9100 Quality Management System Use project management techniques such as a Task and Timing Table (next page) to identify the Significant Dates that will keep the Program momentum moving toward a Target registration / certification date!! For the AS9100 QMS The Quality management representative is the Project Manager .. and is supported by the AS Steering Team and the Quality Team Members Timing chart Up-Dates will be needed to indicate the progress made and to keep the Program momentum moving toward a Target date ….…. 12 to 16 months !!

Comments: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by: __________________________ Date: ______________


Task 17 - AS9100 QMS Timing Chart

# IDENTIFIED TASK 1 2 3 4-5 5-7 8-9 10-11 12 13 14 15 16

A Preparation phase – Tasks 1-10

1 Describe your organization

2 Decide on Management System to be implemented

3 Obtain latest AS9100 standard

4 Select the Management representative + AS Steering Team

5 Update / Prepare Organization chart

6 Establish the Quality Team

7 Conduct Quality Team meetings

8 Formulate and publish the Quality Policy and objectives

9 Determine the Scope of the QMS

10 Identify the interrelated requirements

B Development Phase-Tasks 11-21

11 Identify processes, describe processes and draw process flow diagrams

12 Provide communication tools - AS bulletin board

13 Conduct a preliminary assessment of existing system - checklist

14 Assign and implement improvement actions identified during assessment

15 Provide AS training – Exercises A – F Exercise G - Risk management

16 Manage implementation of the Quality program


17 Maintain / Update Implementation timing chart – this chart

18 Collect existing documentation - forms, tags, procedures, instructions

19 Do financial study to justify costs vs benefits

20 Re-Confirm your AS9100 decision Task 2

21 Promote and Practice TEAMWORK

C Implementation Phase-Tasks 22-26

22 Obtain / Review / Study QMS Manual model / template

23 Use model as a template to generate the QMS documentation

24 Implement the QMS Procedures ---- ---- ----

24a Finalize and Approve Quality Manual

24b Implement Document control procedure,

24c Implement Control of records procedure,

24d Implement the Planning procedure,

24e Implement the Responsibility and authority procedure,

24f Implement Training procedure

24g Implement Maintenance procedure

24h Etc .. as identified from QMS template

24i Etc.

25 Select, train auditors and conduct the internal audit

26 Conduct the management review


D Registration Phase-Tasks 27-28

27a Select the registrar

27b Perform Stage 1 Readiness review – by registrar

27c Conduct Stage 2 registration audit – by registrar

28 Receive the Quality Management AS & D Certificate

!!! CELEBRATE !!! - Maintain and Improve the QMS


Task 18 Collect existing documents ======================================================================

Part 1

Collect any formal or informal Forms and Tags that are currently used in your operations.

• A short note (on a post-it label) can summarize what the form or tag is used for, what it does, and who uses it.

________________________________________________________________________

Part 2 Collect any formal or informal Procedures and Instructions currently used by the departments of the company.

� Provide a short summary of the procedures or instructions to describe what they are and what they are used for.

________________________________________________________________________ A collection of this ‘Information’: – Forms, Tags, Instructions and Procedures will be very useful in the development of the AS9100 Quality Management System. - Information will be needed and used during the procedure development phase. Comments: -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Info collected by: __________________________ Date: ______________


Task 19 Perform a financial study / review to Justify the Costs versus the Benefits

Comments: --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by: __________________________ Date: ______________

QMS = Return on Investment = ROI


Task 20 RE-CONFIRM the AS DECISION for your COMPANY: ___________________________ Options for Management Systems:

• AS9100 - Quality Management System – Design, development, production and installation.

• AS9110 - Quality Management System – Maintenance activities.

• AS9120 - Quality Management System – Stocklist Distribution.

• ISO 9001:2008 – Quality Management System

In my organization, the management system best suited for our AS & D activities is:

AS9100 Rev C for QUALITY MANAGEMENT SYSTEMS

YES, @ ___________________________ (your company),

We remain committed to the implementation of:

AS9100 QUALITY MANAGEMENT SYSTEMS

Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________

Task 21 Promote and practice TEAMWORK

• The complexity of most of the processes that are operated in industry and the services place them beyond the control of any one individual.

• The only way to tackle problems concerning such processes is through the use of some form of teamwork.

• The use of the team approach to problem solving is an essential component of the implementation of a Quality Management System, because it builds up trust, improves communications and develops inter-dependence.

• Encouragement of ideas and suggestions from the workforce, particularly through their involvement in team or group activities, requires investment but the rewards are total


involvement, both inside the organization and outside through the supplier and customer networks.

T.E.A.M

T = Together

E = Everyone

A = Accomplishes

M = More

_______________________________________________________________

List some ways that you can use to promote & practice TEAMWORK in your company:

• Motivation

•

•

• Commitment

Prepared by: _____________________________ Date: __________




Section 3: The Implementation and

Registration Phase


Section 3: The Implementation and Registration Phase Implementing your AS9100 QMS Responsibility: AS Steering Team This section of the workbook includes the steps to complete the design, implementation and documentation of your AS9100 QMS. The AS Steering Team will assign responsibilities and timeline for tasks 22 through 28 (See your Timing Chart at Task 17)

Task 22: Obtain and Review a Model for a QMS Manual Task 23: Use the Model as a Template to generate QMS documentation Task 24: Implement the Quality Management System Task 25: Conduct Internal Audit of the QMS Task 26: Conduct the Management Review Task 27: Select a Certification Body to register the QMS Task 28: Receive Certification and Celebrate!


Task 22 Obtain & Review a Model for a QMS Manual

• Review / Study the QMS Manual Model / Template for a typical AS & D Quality Management System.

• Visit as9100store.com for a complete manual template to match this workbook

Comments: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________


Task 23 Use the Model as a Template

Use the Model and Customize a Manual to reflect your own AS9100 Quality program

This is a Major Task .. The Quality Team needs to be very active and involved.

It will take time to finalize the documents for the Procedures and Instructions.

To obtain consistent results, very specific details are detailed for each of the Procedures and Instructions. A consistent format is helpful to cover:

• Purpose

• Scope

• Responsibility

• Instructions / Procedure

• Documentation

• Revisions

A total of 6 to 9 months will likely be required for all final internal approvals to be

in place.

Follow the sequence of activities as shown on Process Input-output Worksheet #F- 400-1 and take into account the inputs from the AS exercises B thru F to develop the documentation.

Follow-Up on the activities through the ‘weekly’ Quality Team meetings, (Task 7).

Comments: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prepared by; __________________________ Date: ______________


Task 24 Implement the Quality Management System

Implement the procedures identified for the AS9100 QMS Obviously another Major Task .. The Quality Team needs to be very active and involved.

It will take time to implement the Operating Procedures.

As they are approved by the responsible person, an additional 2 to 3 months will likely be required for all to be in place.

Follow the sequence of activities as shown on Process Input-output Worksheet

#F- 400-1 to develop the documentation.

Follow-Up on the activities through the ‘weekly’ Quality Team.

24. a Approve QMS Manual President Promise _____ date

24. b Implement Doc control Management Representative Promise _____ date

24. c Implement Records Management Rep Promise _____ date

24. d Implement Planning Management Rep Promise _____ date

24. e Implement etc. Personnel Manager Promise _____ date 24. f etc

Comments: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prepared by; __________________________ Date: ______________


ASSESSMENT OF CURRENT SITUATION. The business is fairly straightforward. For the majority of the products, components are fabricated and assembled to other purchased parts and shipped as finished goods to the customers. There are 5 distinct processes each with activities and tasks that must be controlled.

The processes (1 to 4) controlled and incorporated in the QMS are: 1- Sales and order entry, 2- Purchasing and material control, 3- Production and shipping, 4- Management and administration. Ref 5- Accounting and financial control. This worksheet is used to identify, plan and integrate the activities that are required for each process of the QMS.

SCOPE OF THE QMS: The scope of the Quality Management System includes the major product service categories associated with: Design and development and manufacture of components, assemblies and products for : (Indicate your products) such as Tires used in the landing gears of aircrafts.

PROCESS INPUTS – Form F-400-1

AS9100C Quality Management Systems Requirements

PROCESS OUTPUTS – Identification of key processes & sub-processes

DOCUMENTATION

for Processes

RESPONSIBILITY for Processes

REMARKS

4.0 QUALITY MANAGEMENT SYSTEM 4.1 General requirements 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual

4.2.3 Control of documents

4.2.4 Control of records

From Exercise B [ [ [ [ [

Consider the Documentation Package from as9100store.com

5.0 MANAGEMENT RESPONSIBILITY 5.1 Management commitment 5.2 Customer focus 5.3 Quality Policy 5.4 Planning

From Exercise C [ [ [ [


5.4.1Quality objectives 5.4.2 Quality management system planning 5.5 Responsibility, authority & communication 5.5.1 Responsibility and authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management Review 5.6.1 General 5.6.2 Review input 5.6.3 Review output 6.0 RESOURCE MANAGEMENT 6.1Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training 6.3 Infrastructure 6.4 Work environment

From Exercise D [ [ [

7.0 PRODUCT REALIZATION 7.1 Planning of product realization 7.1.1 Project management 7.1.2 Risk management 7.1.3 Configuration management 7.1.4 Control of work transfers 7.2 Customer related processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer communication

From Exercise E [ [ [ [ [ [ [


7.3 Design and development 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.6.1 Design and development verification and validation testing 7.3.6.2 Design and development verification and validation documentation 7.3.7 Control of design and development Changes 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased products 7.5 Production and service provision 7.5.1Control of production and service provision 7.5.1.1 Production process verification 7.5.1.2 Control of production process changes 7.5.1.3 Control of production equipment, tools and software programs 7.5.1.4 Post-delivery support 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and Traceability 7.5.4 Customer property 7.5.5 Preservation of product 7.6 Control of monitoring and measuring devices


8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT 8.1 General 8.2 Monitoring and measuring 8.2.1Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1General 8.5.2 Corrective action 8.5.3 Preventive action

From Exercise F [ [ [ [ [

Compiled by: Quality Team ______________, ________________, ______________, ______________, _________________ Worksheet form #400-1 Date started: _______________ Date completed: ________________


Task 25 Conduct Internal Audit of the QMS

Conduct Internal Audit

Select the internal auditors

Obtain training for the internal auditors

Conduct internal audit

Use procedure and questionnaire / checklist .. from model / template

Note that a procedure QP-822c for internal audits is available in our AS9100C QMS Documentation package.


Comments: --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Prepared by; __________________________ Date: ______________


Task 26 Conduct Management Review of the QMS

Conduct a management review – See next page for the Management Review Agenda.

Use procedure .. from model / template

Note that a procedure AP-500c for management responsibility is available in our AS9100C QMS Documentation package.


Prepare facility for Registration Audit

1. Do housekeeping / clean up / etc

2. Apply ISOAP, the soap used to clean up prior to a registration audit.



MANAGEMENT REVIEW – QMS-AGENDA

DATE : VENUE: _______________________________ TIME :__________________

COME PREPARED TO DISCUSS THE FOLLOWING AGENDA ITEMS:

1. Results of Internal Quality Audits 2. Customer feedback to products / services provided 3. Process performance / Product conformance 4. Status of Corrective / Preventive actions 5. Follow up actions from earlier reviews 6. Changes affecting the QMS – review data for:

Quality Policy & Objective Organization chart Quality objectives planning – programs Identification of key processes & sub-processes, F-400-1

7. Recommendations for improvement 8. Identification of new or revised regulations Other optional topics: 9. ______________________________________________________ 10. ______________________________________________________

11. QMS planning-Effects of upcoming projects, status of on-going project on QMS

12. Resources – people & training, facility & equipment 13. Overall QMS effectiveness

PARTICIPANTS INITIALS DATE 1.________________________________________________________ 2.________________________________________________________ 3.________________________________________________________

4.________________________________________________________

5.________________________________________________________

6.________________________________________________________

7.________________________________________________________

8.________________________________________________________

Prepared by: Date: ____________


Task 27 QMS Registration / Certification

Select a Certification body / Registrar ..

• Early, within first 5 months

• Budget to cover the costs

Registrar performs Stage 1 Readiness audit including a documentation review, after your procedures are finalized and approved.

Registrar performs Stage 2 Registration audit, approximately 3 months after you have used your QMS and generated sufficient records to prove that your are in compliance.

See next page for additional information on the registration process and details for Stage 1 and Stage 2 assessments.



Task 27 QMS Registration / Certification – cont’d

The process of registration follows three simple steps:

1. Your organization makes application for registration by completing the registrar’s AS 9100 questionnaire. 2. Assessment to AS 9100 is undertaken by the registrar – your organization must be

able to demonstrate that the quality management system has been fully operative for a minimum of three months and has been subject to a full cycle of internal audits.

3. Registration as granted by THE REGISTRAR is valid for a period of three years and is

maintained by your organization. Maintenance is confirmed through a program of annual surveillance and a re-certification audit in three years.

Initial Certification Audit – The assessment process for achieving certification consists of a two stage initial certification audit as follows:

Stage 1 – The purpose of this review is to confirm the readiness of your organization for full registration assessment. The assessor will:

• confirm that the quality manual complies to the requirements of AS 9100,

• confirm its implementation status,

• confirm the scope of certification,

• check legislative compliance,

• produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required,

• produce an assessment plan and confirm a date for the Stage 2 assessment visit

Stage 2 – The purpose of this audit is to confirm that the quality management system conforms to the requirements of AS 9100 in practice. The assessor will:

• undertake sample audits of the processes and activities defined in the scope of assessment,

• document how the system complies with the standard,

• report any non-compliances or potential for non-compliance,

• produce a surveillance plan and confirm a date for the first surveillance visit, If the assessor identifies any major non-conformance, your organization cannot be registered until corrective action is taken and verified.


Task 28 Receive Quality Management System Certification

For your AS9100 QMS �Address non-conformances, if any, found during the audit �Receive Quality Management System Certificate �CELEBRATE your Stardom !! �CELEBRATE your AS9100C QMS Accomplishment !!!

Comments: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prepared by; __________________________ Date: ______________

AS9100c Workbook

Documents

auditors inspectors

conduct preliminary

bottom left

quality team

program momentum

process flow

resulting

quality management