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ISO 9001 Basics and its use in ISO 9001 Basics and its use in energy EPC business energy EPC business Lynda Harned Black & Veatch Director, Energy QMS
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Page 1: Iso 9001 Used in an Energy Epc Business

ISO 9001 Basics and its use in ISO 9001 Basics and its use in energy EPC businessenergy EPC business

Lynda Harned

Black & VeatchDirector, Energy QMS

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Agenda: Quality Management In an Energy EPC company

The necessary people and systems

Voice of the employee – deviation requests & continual Improvement

Audit & assessment systems - trust everyone, verify what matters

Continual improvement

Cost of quality

Enhancing client satisfaction

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The necessary people & systemsThe necessary people & systems

Your clients

Your leadership

Your management system

Your process owners

Your project / process implementers

Your clientsYour clients

Your leadership Your leadership

Your management systemYour management system

Your process ownersYour process owners

Your project / process implementersYour project / process implementers

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Client satisfaction and sustainabilityClient satisfaction and sustainability

Real profits are generated by loyal clients – not just satisfied clients

- Aguayo

Real profits are generated by loyal clients – not just satisfied clients

- Aguayo

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Ensuring the client is getting what they need and want

Knowing their current business and future needs, knowing legislation and future requirements, evaluating trends in the global market and providing recommendations in their best interest

A QMS that is nimble but controlled which ensures client expectations and requirements are included and verified for incorporation into design through delivery

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What your client wants and needs

Ensuring that the clients requirements are determined and are met with the aim of enhancing satisfaction and future opportunities

Asking

Listening

Document and submit

Clarification

Following through

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Leadership’s Role In the

Quality Management System

Leadership’s Role In the

Quality Management System

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Your leadership’s role in quality management system

Their authority, ownership and accountability in the quality management system

Their support in the form of time, responsiveness, resources, and communication

Provide support groups for the process owners and the implementers

The quality department can not and should not own the entire QMS

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Process owners (Leadership) and ownership

Process owners manage their processes and communicate process knowledge to those expected to implement it

Internal project teams receive and apply process knowledge as well as define process needs and improvement opportunities back to the process owner

Together, all professionals help drive process improvement through the learning, understanding and sharing of information about effectiveness and efficiency back to the process owner

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Engineered system criticality: Acceptance criteria defined, review/inspect points, verify/test point, analysis by process owner or designee, and approval.

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Process ownership – Managing your process

Defining and documenting the process by developing templates, standards, guides, manuals or a process flowcharts to depict the key requirements, actions and attributes associated with their process and facilitate effective training

QMS supports all elements of business, from the proposal review process, permitting, FEED, project reviews, engineering through the pre-commission, start-up and warrantee periods

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Process owner responsibility: Training to the QMS

Global Basic QMS Training – Understanding the key processes within a QMS: Required training, deviation request, corrective and preventive process, creation, review and approval

Project Specific Training – Global offices use of the computer applications, project personnel capability evaluation, project specific QMS requirements, project specific training plans, deviation requests

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Your Support SystemsYour Support Systems

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Your management systems

Document Management system

Training Management system

Personnel Qualification management

Review and assessment systems

Corrective Action system

Preventive Action: Continual Improvement

Records Management

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Managing your operational process procedures

Document Management, having a means of controlling, maintaining and making your companies procedures available to those expected to follow them

We have 850 Standards & Guides, so we have three tiers of governance document system

120 Process owners worldwide have been identified, these professional are the owners of the QMS Standards and Guides

Required review cycle so that they are maintained

Electronic Document Management System

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Training Management System

Training plans defined by role

Required reading to QMS standards

Technical training: classroom, e-learning

Process owner responsibility to help define

Electronic system to manage training

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Personnel Qualification Management System

Experience

Education

Training

Skills

Managed within an electronic system

Access to project management team to help evaluate team readiness

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Review, assessment and audits

Project criticality: complexity, location, structure review and audit

Engineered system criticality: Acceptance criteria defined, review/inspect points, verify/test point, analysis by process owner or designee, and approval. – Review and Audit

Product criticality: Inspection and Test Plan

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Your Project and Process ImplementersYour Project and Process Implementers

The professionals getting the deliverables ready for your clients

The professionals getting the deliverables ready for your clients

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Voice of the internal client Deviation Request Process

Deviation requests are generated by the professionals using the QMS explains why and what will be done differently

The owner of the process reviews and determines to allow or reject

Deviations copies are maintained and made available to owner when it time to up-date process / procedure

The key to making your system come to life

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Role of the Preparer

Ensure the information within the report / document is complete, accurate, suitable, meets both applicable

internal QMS standard requirements and external client and code requirements prior to requesting internal

review and comments

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Review and verification

Verify the suitability, adequacy and effectivenessof the subject report to achieve established objectives

By signing it is meant to provide the preparer with assurance that the report has been reviewed and verified and found to be accurate, adequate and suitable for its intended purpose or provides comments to help it get there prior to seeking final approval

Role of the reviewer:

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Reviewers methods of verification

Alternative calculations

Comparing a new design specification with similar proven design specifications

Undertaking test and demonstrations

Reviewing documents prior to use: right charts or tables used, right template used, right criteria and assumptions

Verification includes:

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Approval purpose

Ensure final design / reports are in a form suitable for use by the client

Design / report outputs shall:

Meet the input requirements for the deliverable

Provides appropriate information

Contain or reference deliverable acceptance criteria and

Specify the characteristics of the deliverable essential for it proper use and its limitations

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Role of the approverRead it as if you were the client reading it for the first time!

Final product presents well

Grammar

Spelling

Format

Attachments

References

Page numbers

Correct level of Information

Applicable QMS Standards satisfied

Contract deliverable requirements satisfied

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Continual ImprovementContinual Improvement

Audits

Root Cause Analysis

Process Ownership

Cost of Quality

Audits

Root Cause Analysis

Process Ownership

Cost of Quality

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Quality System Audits

Trust Everyone, Verify EverythingProcess and Compliance Audits

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Purpose of an Audit:

Audits are performed for the sole purpose of determining that YOU are doing things WRONG !!!

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Audits provide process owners with information about the health of their processes

Implementation

Suitability

Effectiveness

Adequacy

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Process Owners and Audits

Process owners involved in audit entrance meetings

Process Owners are the ones that issue the audit generated Corrective Actions Request and follow-up on closure

Process Audits – across projects, business lines and global offices. If trends show process gaps, process owners get CARs along with projects.

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Not the number of CARs issuedNot the number of CARs issued

Performance metric should be the Performance metric should be the duration that CARs remain open upon duration that CARs remain open upon agreed closure dateagreed closure date

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Access to QMS Audit Reports

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The significant problems we face today can not be solved with the same level of thinking we were at when we created them.

Albert Einstein

The significant problems we face today can not be solved with the same level of thinking we were at when we created them.

Albert Einstein

Root Cause Analysis

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Problem statement created and agreed upon

Time line – logic flow diagram created by those involved, not the process owner

Solution owners are usually our process owners

solutions are tracked to ensure completion

RCA solutions are one of the inputs to the next year’s audit schedule to ensure the solutions were effective

RCA reports are distributed and accessible on-line

RCA process & results

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Cost of QualityCost of Quality

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Why care about Cost of Quality? It’s all about the money!

Prevention: Policies and standardsTrainingRCA

Appraisal: Inspections, assessments,reviews and auditsDesign reviews

Failure:ReworkScrapRepairHigher insuranceRCACAROur reputation –how much is that worth?

Cost of ConformanceCost of Conformance Cost of NonconformanceCost of Nonconformance

Presenter
Presentation Notes
The ISO 9001 standards are a set of international quality management system standards and guidelines. Since their initial publication in 1987, they have earned a global reputation as the basis for establishing quality management systems. The 1994 version of ISO 9001, 9002 and 9003 standards have been used extensively as the basis for independent (third party) quality system certification. This has resulted in the certification of around 400,000 organizations worldwide, with many more in the process of setting up and implementing quality management systems.
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Cost of Quality Goal: Balanced Performance

Cost of Qualityper Good Unit

of Product

100% Defective 100% Good

Optimal COQ

Appraisal andPrevention Costs

Internal andExternal Failure Costs

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Construction and Startup Phase(Rework or Red Line

Deliverables)

Manufacturing Phase(Verify or Check Deliverables)

Design Phase(Create Purchase Orders,

Drawings and Calculations)

Development Phase(Plan)

Pre-Contract and Contract Review(Define Scope, Functions and

Acceptance Criteria)1

5

10

50

> 200

The cost of fixing errors

Presenter
Presentation Notes
In the same survey (you can use dollars or hours) The bad new is that these measurements are still accurate today in 2001. We just haven’t gotten any better.
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Total Quality CostCost Category Percent of Total

Prevention Appraisal Internal failure External failure

0-5 10-50 20-40 20-40

100

External failure

Internal failure

Appraisal

Prevention

80

60

40

20

0

Saving sustainability

Current Future

Total Quality Cost

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Questions & CommentsQuestions & Comments

Thanks and I appreciate your attendanceThanks and I appreciate your attendance