Audit Report - Q1
Audit ReportDoc ID: FM-198.Q1Revision: 1.0Effective Date:
5/30/2014
ContentsAudit Information2Audit Time Summary3Audit
Summary3Conclusion / Recommendation4Opening / Closing Meeting
Attendance Sheet5Findings Summary6Audit Report7Verification of
Scope of Registration / Monogram License(s) and Exclusions7Use of
API Monogram, APIQR and ANAB Marks8Quality Management System
Requirements9Communication Processes10Management
Responsibility10Documentation Requirements11QMS Monitoring,
Measurement, Analysis, and Improvement13Management Review13Analysis
of Data14Process Evaluation14Internal Audits14Improvement Processes
Corrective / Preventive Action15Product Realization16Audit
Conditions16Planning17Contract Review / Customer Related
Processes18Risk Assessment & Management19Contingency
Planning19Design & Development20Purchasing22Product Quality
Plan(s) (as applicable)23Production and Servicing
Processes24Product Release28Control of Testing, Monitoring and
Measuring Equipment29Control of Nonconforming Product29Management
of Change30Human Resources / Competence / Training
Processes30Supplemental Audit Information32Audit Package
Checklist32
Audit Information
Facility ID: Audit ID:
Facility Name:
Lead Auditor:
Audit Team Members:
Audit Start Date:Audit End Date:
Audit Type (Initial, Surveillance, Re-audit, etc.):
Audit Criteria:API Spec Q1API Spec Q2OHSAS 18001
ISO 9001ISO 14001
API Spec(s) (list all applicable specifications):
Other criteria:
QMS and Applicable Standards/Specifications (verify current
versions):
Audit Scope/Objective:
Facility Info Changes NoYes If yes, include changes on facility
info sheet
Actual Number of Employees:
Required Audit Days (Refer to timetable guidelines): Actual
Audit Days: Justification required if different from required audit
days
Justification (Notify API of changes):
Additional Comments:
Shifts:Start TimeEnd TimeNo. of EmployeesAudited? (Y/N)
Shift 1
Shift 2
Shift 3
Explanation (required for shifts not audited):
Additional Comments:
Number of Findings: Major (Systemic):Minor
(Isolated):Concerns:
Comments:
Audit Time Summary
DateStart TimeEnd TimeFacility Rep Initials
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
If audit duration is longer than 7 days, please add additional
daily start/stop time. Time spent auditing offsite or at other
locations, such as subcontractors, must be identified and noted in
the audit report.
Audit Summary
Strengths:
Opportunities for Improvement (OFIs):
Provide a summary of the closure and verification of corrective
actions for previous findings, if any:
Provide an overall assessment of the capability of the facility
to manufacture product(s) (Monogram):
Provide an overall assessment of the effectiveness of the
management system and the facilitys ability to perform activities /
provide products within the scope of registration:
Conclusion / Recommendation
Registration and / or Licensing are granted / continued /
reinstated based on satisfactory implementation of a Management
System and / or demonstrated capability to meet applicable
specification requirements with no nonconformities identified.
Registration and / or Licensing be granted / continued /
reinstated subject to the review of the nonconformance(s)
identified and acceptance of appropriate corrective action(s) by
the API Registration & Licensing Committee.
Registration and / or Licensing subject to the review of the
audit results and nonconformance(s) identified, acceptance of
appropriate corrective action(s) and additional actions as defined
by the API Registration & Licensing Committee. This decision
may include a re-audit to verify the required corrective actions,
withdrawal, suspension and or cancelation.
Note: Audits may result in suspension or cancellation of the
organizations license(s) and/or registration(s) or withdrawal of
application for licensing/registration. API makes the final
determination of certification status and shall be the sole judge
of whether licensing or registration will be granted/maintained.
You will be notified by API if your license/registration is
adversely affected by the results of this audit.
Final Auditor / Audit Team Remarks:
Organizations Representative Comments:
By signing below, I (we) attest that the information above is
accurate and has been collected by the audit team during the
performance of the audit that was assigned to me (us) by API and
that audit recommendations and conclusions were communicated to the
organization.
Audit Team Leader: Date:
Audit Team Member: Date:
Audit Team Member: Date:
By signing this document, it is not an admission of the
acceptance of any nonconformities/concerns identified by the audit
team. The signature only confirms that the audit was performed and
the audit recommendations and audit conclusions were communicated
by the auditor. API reserves the right to have final determination
of the level of nonconformity identified in the audit AARs and
final audit report.
Organization Representative (optional): Date:
Enter the next audit date for Dual/Registration Audits below
(Does not apply to Monogram only audits): First surveillance audit
after stage 2 initial audit MUST be scheduled 9 months after the
last day of the stage 2 audit Second / subsequent surveillance
audits around audit anniversary date of initial / first
surveillance audit Recertification audits at least 6 months prior
to the expiration dates
Next Audit Type: Next Audit Date:
Top of the Document
Opening / Closing Meeting Attendance Sheet
When performing the opening and closing meeting, please refer to
the Opening and Closing meeting guidelines
Facility ID: Audit ID:
Audit Team Leader:
Audit Team Members:
Audit Observer(s):
Opening Meeting (Day & Time):
Closing Meeting (Day & Time):
Participants (Name & Title) - Initial/check the meetings
attendedOpeningClosing
The information contained in this report is confidential and
subject to the confidentiality agreement between the Audit
Team/Auditor(s) and API. Details of the assessment results are
found in the succeeding pages of this report.
Findings Summary
Finding NumberN/C or ConcernProduct Impact
API Spec/ ClauseSummaryAuditor Initials
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
YesNo
Audit Report
Verification of Scope of Registration / Monogram License(s) and
Exclusions
Verify each of the following:Select One:Finding #:
Scope of registration is accurate for the activities and
processes performed by the facility.Yes
No If No, note all changes on the applicable QAR, as well as an
explanation for the changes
N/A No Certificates of Registration
Monogram Only - Product scope of Monogram License is accurate
for the activities and processes performed by the facility and
facility has the manufacturing capability for each product within
the scope of the license(s).Yes
No If No, Note all changes on the applicable QAR, as well as an
explanation for the changes
N/A No Monogram License(s)
Exclusions taken are allowable, applicable and justified.
Document any discrepancies.Note: Please see Advisory 6 for
allowable Monogram Program design exclusions.Exclusions are
Accurate and Appropriate
No Exclusions
Exclusions should be updated as follows:
Additional comments: No If No, note all changes on the
applicable QAR, as well as an explanation for the changes
Changes to the QMS since previous audit (if applicable):
Use of API Monogram, APIQR and ANAB Marks
A.5 Control of the Application of the API Monogram
Requirements:Objective Evidence / Comments:Finding #:
Verify the marking/monogramming procedure addresses all
requirements of Annex A.5.
Describe the licensees procedure for removal of the Monogram
from non-conforming product. Identify evidence of implementation,
if applicable.
AMA (Alternative Marking Agreement) if the facility has an AMA,
identify the marking facility and the controls established.
API Monogram Marks sampled (on products, letterhead, business
cards or any other medium): Note: The Monogram and License Number
must be used together at all times. They cannot be used on test
certificates, certificates of conformity, shipping documents,
etc.API Spec:Verify each of the following:
Product conforms to API-spec requirements
Applied by licensee only
Includes mark and license number
Applied to product at licensed facility location
Verify conformance of the following requirements for use of the
ANAB/APIQR mark. Any No selected is considered a nonconformance.
YesNoN/A
APIQR Marks are only on correspondence, advertising, and
promotional materials that are related to the goods and services
referenced in the scope of the Organizations registration.
The APIQR / ANAB Mark has not been used on a product or in such
a way as to suggest that APIQR / ANAB have certified or approved
any product, process or service of the registered organization.
The APIQR and ANAB Marks are used in conjunction with the
organizations name, location and registration certificate
numbers.
The ANAB Mark is used in conjunction with the APIQR Mark.
The APIQR and ANAB Marks are reproduced:1. in black, its
original colors or the predominant color of the letterhead or
printing, 2. on a clearly contrasting background, and 3. in a size
which makes the marks features clearly distinguishable, the length
of a side being in no case less than 12mm (APIQR Mark) and 10mm
(ANAB Mark).
Upon written notification, the organization immediately ceased
and desisted in the use of the APIQR/ANAB Marks and/or API Monogram
1) upon suspension or cancellation or 2) use in any manner, which
API/APIQR interprets as misleading.
Applicant organization APIQR, ANAB Marks and/or API Monogram
have not been identified in promotional materials or other company
documentation.
Additional comments:
Quality Management System Requirements
In the space provided below, detail the objective evidence
(documentation reviewed, records reviewed and personnel
interviewed) to ensure conformance with QMS requirements. Detail
any discrepancies / nonconformances identified.
Requirement:Objective Evidence/Comments: Finding #:
Verify that the organization has established, documented,
implemented and maintained a QMS for all servicing and products
provided for use in the petroleum and natural gas industry.
4.4.1 Quality Manual
Verify that the QM addresses the following requirements: Scope
of the QMS, including exclusions Interaction & sequence of
processes Processes that require validation Reference to documented
procedures that control the QMS
4.1.2 Quality Policy
Verify that the Quality Policy has been defined, documented and
approved as required and meets all requirements identified in the
applicable standard.
4.1.3 Quality Objectives
Verify that Quality Objectives are approved, documented, and
established at relevant functions and levels and are measurable and
consistent with the Quality Policy.
Verify KPIs are identified for use in Data Analysis.
4.1.4 Planning
Verify that management has ensured that: criteria and methods
needed for the operation and control of the QMS are determined,
managed and are effective planning of the QMS is carried out to
meet spec requirements
Communication Processes
Requirement:Objective Evidence/Comments: Finding #:
4.1.5.1 Internal Communication
Verify that the organization has established appropriate
communication processes and the effectiveness of the QMS is
communicated; and that processes established ensure that the
importance of meeting requirements and analysis of data is
communicated at relevant functions.
4.1.5.2 External Communication
Verify that the organization has established appropriate
communication with external customers to ensure that requirements
are understood, and that communication processes meet applicable
requirements of the standard.
Management Responsibility
Requirement:Objective Evidence/Comments: Finding #:
4.2.1 Resources
Describe how top management ensures availability of resources
essential to the QMS.
4.2.3 Management Representative
Identify the name of the organizations Management Representative
and roles / responsibilities.
Verify the following: Competence, training & awareness for
appointment; and Applicable responsibility and authority has been
granted.
Describe how the MR reports to management on the performance of
the QMS.
Documentation Requirements
4.4.2 Procedures
Verify that procedures required by the standard are established,
documented, implemented, and maintained for continual suitability.
(Please complete the Identification of QMS Procedures table.)
ClauseRequirementProcedure ID: Revision:Finding#:
4.3.2.2Competency
4.3.2.3Training
4.4.3Control of Documents
4.5Control of Records
5.1.1Review of Requirements
5.3Risk Assessment & Management
5.4.1Design & Development Planning
5.5Contingency Planning
5.6Purchasing
5.6.3Verification of Purchased Products or Activities
5.7.1.1Control of Production
5.7.1.2Control of Servicing
5.7.3Identification & Traceability
5.7.4Product Inspection/Test
5.7.5Customer-supplied Property
5.7.6Preservation of Product
5.7.7Inspection & Testing
5.7.8Preventive Maintenance
5.8Control of Testing, Measuring, & Monitoring Equipment
5.9Product Release
5.10Control of Nonconforming Product
6.2.1Customer Satisfaction
6.2.2Internal Audit
6.3Analysis of Data
6.4.2Corrective Action
6.4.3Preventive Action
Annex AMonogram Marking Note: Mark N/A if registration only
4.4.3 Control of Documents
Requirement:Objective Evidence/Comments: Finding #:
Describe how the facility controls documents required by the QMS
to ensure that relevant versions are used and maintained.
Describe how external documents are controlled to ensure that
relevant versions are used and maintained.
Describe how obsolete documents are identified / removed to
ensure against unintended use.
4.4.4 Use of External Documents in Product Realization
How does the facility ensure integration of external documents
into the product realization process or any other affected
process?Verify that product and other specific requirements are
integrated as required. Note: For Monogram Licensees/Applicants,
ensure that current versions of all applicable normative standards
are available
4.5 Control of Records
Requirement:Objective Evidence/Comments: Finding #:
Verify that the procedure meets all requirements of the
applicable standard and is controlled, implemented, and
maintained.
How does the facility identify, store, protect, retain, retrieve
and dispose of records?
Has the facility identified controls and responsibilities needed
to identify, collect, store, protect, retain, retrieve and dispose
of records?
Has the facility maintained records based on the required
retention times as specified in the applicable standard, product
spec, and / or the customer / QMS requirements?
QMS Monitoring, Measurement, Analysis, and Improvement
Requirements:Objective Evidence / Comments:Finding #:
Describe how the organization has planned and implemented the
monitoring, measurement, analysis, and improvement processes needed
to ensure conformity to requirements.
Verify that determination of applicable methods and the extent
of their use are included.
Management Review
Requirements:Objective Evidence / Comments:Finding #:
Identify date(s) of management reviews within the last 12-month
period. (Verify that management reviews are conducted at least
every 12 months.)
Verify that the management review has been documented with
sufficient evidence to demonstrate conformity with applicable
requirements. If no, note deficiencies.
6.5.2 Review Input - Verify that the management review includes
all inputs required by the applicable standard, including: Result
of audits Customer Feedback Results of Risk Assessment Status of CA
/ PA Supplier Performance Analysis Process Performance and Product
Conformity Changes that could affect the MS Recommendations for
Improvement
6.5.3 Review Output - Verify that the management review output
includes a summary assessment of the effectiveness of the MS
detailing any: Required changes to the processes Decisions and
actions Required resources Improvement for products
Analysis of Data
Requirements:Objective Evidence / Comments:
What data have been determined, collected and analyzed to
demonstrate the suitability and effectiveness of the QMS? [Such
data analysis may be related to quality objectives and result in
modifications to these objectives, number of nonconforming product,
etc.]
Data TypesAnalysis MethodReported
HowFrequencyObjective / KPI
Customer Satisfaction
Supplier Performance
Product Conformity
Nonconformities / product failures after delivery / use
Process trends and characteristics
Opportunities for Preventive Action
Quality Objectives
Internal Audit
Process Evaluation
Requirements:Objective Evidence / Comments:Finding #:
What methods are applied for monitoring (and measuring) QMS
processes? These methods shall demonstrate the ability of the
processes to achieve planned results.
When planned results are not achieved, what actions are taken to
ensure conformity of the product? Identify examples.
Internal Audits
Requirements:Objective Evidence / Comments:Finding #:
Identify the date the last internal audit was completed. Verify
that the audit was performed within 12 months from the previous
internal audit (if applicable). Note: API interprets Last Internal
Audit to mean the last complete audit of the ENTIRE QMS, whether
performed at one time or over the period of 12 months.
Did internal audit planning take into account results of
previous audits and criticality of the process being audited?
Verify that the internal audit performed: conforms to planned
arrangements including the requirements of the applicable standard
/ specification; has been effectively implemented and maintained,
including records; was performed by independent / objective,
competent personnel; include outsourced activities that impact the
quality of the product and that are performed at the facility; and
includes all processes required by the MS required to meet the
applicable standard / specification
Describe how the organization addresses nonconformances
identified during the internal audit (e.g., response times,
responsibilities, reporting, and records).
Improvement Processes Corrective / Preventive Action
6.4.2 Corrective Action
Requirements:Objective Evidence / Comments:Finding #:
What actions are taken by the organization to eliminate the
cause of nonconformities? Actions should include: reviewing
nonconformities determining cause of nonconformities evaluating
action to prevent recurrence determining/implementing action needed
recording of results reviewing corrective action taken
Describe how corrective actions are verified for effectiveness.
What records are available as evidence of verification?
How are corrective actions initiated? How are response times for
addressing corrective actions tracked?
6.4.3 Preventive Action
Requirements:Objective Evidence / Comments:Finding #:
What actions are taken by the organization to minimize the
likelihood of potential nonconformities? Actions should include:
determining potential nonconformities and their cause evaluating
action to prevent occurrence determining/implementing action needed
recording of results reviewing preventive action taken.
Product Realization
Audit Conditions
1. The audit must determine the degree to which products are
being manufactured under the scope of the applicable API Monogram
License(s) and / or Registered QMS. 2. Determine the availability
of the products for review and audit processes in conjunction with
these products. 3. It is intended that this be completed prior to
the audit as part of the planning process. In cases where pre-audit
information is not available this MUST be done during the opening
meeting/facility tour.4. Please include as many products as
possible that are included as part of the scope of Licensing /
Registration.5. Priority should be established at the start of the
audit to verify manufacturing according to the conditions outlined
below.
CategoryCategory Definition
1Monogram product currently being manufactured and available for
review
2Monogrammable (product meeting all requirements but not marked)
product currently being manufactured and available for review
3Non-monogrammable product currently being manufactured and
available for review
4Monogram product manufactured since the last API audit but not
available for review (records review)
5Monogrammable product manufactured since the last API audit but
not available for review (records review)
6Non-monogrammable product manufactured since the last API
audit
7For dual & registration clients Product currently being
manufactured or services currently being provided that fall under
the scope of the registered quality management system.
NOTE 1: Please refer to API Spec Q1, Annex A, A.4 regarding the
requirement for a Licensee to develop, maintain and operate at all
times a QMS conforming to API Spec Q1NOTE 2: Please identify any
products that are being added to the scope of Licensing and / or
Registration, including products that are new and have been added
since the last audit. These products must be considered when
sampling objective evidence during the audit.
Complete the table below based on the above classifications:
CategoryProduct/Service IdentificationSpecification (as
applicable)
Planning
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) :Check
each requirement upon verification (explanation must be given for
any blank boxes):
Organizational Capability Provision of Resources (4.3.1)Describe
how the organization determines and allocates the required
resources for the QMS, services, and activities performed:
The organization determines and allocates resources needed to
implement maintain and improve the effectiveness of the QMS
Planning (5.2)
Planning of product realization:
Consistent with QMS process
Required resources / work environment (4.3)
Product / customer requirement (5.1)
Legal / other applicable requirements
Contingencies based on risk assessment (5.3, 5.5)
Design and development requirements (5.4)
Required verification, validation, monitoring, measuring,
inspection, test activities
MOC (5.11)
Records maintained
Output of product realization planning:
Output documented
Plans updated as changes occur
Plans maintained suitably
Contract Review / Customer Related Processes
List all Contracts reviewed / sampled (minimum of 3 include
contract identification, customer name, date of contract and any
other pertinent details below): NOTE: Sampling must consider range
of products with Licensing / QMS scope and sample must be increased
based on number of products within scope, volume of work, etc.API
Spec / Product:
Determination of Product Requirements (5.1.2)
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) : Check
each requirement upon verification (explanation must be given for
any blank boxes):
Determination of requirements: Customer Requirements
Legal / other applicable requirements
Requirements not stated by customer
Also verify: Requirements confirmed and records maintained where
no requirements are stated/documented by customer
Review of Product Requirements(5.1.3)Review of requirements:
Reviewed prior to commitment
Requirements identified and documented
Capability confirmed
Records maintained
Changes to Requirements(5.1.3)
Changes to contract requirements:
Documents amended
Changes communicated
External Communications(4.1.5.2)
Approval process determined, documented, and implemented
Requirements are fully understood
Customer Satisfaction(6.2.1)
Methods for obtaining / using customer information
Risk Assessment & Management
Requirements:Objective Evidence / Comments:Finding #:
Verify the RM process has been established to identify and
control risks associated with: impact on delivery, including
facility/equipment availability, maintenance and supplier
performance and material availability/supply; quality of product,
including delivery of nonconforming product & availability of
competent personnel.
Describe the tools, techniques and their application for risk
identification, assessment and mitigation utilized by the
organization.
Identify process interaction / examples of Risk Assessment &
Management implementation and tools / techniques used: Check each
requirement upon verification (explanation must be given for any
blank boxes):
Risks Identified
Contingency Planning
Requirements:Objective Evidence / Comments:Finding #:
Verify that contingency planning is based on assessed risks
(5.3).
Verify that the output of contingency planning is documented,
updated and communicated as required.
Identify process interaction / examples of Contingency Planning
implementation: Check each requirement upon verification
(explanation must be given for any blank boxes):
Based on assessed risks
Output documented / updated as required
Output communicated
Records maintained
Design & Development
Select all that apply:
Performed in-house
Performed at a different location within the same
organization
Outsourced
Excluded; Justification confirmed (per API Advisory 6)
List design packages sampled / verified: (Select a
representative sampling (minimum of three) of the applicable
products (per API Specifications or Registration Scope) Any license
in application status requires verification of all product designs
within that specification. Any product additions to existing
licenses must have evidence of existing designs. Please incorporate
and complete the relevant Product Spec Audit Questions It may not
be sufficient for the Licensee/applicant to have only 1 package
that covers a product. Separate packages may be required / sampled
based on different sizes, pressure ratings, etc.API Product
Spec:
Design Package Requirements (Annex A, A.6 Monogram Only)Verify
that the licensee / applicant has a design package for each product
under the scope of each Monogram License
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) :Check
each requirement upon verification (explanation must be given for
any blank boxes):
Design & Development Controls In-house / different location
within same organization (5.4.1, 5.4.2, 5.4.3, 5.4.4, 5.4.5, 5.4.6,
5.4.7)Design & Development Planning:
Planning as per 5.4.1
Design plan updated
Effective communication
Design acceptance criteria
Design & Development Inputs:
API Spec requirements included (when applicable)
Inputs per 5.4.2
Records Maintained
Also verify: - Customer requirements (5.1) - Results from risk
assessment (5.3)- Requirements from external sources
Design & Development Outputs:
Output as per 5.4.3
Records Maintained
Also verify: - DAC identified / referenced- Critical
products/components identified / referenced
Design & Development Review:
Review as per 5.4.4
Records Maintained
Design & Development Final Review & Verification:
Verification and Final Review as per 5.4.5
Conducted / documented per planned arrangement (5.4.1)
Records Maintained
Design & Development Validation & Approval:
Validation and Approval as per 5.4.6
Records Maintained
Design & Development Changes:
Changes as per 5.4.7
Records Maintained
Design & Development Controls Outsourced (5.4.1)Suppliers
Competency and Control of Outsourced Design:
Personnel Competence
Records Maintained
Also verify: - Resources, responsibilities, authorities and
their interfaces- Suppliers control, when design activities are
outsourced
Purchasing
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed):Check each
requirement upon verification (explanation must be given for any
blank boxes):
Purchasing Controls(5.6.1)Control of Purchasing:
Criticality of activities/products determined
Type and extent of control defined on criticality
Criteria, scope, frequency and methods of reassessment
defined
List of approved suppliers and scope of approval
5.6.1.2 Critical Suppliers Evaluation and Reevaluation (5.6.1.4,
5.6.1.5)
Critical Suppliers Sampled: Product / Component / Activity
Performed:Check each requirement upon verification (explanation
must be given for any blank boxes):
Site specific criteria
Reevaluation per 5.6.1.3
Records Maintained 5.6.1.5
Also verify: Risk assessment associated with product delivery
includes supplier performance. Ensure risks are identified and
controlled (5.3b).
5.6.1.3 Non-Critical Suppliers Evaluation and Reevaluation
(5.6.1.4, 5.6.1.5)
Non - Critical Suppliers Sampled: Product / Component / Activity
Performed:Check each requirement upon verification (explanation
must be given for any blank boxes):
Initial and on-going capability assessment per 5.6.1.3
Records Maintained 5.6.1.5
Also verify: Risk assessment associated with product delivery
includes supplier performance. Ensure risks are identified and
controlled (5.3b).
5.6.1.6 Outsourced Activities
List all outsourced activities and processes (if
applicable):
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) :Check
each requirement upon verification (explanation must be given for
any blank boxes):
5.6.1.6 Outsourced ActivitiesControl of outsourced
activities:
Records Maintained
Organizations applicable QMS requirements satisfied
Also verify:Organization maintains responsibility for product
conformance to specified requirements including API Spec
Purchasing Information (5.6.2)Purchasing Information (include
contracts/POs sampled -minimum of 3 :
Acceptance criteria documented
Records Maintained
Also verify: Documented requirements per 5.6.2(a)(b)(c)(d),
where applicable
Verification of Purchased Product / Activities
(5.6.3)Verification of conformance to purchase requirements
(include records reviewed as evidence of conformance):
Records Maintained
Also verify: - Controls for verification at suppliers premises,
where applicable
Product Quality Plan(s) (as applicable)
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) : Check
each requirement upon verification (explanation must be given for
any blank boxes):
Product Quality Plans (if required)(5.7.2)Quality Plans
sampled:
Addresses each requirement of 5.7.2 (a) through (e)
Revisions documented / approved
Communicated
Production and Servicing Processes
Description of Production / Servicing Capabilities [What
capabilities does the facility have (i.e., what are they capable of
manufacturing?)] Reference all monogrammable and non-monogrammable
products:
Description of Production and/or Servicing Processes (describe
what manufacturing/servicing processes actually take place at the
facility and interactions): Processes must be described in specific
detail to provide information regarding the capabilities of the
facility being audited. For example, production processes must be
identified clearly as machining, assembly, welding, heat treatment,
etc.; testing processes must be identified clearly as
hydro-testing, nondestructive examination, etc.
Production / Servicing Processes reviewed/sampled:
Process (Area):Personnel interviewed and position/title:PO / WO
number:Description of product/ service/part:Product/service/ part
identified?Inspection status identified?Process control documents
(verify revision):
Control of Production (5.7.1.1)Detail evidence observed
(including records and documents reviewed, personnel interviewed,
and processes observed) : Check each requirement upon verification
(explanation must be given for any blank boxes):
Controls established and implemented for production:
Procedure as per 5.7.1.1
Design requirements/changes
Suitable equipment
Process control documents
Also verify: Implementation of Quality Plan, if required Work
instructions, when applicable Monitoring & measuring activities
Product release activities
Control of Servicing (if applicable)(5.7.1.2)Controls
established and implemented for servicing:
Procedure as per 5.7.1.2
Review of requirements
Suitable equipment
Identification/traceability
Process control documents
Also verify: Work instructions, when applicable Monitoring &
measuring activities Requirements for release of serviced
product
Process Control Documents(5.7.1.3)
Documentation of process controls:
Includes requirements for verifying conformance with quality
plans, product specs, customer requirements
Reference instructions
Acceptance criteria
Also verify: Inspection holds and witness points
Product Realization Capability Documents(5.7.1.4)Product
realization documentation sampled:
Product realization plan (5.2)
Records of review/verification, validation, monitoring,
measurement, inspection, tests
Acceptance criteria demonstrating capability
Validation of Processes for Production and
Servicing(5.7.1.5)Validation of processes for production and
services (including outsourced):
Demonstrates ability to achieve planned results
Verification of supplier conformance to standard requirements
(5.6.1.6)
Records maintained
Records reviewed for processes requiring validation (select all
that apply; enter additional records reviewed):
NDEWeldingHeat TreatmentOther:
Personnel QualificationWPSPersonnel Qualification
Equipment QualificationPQRProcedure/WIs
Work EnvironmentWPQFurnace Surveys
Procedure QualificationWelder Continuity Log
Personnel Qualifications
Equipment Qualification
Organizational Capability Work Environment (4.3.3)
Requirement:Objective Evidence/Comments: Finding #:
Describe the work environment, including buildings, workspace
and utilities; process equipment; supporting services; conditions
under which work is performed.
Verify that the organization has determined, provided, manages,
and maintains the work environment needed to achieve conformity
applicable to the manufacture of the product(s).
Verify risk assessment associated with product delivery includes
facility/equipment availability and maintenance. Ensure risks are
identified and controlled (5.3a).
Identification and Traceability
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) : Check
each requirement upon verification (explanation must be given for
any blank boxes):
Identification/ Traceability (5.7.3)
Identification / traceability reviewed / sampled:
Records maintained
Also verify :- Delivery and post-delivery- Maintenance /
replacement of identification / marks
Product Inspection / Test Status
Product Inspection / Test Status(5.7.4)
Records maintained indicating conformity / nonconformity of
product
Customer-supplied Property (if applicable)
Customer-supplied Property (5.7.5)(if applicable)
Procedure per 5.7.5
Records maintained
Also verify:Requirements for reporting to customer
Preservation of Product
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) : Check
each requirement upon verification (explanation must be given for
any blank boxes):
Preservation of Product (5.7.6.1)
Identification / traceability marks
Transportation, handling, packaging and protection
Records maintained
Storage and Assessment (5.7.6.2)
Designated storage area / stock rooms
Records of assessment maintained
Preventive Maintenance
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) : Check
each requirement upon verification (explanation must be given for
any blank boxes):
Preventive Maintenance (5.7.8)Preventive maintenance for
equipment used in product realization:
Procedure as per 5.7.8
Type of equipment, frequency, responsible personnel
identified
Records maintained
Inspection and Testing
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) : For
Monogram only, ensure that all inspection and testing requirements
of the applicable product specification are addressed For Monogram
only, please incorporate and complete the relevant Product Spec
Audit QuestionsCheck each requirement upon verification
(explanation must be given for any blank boxes):
Inspection and Testing (5.7.7)In-process inspection and
testing:
Procedure as per 5.7.7.1
Inspection / testing at planned stages per plan / procedure
Evidence of conformity with acceptance criteria maintained
Final inspection and testing:
Procedure as per 5.7.7.2
Final inspection / testing per plan / procedures
Evidence of conformity to requirements maintained
Product Release
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) : Check
each requirement upon verification (explanation must be given for
any blank boxes):
Product Release(5.9)
Procedure as per 5.9
Release upon satisfactory completion of planned arrangements
Also verify:Approval of release by authority/customer when
planned arrangements are not met
Control of Testing, Monitoring and Measuring Equipment
Requirements:Objective Evidence / Comments:Finding #:
Verify that the organization has determined the testing,
monitoring, and measurement requirements and the associated
equipment needed to ensure conformance.
Describe controls established and implemented to ensure that
equipment is identified, calibrated, maintained, and used in a
manner consistent with requirements. Also verify: Control of out-of
tolerance equipment and assessment of previous measurements.
Equipment observed / sampled (minimum of 3):Note: For Monogram
only, ensure that all inspection and testing requirements of the
applicable product specification are addressedCheck each
requirement upon verification (explanation must be given for any
blank boxes):
Equipment:Description:Cal Date:Due Date:Uniquely identified
Calibration status identified
Traceable to Natl/intl standard
Included on registry
Acceptance criteria defined and appropriate
Records maintained
Also verify: - Computer software confirmation- Externally
provided equipment
Control of Nonconforming Product
Detail evidence observed (including records and documents
reviewed, personnel interviewed, and processes observed) : Check
each requirement upon verification (explanation must be given for
any blank boxes):
Control of Nonconforming Product (5.10)
Procedure as per 5.10.1
Method of addressing non-conforming product per 5.10.2
Concession approved by relevant authority and/or customer
Customer notification per 5.10.4
Records maintained (5.10.5)
Also verify: Proper identification to prevent unintended use-
Addressing the nonconformity- Identification, documentation,
analysis and actions taken for nonconforming product identified
after delivery- Risk assessment includes supplier performance.
Ensure risks are identified and controlled (5.3b).
Management of Change
Requirements:Objective Evidence / Comments:Finding #:
Describe the MOC process established by the facility. Verify
that the MOC process has been established to ensure that integrity
of the MS when changes are planned and implemented.
How does the facility identify potential risks associated with
changes prior to making the change?
Verify that changes are approved as required prior to making
changes.
Describe how the facility ensures that the MOC process is used
for changes that may affect the QMS negatively, including changes:
to the organizational structure; in key or essential personnel; in
critical suppliers; and to MS processes, including changes
resultingfrom CA / PA
Describe the organizations process for notification of changes.
When is notification required? To who is notification required?
Identify process interaction / examples of Management of Change
implementation: Check each requirement upon verification
(explanation must be given for any blank boxes):
Negative affect(s) on QMS identified
Risks identified prior to change
Approved prior to change
Notification of change
Records maintained
Human Resources / Competence / Training Processes
Requirement:Objective Evidence/Comments: Finding #:
4.2.2 Responsibility and Authority
Describe how responsibilities, authorities, and accountabilities
are defined, documented, assigned within and communicated
throughout the organization.
4.3.2.2 Personnel Competence
How does the organization determine the necessary competence for
personnel performing work affecting product quality?
Verify risk assessment associated with product quality includes
the availability of competent personnel. Ensure risks are
identified and controlled (5.3c).
4.3.2.3 Training and Awareness
Verify that the organization: provides for QMS training and job
training; includes customer-specified and/or customer-provided
training; identifies the frequency and content of training; ensure
personnel are aware of the relevance and importance of their
activities and how they contribute to the achievements of the
quality objectives; and maintains appropriate records.
How does the facility identify training needs and ensure that
personnel receive adequate training to address competency needs.
What other methods has the facility used to address competency
needs (outsourcing, process changes, etc.)?
Describe how the effectiveness of the actions are evaluated and
maintained (i.e., competence evaluation) to ensure requirements are
met.
Personnel Sampled for Competency and Training
NameTitleCompetency Defined / Record EvidencedTraining Record /
Record EvidencedFinding#:
Supplemental Audit Information
Enter additional information relevant to the audit, if
necessary; please include process(es) audited/verified:
Audit Package Checklist
Facility Information Sheet**Product Questions*Stage 1 Audit
Report*
QAR(s)**Findings (AARs)*Audit Plan
* If required**Please update as necessary
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