API's 9th Internal Audit Form

Audit Report
Doc ID: FM-198.Q1

Revision: 1.0
Effective Date: 5/30/2014
Contents
Audit Information....................................................................................................................................... 2
Audit Time Summary................................................................................................................................. 3
Audit Summary.......................................................................................................................................... 3
Conclusion / Recommendation................................................................................................................ 4
Opening / Closing Meeting Attendance Sheet........................................................................................ 5
Findings Summary.................................................................................................................................... 6
Audit Report............................................................................................................................................... 7
Verification of Scope of Registration / Monogram License(s) and Exclusions..........................................7
Use of API Monogram, APIQR and ANAB Marks.....................................................................................8
Quality Management System Requirements............................................................................................ 9
Communication Processes.................................................................................................................... 10
Management Responsibility................................................................................................................... 10
Documentation Requirements................................................................................................................ 11
QMS Monitoring, Measurement, Analysis, and Improvement................................................................13
Management Review......................................................................................................................... 13
Analysis of Data................................................................................................................................. 14
Process Evaluation............................................................................................................................ 14
Internal Audits.................................................................................................................................... 14
Improvement Processes Corrective / Preventive Action......................................................................15
Product Realization................................................................................................................................ 16
Audit Conditions................................................................................................................................. 16
Planning............................................................................................................................................. 17
Contract Review / Customer Related Processes...............................................................................18
Risk Assessment & Management...................................................................................................... 19
Contingency Planning........................................................................................................................ 19
Design & Development...................................................................................................................... 20
Purchasing......................................................................................................................................... 22
Product Quality Plan(s) (as applicable).............................................................................................. 23
Production and Servicing Processes...................................................................................................... 24
Product Release..................................................................................................................................... 28
Control of Testing, Monitoring and Measuring Equipment......................................................................29
Control of Nonconforming Product......................................................................................................... 29
Management of Change......................................................................................................................... 30
Human Resources / Competence / Training Processes.........................................................................30
Supplemental Audit Information............................................................................................................ 32
Audit Package Checklist......................................................................................................................... 32
#Top of the Document
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Audit Report
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.):
API Spec Q1
ISO 9001
Audit Criteria:
API Spec Q2
ISO 14001
OHSAS 18001
API Spec(s) (list all applicable specifications):

Other criteria:
QMS and Applicable

Standards/Specifications
(verify current versions):
Audit Scope/Objective:
Facility Info Changes
No
Yes If yes, include changes on facility info sheet
Actual Number of
Employees:
Required Audit Days (Refer
to timetable guidelines):
Justification
(Notify API of changes):
Additional Comments:
Shifts:
Actual Audit
Days:
Start Time
Justification required if different from required audit

days
End Time
No. of Employees
Audited? (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:
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Audit Time Summary

Date
Start Time
End Time
Facility 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:
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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 o
application for licensing/registration. API makes the final determination of certification status and shall be the sole judge o
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:

Audit Team Member:
Audit Team Member:
Date:
Date:
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:
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Audit Report
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 attended
Opening
Closing
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.
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Audit Report
Finding
Number
N/C or
Concern
Product Impact
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Findings Summary
API
Spec/
Clause
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Audito
Initials
Summary
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Yes
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No
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Audit Report
Verification of Scope of Registration / Monogram License(s) and Exclusions
Verify each of the following:
Select One:
Finding #:
Yes
Scope of registration is accurate for the activities
and processes performed by the facility.
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
Exclusions taken are allowable, applicable and

justified. Document any discrepancies.
Note: Please see Advisory 6 for allowable Monogram
Program design exclusions.
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 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):
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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):
API
Spec:
Verify each of the following:
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.
Product conforms to APIspec 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.
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.
2.
3.
Yes
No
in black, its original colors or the predominant color of the letterhead or printing,
on a clearly contrasting background, and
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:
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N/A
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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.
Finding #:
Requirement:
Objective Evidence/Comments:
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
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Communication Processes
Requirement:
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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:
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.
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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.)
Clause
4.3.2.2
4.3.2.3
4.4.3
4.5
5.1.1
5.3
5.4.1
5.5
5.6
5.6.3
5.7.1.1
5.7.1.2
5.7.3
5.7.4
5.7.5
5.7.6
5.7.7
5.7.8
5.8
5.9
5.10
6.2.1
6.2.2
6.3
6.4.2
6.4.3
Annex A
Requirement
Competency
Training
Control of Documents
Control of Records
Review of Requirements
Risk Assessment & Management
Design & Development Planning
Contingency Planning
Purchasing
Verification of Purchased Products or
Activities
Control of Production
Control of Servicing
Identification & Traceability
Product Inspection/Test
Customer-supplied Property
Preservation of Product
Inspection & Testing
Preventive Maintenance
Control of Testing, Measuring, &
Monitoring Equipment
Product Release
Control of Nonconforming Product
Customer Satisfaction
Internal Audit
Analysis of Data
Corrective Action
Preventive Action
Monogram Marking
Procedure ID:
Revision:
Finding#:
Note: Mark N/A if registration only
4.4.3 Control of Documents

Requirement:
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
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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:
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:
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
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the extent of their use are included.
Management Review
Requirements:
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:
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 Types
Analysis Method
Reported
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Audit Report
How
Frequency
Objective / 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:
Finding
#:
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:
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?
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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:
Finding #:
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:
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.
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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.
Category
Category Definition
1
2
3
4
5
6
7
Monogram product currently being manufactured and available for review

Monogrammable (product meeting all requirements but not marked) product currently being
manufactured and available for review
Non-monogrammable product currently being manufactured and available for review
Monogram product manufactured since the last API audit but not available for review (records review)
Monogrammable product manufactured since the last API audit but not available for review (records
review)
Non-monogrammable product manufactured since the last API audit
For 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 Q1
NOTE 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:

Category
Product/Service Identification
Specification (as applicable)
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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):
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 of product realization:
Consistent with QMS process
Organizational
Capability
Provision of
Resources
(4.3.1)
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
Planning
(5.2)
MOC (5.11)
Records maintained
Output of product realization planning:
Output documented
Plans updated as changes
occur
Plans maintained suitably
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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):
API Spec / Product:
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.
Detail evidence observed (including records and documents

reviewed, personnel interviewed, and processes observed) :
Determination of
Product
Requirements
(5.1.2)
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 requirements:
Review of
Product
Requirements
(5.1.3)
Changes to
Requirements
Reviewed prior to
commitment
Requirements identified and
documented
Capability confirmed
Records maintained
Changes to contract requirements:
Documents amended
Changes communicated
(5.1.3)
External
Communications
(4.1.5.2)
Customer
Satisfaction
(6.2.1)
Approval process
determined, documented,
and implemented
Requirements are fully
understood
Methods for obtaining / using
customer information
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Risk Assessment & Management

Requirements:
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:

Risks Identified
Contingency Planning
Requirements:
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:

Based on assessed risks
Output documented / updated
as required
Output communicated
Records maintained
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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.
Design
Package
Requirements
API Product Spec:
Verify that the licensee / applicant has a design package for each product under the scope of each
Monogram License
(Annex A, A.6
Monogram
Only)

Design & Development Planning:
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)

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
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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
Suppliers Competency and Control of Outsourced Design:

Design &
Development
Controls
Outsourced
(5.4.1)
Personnel Competence
Records Maintained
Also verify:
Resources, responsibilities, authorities

and their interfaces
- Suppliers control, when design activities

are outsourced
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Purchasing
interviewed, and processes observed):
Control of Purchasing:

Criticality of activities/products
determined
Type and extent of control
defined on criticality
Purchasing
Controls
(5.6.1)
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:

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:

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):
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Control of outsourced activities:
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Records Maintained
Organizations applicable QMS
requirements satisfied
5.6.1.6
Outsourced
Activities
Also verify:
Organization maintains responsibility for
product conformance to specified
requirements including API Spec
Purchasing Information (include contracts/POs sampled -minimum of 3 :

Acceptance criteria
documented
Purchasing
Information
(5.6.2)
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)

Quality Plans sampled:
Product
Quality
Plans (if
required)
(5.7.2)

verification (explanation must be given
for any blank boxes):
Addresses each requirement of
5.7.2 (a) through (e)
Revisions documented /
approved
Communicated
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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):

Procedure as per 5.7.1.1
Detail evidence observed (including records and documents

reviewed, personnel interviewed, and processes observed) :
Controls established and implemented for production:
Design requirements/changes
Suitable equipment
Control of
Production
(5.7.1.1)
Process control documents

Also verify:
-
Control of
Implementation of Quality Plan, if required

Work instructions, when applicable
Monitoring & measuring activities
Product release activities

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Controls established and implemented for servicing:
Review of requirements
Suitable equipment
Identification/traceability
Process control documents
Servicing (if
applicable)
(5.7.1.2)
Also verify:
- Work instructions, when applicable
- Monitoring & measuring activities
- Requirements for release of serviced product
Documentation of process controls:
Includes requirements for verifying

conformance with quality plans,
product specs, customer
requirements
Process
Control
Documents
(5.7.1.3)
Reference instructions
Acceptance criteria
Also verify:
Inspection holds and witness points
Product realization documentation sampled:
Product realization plan (5.2)
Product
Realization
Capability
Documents
(5.7.1.4)
Validation of
Processes
for
Production
and
Servicing
(5.7.1.5)
Records of review/verification,
validation, monitoring,
measurement, inspection, tests
Acceptance criteria demonstrating
capability
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):
NDE
Welding
Heat Treatment
Other:
Personnel Qualification
WPS
Personnel Qualification
Equipment Qualification
PQR
Procedure/WIs
Work Environment
WPQ
Furnace Surveys
Procedure Qualification
Welder Continuity Log

Personnel Qualifications
Equipment Qualification
Organizational Capability Work Environment (4.3.3)

Requirement:
Finding
#:
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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
Identification / traceability reviewed / sampled:
Identification/
Traceability
(5.7.3)

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)

Customersupplied
Property
(5.7.5)
(if
applicable)
Preservation of Product
Procedure per 5.7.5

Records maintained
Also verify:
Requirements for reporting to customer

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Identification / traceability marks
Transportation, handling,
packaging and protection
Records maintained
Preservation
of Product
(5.7.6.1)
Designated storage area / stock

rooms
Records of assessment
maintained
Storage and
Assessment
(5.7.6.2)
Preventive Maintenance
Preventive maintenance for equipment used in product realization:

Procedure as per 5.7.8
Type of equipment, frequency,
responsible personnel identified
Preventive
Maintenance
(5.7.8)
Inspection and Testing

Records maintained

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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 Questions
In-process inspection and testing:

Inspection / testing at planned
stages per plan / procedure
Evidence of conformity with
acceptance criteria maintained
Inspection
and Testing
(5.7.7)
Final inspection and testing:

Final inspection / testing per plan
/ procedures
Evidence of conformity to
requirements maintained
Product Release

Procedure as per 5.9
Product
Release
(5.9)
Control of Testing, Monitoring and Measuring Equipment

Requirements:
Release upon satisfactory

completion of planned
arrangements
Also verify:
Approval of release by authority/customer
when planned arrangements are not met
Finding #:
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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 addressed
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


verification (explanation must be given for
any blank boxes):
Procedure as per 5.10.1
Method of addressing nonconforming product per 5.10.2
Concession approved by relevant
authority and/or customer
Control of
Nonconfor
ming
Product
(5.10)
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:
Finding
#:
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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 resulting
from 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:

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:
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?
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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 customerprovided 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
Name
Title
Competency Defined /
Record Evidenced
Training Record /
Finding#:
Record Evidenced
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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
Page 33 of 33

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Audit Report

Doc ID: FM-198.Q1

#Top of the Document

Doc ID: FM-198.Q1

Audit Start Date:

Audit End Date:

Audit Type (Initial,

API Spec(s) (list all applicable specifications):

QMS and Applicable

Yes If yes, include changes on facility info sheet

Justification required if different from required audit

#Top of the Document

Doc ID: FM-198.Q1

Audit Time Summary

Facility Rep Initials

Opportunities for Improvement (OFIs):

#Top of the Document

Doc ID: FM-198.Q1

Organizations Representative Comments:

Audit Team Leader:

Organization Representative (optional):

#Top of the Document

Next Audit Date:

Doc ID: FM-198.Q1

Top of the Document

Opening / Closing Meeting Attendance Sheet

Audit Team Leader:

#Top of the Document

#Top of the Document

Doc ID: FM-198.Q1

#Top of the Document

Doc ID: FM-198.Q1

Doc ID: FM-198.Q1

No If No, note all changes on the applicable QAR,

Monogram Only - Product scope of Monogram

Exclusions taken are allowable, applicable and

No If No, Note all changes on the applicable QAR,

Changes to the QMS since previous audit (if applicable):

#Top of the Document

Doc ID: FM-198.Q1

Objective Evidence / Comments:

Verify the marking/monogramming procedure

Verify each of the following:

#Top of the Document

Doc ID: FM-198.Q1

Quality Management System Requirements

#Top of the Document

Doc ID: FM-198.Q1

4.1.5.1 Internal Communication

#Top of the Document

Doc ID: FM-198.Q1

Note: Mark N/A if registration only

4.4.3 Control of Documents

Describe how the facility controls documents

Doc ID: FM-198.Q1

4.5 Control of Records

Verify that the procedure meets all requirements

QMS Monitoring, Measurement, Analysis, and Improvement

Objective Evidence / Comments:

Describe how the organization has planned and

Doc ID: FM-198.Q1

Objective Evidence / Comments: