Doc ID: FM-198.

Q1
Revision: 1.0
Audit Report 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

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 Doc ID: FM-198.Q1
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Audit Information
Audit ID:
Facility ID:

Facility Name:
Lead Auditor:

Audit Team Members:

Audit Start Date: Audit End Date:

Audit Type (Initial,
Surveillance, Re-audit, etc.):
API Spec Q1 API Spec Q2 OHSAS 18001
ISO 9001 ISO 14001
Audit Criteria: 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 Actual Audit Justification required if different from required audit
to timetable guidelines): Days: days
Justification
(Notify API of changes):
Additional Comments:
Start Time End Time No. of Employees Audited? (Y/N)
Shifts:
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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 Doc ID: FM-198.Q1
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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 facility’s ability to perform activities /
provide products within the scope of registration:

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 Doc ID: FM-198.Q1
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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 organization’s 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:

Organization’s 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:

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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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Findings Summary
API
Finding N/C or Product Impact Auditor
Spec/ Summary
Number Concern Initials
Clause

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

Yes 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 No – If No, note all changes on the applicable QAR,
and processes performed by the facility. as well as an explanation for the changes
N/A – No Certificates of Registration

Monogram Only - Product scope of Monogram Yes

License is accurate for the activities and
No – If No, Note all changes on the applicable QAR,
processes performed by the facility and facility
as well as an explanation for the changes
has the manufacturing capability for each product
within the scope of the license(s). N/A – No Monogram License(s)

Exclusions are Accurate and Appropriate

Exclusions taken are allowable, applicable and
justified. Document any discrepancies. No Exclusions
Note: Please see Advisory 6 for allowable Monogram
Program design 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 licensee’s 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 API Verify each of the following:
other medium): Spec:
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 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.
Yes No N/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 Organization’s 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 organization’s 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 mark’s 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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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

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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 organization’s
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 Requirement Procedure ID: Revision: Finding#:

4.3.2.2 Competency
4.3.2.3 Training
4.4.3 Control of Documents
4.5 Control of Records
5.1.1 Review of Requirements
5.3 Risk Assessment & Management
5.4.1 Design & Development Planning
5.5 Contingency Planning
5.6 Purchasing
Verification of Purchased Products or
5.6.3
Activities
5.7.1.1 Control of Production
5.7.1.2 Control of Servicing
5.7.3 Identification & Traceability
5.7.4 Product Inspection/Test
5.7.5 Customer-supplied Property
5.7.6 Preservation of Product
5.7.7 Inspection & Testing
5.7.8 Preventive Maintenance
Control of Testing, Measuring, &
5.8
Monitoring Equipment
5.9 Product Release
5.10 Control of Nonconforming Product
6.2.1 Customer Satisfaction
6.2.2 Internal Audit
6.3 Analysis of Data
6.4.2 Corrective Action
6.4.3 Preventive Action
Monogram Marking
Annex A
Note: Mark N/A if registration only

4.4.3 Control of Documents

Requirement: Objective Evidence/Comments: Finding #:

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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?

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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
Finding #:
Requirements: Objective Evidence / Comments:
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

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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.]
Reported
Data Types Analysis Method
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: 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?

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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
Finding #:
Requirements: Objective Evidence / Comments:

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.

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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 Monogram product currently being manufactured and available for review
Monogrammable (product meeting all requirements but not marked) product currently being
2
manufactured and available for review
3 Non-monogrammable product currently being manufactured and available for review
4 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
5
review)
6 Non-monogrammable product manufactured since the last API audit
For dual & registration clients – Product currently being manufactured or services currently being
7
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
Check each requirement upon
Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be
interviewed, and processes observed) : given for any blank boxes):
Describe how the organization determines and allocates the The organization determines
required resources for the QMS, services, and activities performed: and allocates resources
needed to implement maintain
Organizational and improve the effectiveness
Capability – of the QMS
Provision of
Resources
(4.3.1)

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,
Planning validation, monitoring,
(5.2) measuring, inspection, test
activities
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, API Spec / Product:
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.

Check each requirement upon

Detail evidence observed (including records and documents
verification (explanation must be
reviewed, personnel interviewed, and processes observed) : given for any blank boxes):
Determination of requirements: Customer Requirements
Determination of Legal / other applicable
Product requirements
Requirements
Requirements not stated by
(5.1.2)
customer
Also verify:
Requirements confirmed and records
maintained where no requirements are
stated/documented by customer

Review of requirements: Reviewed prior to

commitment

Review of Requirements identified and

Product documented
Requirements Capability confirmed
(5.1.3)
Records maintained

Changes to contract requirements: Documents amended

Changes to
Requirements Changes communicated
(5.1.3)

Approval process determined,

External documented, and
Communications implemented
(4.1.5.2)
Requirements are fully
understood

Customer
Methods for obtaining / using
Satisfaction customer information
(6.2.1)

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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.

Check each requirement upon

Identify process interaction / examples of Risk Assessment & Management
verification (explanation must be
implementation and tools / techniques used: 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.

Check each requirement upon

Identify process interaction / examples of Contingency Planning implementation: verification (explanation must be
given for any blank boxes):
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. API Product Spec:

Verify that the licensee / applicant has a design package for each product under the scope of each
Design
Package Monogram License
Requirements
(Annex A, A.6 –
Monogram
Only)

Check each requirement upon

Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be
interviewed, and processes observed) : given for any blank boxes):
Design & Development Planning: Planning as per 5.4.1

Design & Design plan updated

Development Effective communication
Controls –
In-house / Design acceptance criteria
different
location within
same Design & Development Inputs: API Spec requirements
organization included (when applicable)
(5.4.1, 5.4.2, Inputs per 5.4.2
5.4.3, 5.4.4,
5.4.5, 5.4.6, Records Maintained
5.4.7) 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

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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

Supplier’s Competency and Control of Outsourced Design: Personnel Competence

Design & Records Maintained

Development
Controls – Also verify:
Outsourced - Resources, responsibilities, authorities
(5.4.1) and their interfaces
- Suppliers control, when design activities
are outsourced

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Audit Report Effective Date: 5/30/2014

Purchasing
Check each requirement upon
Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be
interviewed, and processes observed):
given for any blank boxes):
Control of Purchasing: Criticality of activities/products
determined
Type and extent of control
defined on criticality
Purchasing
Criteria, scope, frequency and
Controls methods of reassessment
(5.6.1) 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)

Check each requirement upon
Critical Suppliers Sampled: Product / Component / Activity Performed: 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

5.6.1.3 Non-Critical Suppliers – Evaluation and Reevaluation (5.6.1.4, 5.6.1.5)

Check each requirement upon
Non - Critical Suppliers
Product / Component / Activity Performed: verification (explanation must be
Sampled: 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 Check each requirement upon
interviewed, and processes observed) : verification (explanation must be

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 Doc ID: FM-198.Q1
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Audit Report Effective Date: 5/30/2014

given for any blank boxes):

Control of outsourced activities: Records Maintained

5.6.1.6 Organization’s applicable QMS

requirements satisfied
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 Records Maintained
(5.6.2)
Also verify:
Documented requirements per 5.6.2(a)(b)(c)
(d), where applicable

Verification of conformance to purchase requirements (include

records reviewed as evidence of conformance): Records Maintained
Verification
of Purchased
Product /
Activities Also verify:
(5.6.3) - Controls for verification at supplier’s
premises, where applicable

Product Quality Plan(s) (as applicable)

Check each requirement upon
Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be given
interviewed, and processes observed) : for any blank boxes):
Quality Plans sampled: Addresses each requirement of
5.7.2 (a) through (e)

Product Revisions documented /

Quality approved
Plans (if Communicated
required)
(5.7.2)

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 Doc ID: FM-198.Q1
Revision: 1.0
Audit Report Effective Date: 5/30/2014

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:

Personnel Description of Inspection Process control
Process PO / WO Product/service/
interviewed and product/ status documents (verify
(Area): number: part identified?
position/title: service/part: identified? revision):

Check each requirement upon

Detail evidence observed (including records and documents
verification (explanation must be given
reviewed, personnel interviewed, and processes observed) :
Control of for any blank boxes):
Production
Controls established and implemented for production: Procedure as per 5.7.1.1
(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

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 Doc ID: FM-198.Q1
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Audit Report Effective Date: 5/30/2014

- Product release activities

Controls established and implemented for servicing: Procedure as per 5.7.1.2

Review of requirements
Suitable equipment
Control of Identification/traceability
Servicing (if
applicable) Process control documents
(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
Process
requirements
Control
Documents Reference instructions
(5.7.1.3) Acceptance criteria
Also verify:
Inspection holds and witness points

Product realization documentation sampled: Product realization plan (5.2)

Product Records of review/verification,

Realization validation, monitoring,
Capability measurement, inspection, tests
Documents Acceptance criteria demonstrating
(5.7.1.4) capability

Validation of processes for production and services (including Demonstrates ability to achieve
Validation of outsourced): planned results
Processes Verification of supplier
for conformance to standard
Production requirements (5.6.1.6)
and Servicing
Records maintained
(5.7.1.5)

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

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 Doc ID: FM-198.Q1
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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

Check each requirement upon
Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be given
interviewed, and processes observed) : for any blank boxes):
Identification / traceability reviewed / sampled: Records maintained

Identification/
Traceability Also verify :
(5.7.3) - Delivery and post-delivery
- Maintenance / replacement of
identification / marks

Product Inspection / Test Status

Records maintained
indicating conformity /
nonconformity of product
Product
Inspection /
Test Status
(5.7.4)

Customer-supplied Property (if applicable)

Customer- Procedure per 5.7.5
supplied Records maintained
Property
(5.7.5) Also verify:
(if Requirements for reporting to customer
applicable)

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 Doc ID: FM-198.Q1
Revision: 1.0
Audit Report Effective Date: 5/30/2014

Preservation of Product
Check each requirement upon
Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be given
interviewed, and processes observed) : for any blank boxes):
Identification / traceability marks

Transportation, handling,
packaging and protection
Preservation Records maintained
of Product
(5.7.6.1)

Designated storage area / stock

rooms
Records of assessment
maintained
Storage and
Assessment
(5.7.6.2)

Preventive Maintenance
Check each requirement upon
Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be given
interviewed, and processes observed) : for any blank boxes):
Preventive maintenance for equipment used in product realization: Procedure as per 5.7.8

Type of equipment, frequency,

responsible personnel identified
Preventive Records maintained
Maintenance
(5.7.8)

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 Doc ID: FM-198.Q1
Revision: 1.0
Audit Report Effective Date: 5/30/2014

Inspection and Testing

Detail evidence observed (including records and documents reviewed, personnel
interviewed, and processes observed) :
Check each requirement upon
 For Monogram only, ensure that all inspection and testing requirements of the verification (explanation must be given
applicable product specification are addressed for any blank boxes):
 For Monogram only, please incorporate and complete the relevant Product Spec
Audit Questions
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

Inspection
and Testing
Final inspection and testing: Procedure as per 5.7.7.2
(5.7.7)
Final inspection / testing per plan
/ procedures
Evidence of conformity to
requirements maintained

Product Release
Check each requirement upon
Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be given
interviewed, and processes observed) : for any blank boxes):
Procedure as per 5.9
Release upon satisfactory
completion of planned
Product
arrangements
Release
(5.9) 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 #:

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 Doc ID: FM-198.Q1
Revision: 1.0
Audit Report Effective Date: 5/30/2014

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): Check each requirement upon

Note: For Monogram only, ensure that all inspection and testing requirements of the verification (explanation must be given
applicable product specification are addressed for any blank boxes):

Equipment: Description: Cal Date: Due Date: Uniquely identified

Calibration status identified

Traceable to Nat’l/int’l standard

Included on registry
Acceptance criteria defined and
appropriate
Records maintained

Also verify:
- Computer software confirmation

- Externally provided equipment

Control of Nonconforming Product

Check each requirement upon
Detail evidence observed (including records and documents reviewed, personnel
verification (explanation must be given for
interviewed, and processes observed) : any blank boxes):
Procedure as per 5.10.1

Method of addressing non-

conforming product per 5.10.2
Concession approved by relevant
authority and/or customer
Control of
Customer notification per 5.10.4
Nonconfor
ming Records maintained (5.10.5)
Product
Also verify:
(5.10)
- 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).

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 Doc ID: FM-198.Q1
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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 resulting
from CA / PA
Describe the organization’s process for
notification of changes. When is notification
required? To who is notification required?

Check each requirement upon

Identify process interaction / examples of Management of Change
verification (explanation must be
implementation: 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.

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 Doc ID: FM-198.Q1
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Audit Report Effective Date: 5/30/2014

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

Training Record /
Competency Defined /
Name Title Finding#:
Record Evidenced Record Evidenced

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 Doc ID: FM-198.Q1
Revision: 1.0
Audit Report Effective Date: 5/30/2014

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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