internal blank api audit checklist report draft 9th edition

Audit ReportDoc ID: FM-198

Revision: 2.1Effective Date: TBD

Table of Contents

Audit Information....................................................................................................................................... 2Verification of Scope of Registration / Monogram License(s) and Exclusions....................................3Audit Report............................................................................................................................................... 3

Management System Requirements....................................................................................................34.1.1 Quality Management System......................................................................................................34.4.1 Quality Manual............................................................................................................................ 34.1.2 Quality Policy.............................................................................................................................. 34.1.3 Quality Objectives....................................................................................................................... 44.1.5 Communication........................................................................................................................... 44.2 Management Responsibility...........................................................................................................44.3 Organizational Capability...............................................................................................................54.3.1 Provision of Resources...............................................................................................................54.3.2.2 Personnel Competence...........................................................................................................54.3.2.3 Training and Awareness..........................................................................................................64.3.3 Work Environment...................................................................................................................... 64.4 Documentation Requirements.......................................................................................................74.4.3 Control of Documents................................................................................................................. 74.5 Control of Records......................................................................................................................... 7

QMS Monitoring, Measurement, Analysis & Improvement................................................................86.2.1 Customer Satisfaction................................................................................................................. 86.2.2 Internal Audits............................................................................................................................. 86.2.3 Process Evaluation..................................................................................................................... 96.3 Analysis of Data............................................................................................................................. 96.4.2 Corrective Action........................................................................................................................ 96.4.3 Preventive Action...................................................................................................................... 106.5 Management Review................................................................................................................... 10

Risk Assessment & Management.......................................................................................................11Contingency Planning.........................................................................................................................12Management of Change...................................................................................................................... 12

Product Realization................................................................................................................................. 14Audit Conditions...................................................................................................................................... 14

Product Realization – Contract Review.............................................................................................15Product Realization - Design & Development...................................................................................17Product Realization - Purchasing.......................................................................................................19Product Realization – Production and Servicing..............................................................................22Use of API Monogram, APIQR and ANAB Marks..............................................................................27

Audit Time Summary............................................................................................................................... 28Audit Summary........................................................................................................................................ 28Conclusion / Recommendation..............................................................................................................29Supplemental Audit Information............................................................................................................30Findings Summary.................................................................................................................................. 31Opening / Closing Meeting Attendance Sheet......................................................................................32Audit Package Checklist......................................................................................................................... 33

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Top of the Document

Audit Information

Facility ID: Audit ID: Facility Name:

Lead Auditor:

Audit Team Members:

Audit Start Date: Audit End Date:

Shifts: Start Time End Time No. ofEmployees Audited? (Y/N)

Shift 1

Shift 2

Shift 3Explanation(required for

shifts not audited):

Additional Comments:

Audit Criteria:

ISO 9001 API Spec Q1 API Spec Q2ISO/TS 29001 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 YesIf yes, include changes on facility info sheetActual Number of

Employees:

Required Audit Days: Actual Audit Days:

Justification required if different from required audit days

Justification (Notify API of changes):

Additional Comments:

Number of Findings: Major (Systemic):

Minor (Isolated): Concerns:

Comments:

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Top of the Document

Verification of Scope of Registration / Monogram License(s) and Exclusions

Verify each of the following: Select One: Finding #:

Scope of registration is accurate for the activities and processes performed by the facility.

Yes

No – Note all changes on the applicable QAR, as well as an explanation for the changes

Monogram Only - Product scope of Monogram License is accurate for the activities and processes performed by the facility and facility has the manufacturing capability for each product within the scope of the license(s).

Yes

No – Note all changes on the applicable QAR, as well as an explanation for the changes

N/A – No Monogram License(s)

Exclusions taken are allowable, applicable and justified. Document any discrepancies.

Exclusions are Accurate and Appropriate

No Exclusions

Exclusions should be updated as follows:

Additional comments:

Audit Report

Management System RequirementsIn the space provided below, detail the objective evidence (documentation reviewed, records reviewed and personnel interviewed) to

ensure conformance with QMS requirements. Detail any discrepancies / nonconformance identified.

Requirement: Objective Evidence/Comments: Finding #:

4.1.1 Quality Management System

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.

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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


4.1.5 Communication

4.1.5.1 Internal CommunicationVerify that the organization has established appropriate communication processes and the effectiveness of the MS is communicated.

Verify that processes have been established to ensure that the importance of meeting requirements and analysis of data is communicated at relevant functions.

4.1.5.2 External CommunicationVerify that the organization has established appropriate communication with external customers to ensure that requirements are understood.

Verify that communications processes meet applicable requirements of the standard.


4.2 Management Responsibility

4.2.1 Resources

Describe how top management ensures availability of resources essential to the QMS.

4.2.2 Responsibility and Authority

Describe how responsibilities, authorities, and accountabilities are defined, documented and communicated throughout the organization.

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4.2.3 Management Representative

Identify the name of the appointed Management Representative.

Verify Competence, Training & Awareness for appointment.

Verify applicable responsibility and authority has been granted.

Describe how the Management Representative reports to management on the performance of the MS.


4.3 Organizational Capability

4.3.1 Provision of Resources

Describe how the organization determines and allocates resources needed to implement, maintain and improve the effectiveness of the requirements of the MS.


4.3.2.2 Personnel Competence Procedure:

Verify that the procedure meets all requirements of the applicable standard and is controlled, implemented, and maintained.

How does the organization determine the necessary competence for personnel performing work affecting product quality?

What actions does the organization take to address position competency requirements?

Verify risk assessment associated with product quality includes the availability of competent personnel. Ensure risks are identified and controlled (5.3c).

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4.3.2.3 Training and Awareness Procedure:


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 evaluated and maintained (i.e., competence evaluation) to ensure competence requirements are met.


4.3.3 Work Environment

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).

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4.4 Documentation Requirements

4.4.2 Procedures

Verify that procedure required by the standard are established, documented, implemented, and maintained for continual suitability.

4.4.3 Control of Documents Procedure:


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 Procedure:


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.

4.5 Control of Records Procedure:


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 & Improvement

Requirements: Objective Evidence / Comments: Finding #:

6.2.1 Customer Satisfaction Procedure:


What methods have the organization implemented for obtaining and using information relating to customer perception as to whether requirements have been met?

How has the organization effectively measured customer satisfaction and analyzed the results?

6.2.2 Internal Audits Procedure:


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 MS, whether performed at one time or over the period of 12 months.

Did internal audit planning take into account results of previous audits and criticality of the process being audited?

Verify that the internal audit performed: conforms to planned arrangements including the

requirements of the applicable standard / specification;

has been effectively implemented and maintained, including records;

was performed by independent / objective, competent personnel;

include outsourced activities that impact the quality of the product and that are performed at the facility;and

includes all processes required by the MS required to meet the applicable standard / specification.

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Describe how the organization addresses nonconformances identified during the internal audit (e.g., response times, responsibilities, reporting, and records).

6.2.3 Process Evaluation

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.


6.3 Analysis of Data Procedure:


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 MethodReported

How Frequency Objective / KPI

Customer Satisfaction

Supplier Information

Product Conformity

Internal Audit


6.4.2 Corrective Action Procedure:


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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 verified for effectiveness.

How are corrective actions initiated? How are response times for addressing corrective actions tracked?

6.4.3 Preventive Action Procedure:

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.


6.5 Management Review Procedure:


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.

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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

Risk Assessment & Management


5.3 Risk Management & Assessment Procedure:

Verify the procedure meets all requirements of the standard and is controlled, implemented, and maintained.

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.

Identifyprocess interaction / examples of Risk Assessment & Management implementation and tools / techniques used:

Check each requirement upon verification(explanation must be given for any blank boxes):

Risks identified

Risks assessed

Risks mitigated

Records maintained

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Contingency Planning


5.5 Contingency Planning Procedure:

Verify the procedure meets all requirements of the standard and is controlled, implemented, and maintained.

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.

Identifyprocess interaction / examples of Contingency Planning implementation:Check each requirement upon verification(explanation must be given for any blank boxes):

Based on assessed risks

Output documented / updated as required

Output communicated

Records maintained

Management of Change


5.11 MOC Process

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.

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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; andto 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?

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

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Product Realization

Audit ConditionsThe 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. Determine the availability of the products for review and review processes in conjunction with these products. As a reminder, product and service are to be considered the same. Priority should be established at the start of the audit to verify manufacturing according to the following conditions:

Category Category Definition

1 Monogram product currently being manufactured and available for review

2 Monogrammable (product meeting all requirements but not marked) product currently being manufactured and available for review

3 Non-monogrammable product currently being manufactured and available for review4 Monogram product manufactured since the last API audit but not available for review (records review)

5 Monogrammable product manufactured since the last API audit but not available for review (records review)

6 Non-monogrammable product manufactured since the last API audit

7 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 see API Certification Programs advisory 8 regarding implementation of QMS requirements by a Licensee at http://www.api.org/certifications/monogram/documents/advisories.cfm

NOTE 2: Please identify any products / services that are being added to the scope of Licensing and / or Registration, including products / services that are “new” and have been added since the last audit. These products / services must be considered when sampling objective evidence during the audit. For example, design packages, process controls and capabilities, etc.

Complete the table below based on the above classifications:

Category Product/Service Identification Specification (as applicable)

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Top of the Document

Product Realization –Contract ReviewRequired Procedure:Verify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained.

Finding #:

5.1.1 Contract Review Procedure:

Contract Review (5.1.1)

List all Contracts reviewed / sampled:

Determination of Product Requirements (5.1.2)

Detail evidence observed(including records and documents reviewed, personnel interviewed, and processes observed):


Determination of requirements: Customer Requirements

Legal / other applicable requirements

Requirements not stated by customer

Also verify: Requirements confirmed and records maintained where no requirements are stated/documented by customer

Review of Product Requirements(5.1.3)

Review of requirements: Reviewed prior to commitment

Requirements identified and documented

Capability confirmed

Records maintained

Changes to Requirements(5.1.3)

Changes to contract requirements: Documents amended

Changes communicated

Auditor’s Assessment of Process(es):

Finding/Concern Identified? No Yes, If Yes – Finding No(s):

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Product Realization – Planning

Planning(5.2)



Planning of product realization: Consistent with QMS process

Required resources / work environment (4.3)

Product / customer requirement (5.1)

Legal / other applicable requirements

Contingencies based on risk assessment (5.3, 5.5)

Design and development requirements (5.4)

Required verification, validation, monitoring, measuring, inspection, test activities

MOC (5.11)

Records maintained

Output of product realization planning: Output documented

Plans updated as changes occur

Plans maintained suitably


Finding/Concern Identified? No Yes, If Yes – Finding No(s):

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Product Realization - Design & DevelopmentRequired Procedure:Verify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained.

Finding #:

5.4 Design & Development Planning & Control Procedure:

Design & Development Activities

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)Note: 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.

Design Package Requirements (Monogram Only)(Annex A.6)

Verify that the licensee/applicant has a design package for each product under the scope of each Monogram License if design is required.

Design & Development Controls –In-house / different location within same organization(5.4.1, 5.4.2, 5.4.3, 5.4.4, 5.4.5, 5.4.6, 5.4.7)



Design & Development Planning: Planning as per 5.4.1

Design plan updated

Effective communication

Design acceptance criteria

Design & Development Inputs: API Spec requirements included (when applicable)

Inputs per 5.4.2

Records Maintained

Also verify: - Customer requirements (5.1) - Results from risk assessment (5.3)- Requirements from external sources (API)

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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

Design & Development Controls – Outsourced(5.4.1)

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

Records Maintained

Also verify: -Resources, responsibilities, authorities

and their interfaces- Suppliers control, when design activities

are outsourced

Training & Competence(Design & Development)(4.3.2.2, 4.3.2.3)

Qualification/competency of personnel: Competent/Qualified

Training Evaluation

Records Maintained


Finding/Concern Identified? No Yes - If Yes – Finding No(s):

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Product Realization -PurchasingRequired Procedure(s): Verify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained. Finding #:

5.6.1.1 Purchasing Procedure:

5.6.3 Verification of Purchased Products and Activities Procedure:

5.7.3 Identification and Traceability Procedure:

5.7.4 Product Inspection/Test Status Procedure:

5.7.5 Customer-supplied Property Procedure:

5.7.6.1Preservation of Product Procedure:

Purchasing Controls(5.6.1)



Control of Purchasing: Criticality of activities/products determined

Type and extent of control defined on criticality

Criteria, scope, frequency and methods of reassessment definedList of approved suppliers and scope of approval

Critical Suppliers – Evaluation and Reevaluation(5.6.1.2, 5.6.1.4)

Suppliers sampled and product/component/activity performed: Initial capability assessment per 5.6.1.2 (a,b)

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).

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

Suppliers sampled and 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).

Outsourced Activities

List all outsourced activities and processes (if applicable): Organization’s applicable QMS requirements satisfied

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(5.6.1.6)

Records Maintained

Also verify:Organization maintains responsibility for product conformance to specified requirements including API Spec

Control of outsourced activities:

Purchasing Information (5.6.2)

Purchasing Information (include contracts/POs sampled -minimum of 3): Acceptance criteria documented

Records Maintained

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

Verification of Purchased Product / Activities (5.6.3)

Verification of conformance to purchase requirements (include records reviewed as evidence of conformance):

Records Maintained

Also verify: - Controls for verification at supplier’s

premises, where applicable

Identification and Traceability (5.7.3)

Verification of identification / traceability (as applicable): Records Maintained

Delivery and post-delivery activities

Maintenance and replacement of identification / marks

Also verify: Identification and traceability of customer-supplied products

Product Inspection / Test Status(5.7.4)

Identification of inspection and/or test status (as applicable): Indicates conformity / non-conformity or product

Records Maintained

Also verify: Release of product that meets requirementsor authorized under concession

Control of customer-supplied property (if applicable): Procedure per 5.7.5

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supplied Property(5.7.5)

Records maintained

Also verify:Requirements for reporting to customer

Preservation of Product; Storage and Assessment (5.7.6, 5.7.6.2)

Preservation of products and constituent parts (include evidence of verification of stock assessment):

Procedure per 5.7.6.1

Requirements for storage and assessment identified

Designated storage areas

Records maintained

Also verify: - Identification/traceability marks,

transportation, handling, packaging and protection

- Interval appropriate to the product/part being assessed

Inspection and testing(5.7.7)

Inspection and testing of purchased product / services: Procedure per 5.7.7.1

Evidence of conformity with acceptance criteria maintained

Training & Awareness; Personnel Competence (in-house and outsourced)(4.3.2.2, 4.3.2.3)

Qualification/competency of personnel: Training frequency and contents identified

Competent/qualified

Training evaluation

Records maintained

Also verify: - Customer-specified/provided training-Awareness of personnel with respect to their activities/contribution to QMS


Finding/Concern Identified? No Yes - If Yes – Finding No(s):

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Product Realization – Production and Servicing

Other processes included:

Production & Service Provision Personnel Competence

Training & Awareness Control of Testing, Measuring & Monitoring Equipment

Product Release MOC

Control of Nonconforming Product Risk Assessment & Management

Manufacturing Capability Required Procedure:Verify that procedure(s) meet all requirements of the applicable standard and is controlled, implemented, and maintained.

Finding #:

5.7.1.1 Production Procedure:

5.7.1.2 Servicing (if applicable) Procedure:

5.7.8 Preventive Maintenance Procedure:

5.8 Control of Testing, Monitoring and Measurement Equipment Procedure:

5.9 Product Release Procedure:

Production and/or Servicing Provide a detailed overview of the production / servicing activities and capabilities observed at the facility. Include all monogrammable and non-monogrammable products.

Description of Production and/or Servicing processes (describe what manufacturing processes actually take place at the facility and interactions):

Description of Production / Servicing capabilities [What capabilities does the facility have (i.e., are they capable of manufacturing, what are they capable of manufacturing)?]:

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Production / Servicing Activities

List production / servicing processes reviewed / sampled:

Control of Production (5.7.1.1)



Controls established and implemented for production: Procedure as per 5.7.1.1

Design requirements/changes

Suitable equipment

Process control documents

Also verify: - Implementation of Quality Plan, if

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

Control of Servicing (if applicable)(5.7.1.2)

Controls established and implemented for servicing: Procedure as per 5.7.1.2

Review of requirements

Suitable equipment

Identification/traceability

Process control documents

Also verify: - Work instructions, when applicable- Monitoring & measuring activities - Requirements for release of serviced

product

Process Control Documents(5.7.1.3)

Documentation of process controls: Includes requirements for verifying conformance with quality plans, product specs, customer requirements

Reference instructions

Acceptance criteria

Also verify: Inspection holds and witness points

Product Realization Capability Documents(5.7.1.4)

Product realization documentation sampled: Product realization plan (5.2)

Records of review/verification, validation, monitoring, measurement, inspection, tests

Acceptance criteria demonstrating capability to manufacture products/family of products

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Validation of Processes for Production and Servicing(5.7.1.5)

Validation of processes for production and services (including outsourced):

Demonstrates ability to achieve planned results

Verification of supplier conformance to standard requirements (5.6.1.6)

Records maintained

Product Quality Plans (if required)(5.7.2)

Product quality plan required by the contract: Addresses each requirement of 5.7.2 (a) through (e)

Revisions documented / approved

Communicated

Identification and Traceability; Product Inspection / Test Status; Preservation of Product(5.7.3, 5.7.4, 5.7.5, 5.7.6)

Identification / traceability throughout product realization process:

Records maintained

Also verify :- Delivery and post-delivery- Maintenance / replacement of

identification / marks

Identification of inspection / test status throughout product realization process:

Records maintained indicating conformity / nonconformity of product

Customer-supplied property throughout product realization (if applicable):

Procedure per 5.7.5

Records maintained

Also verify:Requirements for reporting to customer

Preservation of product throughout product realization and delivery:

Identification / traceability marks

Transportation, handling, packaging and protection

Records maintained

Storage and assessment throughout product realization and delivery:

Designated storage area / stock rooms

Records of assessment maintained

Inspection In-process inspection and testing: Procedure as per 5.7.7.1

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and Testing (5.7.7)

Inspection / testing at planned stages per plan / procedure

Evidence of conformity with acceptance criteria maintained

Final inspection and testing: Procedure as per 5.7.7.2

Final inspection / testing per plan / procedures

Evidence of conformity to requirements maintained

Preventive Maintenance (5.7.8)

Preventive maintenance for equipment used in product realization:

Procedure as per 5.7.8

Type of equipment, frequency, responsible personnel identified

Records maintained

Control of Testing, Monitoring and Measuring Equipment(5.8)

Control and maintenance of testing, monitoring and measuring equipment:

Procedure as per 5.8

Identification, status, traceability, frequency, calibration/verification methods, acceptance criteria

Also verify: Control of out-of –tolerance equipment and assessment of previous measurements

Testing, monitoring and measurement equipment sampled: Uniquely identified

Calibration status identified

Traceable to nat’l/int’l standard

Included on registry

Records maintained

Also verify: -Computer software confirmation- Externally provided equipment

Product Release of product: Procedure as per 5.9

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Release(5.9)

Release upon satisfactory completion of planned arrangements

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

Control of Nonconforming Product (5.10)

Control of nonconforming product: Procedure as per 5.10.1

Method of addressing non-conforming product identified per 5.10.2

Concession approved by relevant authority and/or customer

Customer notification per 5.10.4

Records maintained (5.10.5)

Also verify: - Proper identification to prevent

unintended use- Addressing the nonconformity- Identification, documentation, analysis

and actions taken for nonconforming product identified after delivery

- Risk assessment associated with product quality includes supplier performance. Ensure risks are identified and controlled (5.3b).

Training / Competence(production and servicing personnel)(4.3.2.2, 4.3.2.3)

Qualification/Competency of personnel: Training frequency and contents identified

Competent/qualified

Training evaluation

Records maintained

Also verify: - Customer-specified / provided - Outsourced personnel

qualification/competence


Findings / Concerns Identified? No Yes - If yes, Finding No(s):

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Use of API Monogram, APIQR and ANAB Marks

A.5 Control of the Application of the API Monogram Procedure:


Verify the procedure documents all marking/monogramming requirements includes all requirements of Annex A.

Describe the licensee’s API Monogram marking removal procedure for non-conforming product. Identify evidence of implementation, if applicable.

AMA - if the facility has an AMA, identify the marking facility and detail controls established.

List all API MonogramMarks sampled(on products, letterhead, business cards or any other medium):

Product conforms to API-spec requirements

Applied by licensee only

Includes mark and license number

Applied at licensed facility location

Verify conformance of the following requirements for use of the Monogram and ANAB/APIQR mark. Any Noselected 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.

TheAPIQR / 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:5. in black, its original colors or the predominant color of the letterhead or printing, 6. on a clearly contrasting background, and 7. 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.

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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 7If 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 within the scope of the 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 nonconformance(s) identified and acceptance of appropriate corrective action(s) by the API Registration & Licensing Committee. This decision may include a re-audit to verify the required corrective actions.

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 licensure 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.Comments / Notes:

Final Auditor / Audit Team Remarks:

Organization’s Representative Comments:

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: 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:

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; that a copy of this document (FM-198) was left; 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 by in the audit AARs and final audit report.

Organization Representative: Date:

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Supplemental Audit InformationEnter additional information relevant to the audit, if necessary;please include process(es) audited/verified:

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Findings / Concerns Identified? No Yes - If yes, Finding Nos:

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Findings Summary

Finding Number

N/C or Concern

Product Impact Summary Auditor Initials

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

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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Opening / Closing Meeting Attendance SheetWhen 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 Package Checklist

Facility Information Sheet** Product Questions* Stage 1 Audit Report*

QAR(s)** Q1, 9th Edition Gap Analysis Findings (AARs)*

* If required**Please update as necessary

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internal blank api audit checklist report draft 9th edition

Leadership & Management