API's 9th internal audit form.docx

Audit Report - Q1

Audit ReportDoc ID: FM-198.Q1Revision: 1.0Effective Date: 5/30/2014

ContentsAudit Information2Audit Time Summary3Audit Summary3Conclusion / Recommendation4Opening / Closing Meeting Attendance Sheet5Findings Summary6Audit Report7Verification of Scope of Registration / Monogram License(s) and Exclusions7Use of API Monogram, APIQR and ANAB Marks8Quality Management System Requirements9Communication Processes10Management Responsibility10Documentation Requirements11QMS Monitoring, Measurement, Analysis, and Improvement13Management Review13Analysis of Data14Process Evaluation14Internal Audits14Improvement Processes Corrective / Preventive Action15Product Realization16Audit Conditions16Planning17Contract Review / Customer Related Processes18Risk Assessment & Management19Contingency Planning19Design & Development20Purchasing22Product Quality Plan(s) (as applicable)23Production and Servicing Processes24Product Release28Control of Testing, Monitoring and Measuring Equipment29Control of Nonconforming Product29Management of Change30Human Resources / Competence / Training Processes30Supplemental Audit Information32Audit Package Checklist32

Audit Information

Facility ID: Audit ID:

Facility Name:

Lead Auditor:

Audit Team Members:

Audit Start Date:Audit End Date:

Audit Type (Initial, Surveillance, Re-audit, etc.):

Audit Criteria:API Spec Q1API Spec Q2OHSAS 18001

ISO 9001ISO 14001

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

Other criteria:

QMS and Applicable Standards/Specifications (verify current versions):

Audit Scope/Objective:

Facility Info Changes NoYes If yes, include changes on facility info sheet

Actual Number of Employees:

Required Audit Days (Refer to timetable guidelines): Actual Audit Days: Justification required if different from required audit days

Justification (Notify API of changes):

Additional Comments:

Shifts:Start TimeEnd TimeNo. of EmployeesAudited? (Y/N)

Shift 1

Shift 2

Shift 3

Explanation (required for shifts not audited):

Additional Comments:

Number of Findings: Major (Systemic):Minor (Isolated):Concerns:

Comments:

Audit Time Summary

DateStart TimeEnd TimeFacility Rep Initials

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

If audit duration is longer than 7 days, please add additional daily start/stop time. Time spent auditing offsite or at other locations, such as subcontractors, must be identified and noted in the audit report.

Audit Summary

Strengths:

Opportunities for Improvement (OFIs):

Provide a summary of the closure and verification of corrective actions for previous findings, if any:

Provide an overall assessment of the capability of the facility to manufacture product(s) (Monogram):

Provide an overall assessment of the effectiveness of the management system and the facilitys ability to perform activities / provide products within the scope of registration:

Conclusion / Recommendation

Registration and / or Licensing are granted / continued / reinstated based on satisfactory implementation of a Management System and / or demonstrated capability to meet applicable specification requirements with no nonconformities identified.

Registration and / or Licensing be granted / continued / reinstated subject to the review of the nonconformance(s) identified and acceptance of appropriate corrective action(s) by the API Registration & Licensing Committee.

Registration and / or Licensing subject to the review of the audit results and nonconformance(s) identified, acceptance of appropriate corrective action(s) and additional actions as defined by the API Registration & Licensing Committee. This decision may include a re-audit to verify the required corrective actions, withdrawal, suspension and or cancelation.

Note: Audits may result in suspension or cancellation of the organizations license(s) and/or registration(s) or withdrawal of application for licensing/registration. API makes the final determination of certification status and shall be the sole judge of whether licensing or registration will be granted/maintained. You will be notified by API if your license/registration is adversely affected by the results of this audit.

Final Auditor / Audit Team Remarks:

Organizations Representative Comments:

By signing below, I (we) attest that the information above is accurate and has been collected by the audit team during the performance of the audit that was assigned to me (us) by API and that audit recommendations and conclusions were communicated to the organization.

Audit Team Leader: Date:

Audit Team Member: Date:

Audit Team Member: Date:

By signing this document, it is not an admission of the acceptance of any nonconformities/concerns identified by the audit team. The signature only confirms that the audit was performed and the audit recommendations and audit conclusions were communicated by the auditor. API reserves the right to have final determination of the level of nonconformity identified in the audit AARs and final audit report.

Organization Representative (optional): Date:

Enter the next audit date for Dual/Registration Audits below (Does not apply to Monogram only audits): First surveillance audit after stage 2 initial audit MUST be scheduled 9 months after the last day of the stage 2 audit Second / subsequent surveillance audits around audit anniversary date of initial / first surveillance audit Recertification audits at least 6 months prior to the expiration dates

Next Audit Type: Next Audit Date:

Top of the Document

Opening / Closing Meeting Attendance Sheet

When performing the opening and closing meeting, please refer to the Opening and Closing meeting guidelines

Facility ID: Audit ID:

Audit Team Leader:

Audit Team Members:

Audit Observer(s):

Opening Meeting (Day & Time):

Closing Meeting (Day & Time):

Participants (Name & Title) - Initial/check the meetings attendedOpeningClosing

The information contained in this report is confidential and subject to the confidentiality agreement between the Audit Team/Auditor(s) and API. Details of the assessment results are found in the succeeding pages of this report.

Findings Summary

Finding NumberN/C or ConcernProduct Impact

API Spec/ ClauseSummaryAuditor Initials

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

YesNo

Audit Report

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

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

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

No If No, note all changes on the applicable QAR, as well as an explanation for the changes

N/A No Certificates of Registration

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

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

N/A No Monogram License(s)

Exclusions taken are allowable, applicable and justified. Document any discrepancies.Note: Please see Advisory 6 for allowable Monogram Program design exclusions.Exclusions are Accurate and Appropriate

No Exclusions

Exclusions should be updated as follows:

Additional comments: No If No, note all changes on the applicable QAR, as well as an explanation for the changes

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

Use of API Monogram, APIQR and ANAB Marks

A.5 Control of the Application of the API Monogram

Requirements:Objective Evidence / Comments:Finding #:

Verify the marking/monogramming procedure addresses all requirements of Annex A.5.

Describe the licensees procedure for removal of the Monogram from non-conforming product. Identify evidence of implementation, if applicable.

AMA (Alternative Marking Agreement) if the facility has an AMA, identify the marking facility and the controls established.

API Monogram Marks sampled (on products, letterhead, business cards or any other medium): Note: The Monogram and License Number must be used together at all times. They cannot be used on test certificates, certificates of conformity, shipping documents, etc.API Spec:Verify each of the following:

Product conforms to API-spec requirements

Applied by licensee only

Includes mark and license number

Applied to product at licensed facility location

Verify conformance of the following requirements for use of the ANAB/APIQR mark. Any No selected is considered a nonconformance. YesNoN/A

APIQR Marks are only on correspondence, advertising, and promotional materials that are related to the goods and services referenced in the scope of the Organizations registration.

The APIQR / ANAB Mark has not been used on a product or in such a way as to suggest that APIQR / ANAB have certified or approved any product, process or service of the registered organization.

The APIQR and ANAB Marks are used in conjunction with the organizations name, location and registration certificate numbers.

The ANAB Mark is used in conjunction with the APIQR Mark.

The APIQR and ANAB Marks are reproduced:1. in black, its original colors or the predominant color of the letterhead or printing, 2. on a clearly contrasting background, and 3. in a size which makes the marks features clearly distinguishable, the length of a side being in no case less than 12mm (APIQR Mark) and 10mm (ANAB Mark).

Upon written notification, the organization immediately ceased and desisted in the use of the APIQR/ANAB Marks and/or API Monogram 1) upon suspension or cancellation or 2) use in any manner, which API/APIQR interprets as misleading.

Applicant organization APIQR, ANAB Marks and/or API Monogram have not been identified in promotional materials or other company documentation.

Additional comments:

Quality Management System Requirements

In the space provided below, detail the objective evidence (documentation reviewed, records reviewed and personnel interviewed) to ensure conformance with QMS requirements. Detail any discrepancies / nonconformances identified.

Requirement:Objective Evidence/Comments: Finding #:

Verify that the organization has established, documented, implemented and maintained a QMS for all servicing and products provided for use in the petroleum and natural gas industry.

4.4.1 Quality Manual

Verify that the QM addresses the following requirements: Scope of the QMS, including exclusions Interaction & sequence of processes Processes that require validation Reference to documented procedures that control the QMS

4.1.2 Quality Policy

Verify that the Quality Policy has been defined, documented and approved as required and meets all requirements identified in the applicable standard.

4.1.3 Quality Objectives

Verify that Quality Objectives are approved, documented, and established at relevant functions and levels and are measurable and consistent with the Quality Policy.

Verify KPIs are identified for use in Data Analysis.

4.1.4 Planning

Verify that management has ensured that: criteria and methods needed for the operation and control of the QMS are determined, managed and are effective planning of the QMS is carried out to meet spec requirements

Communication Processes


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


4.2.1 Resources

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

4.2.3 Management Representative

Identify the name of the organizations Management Representative and roles / responsibilities.

Verify the following: Competence, training & awareness for appointment; and Applicable responsibility and authority has been granted.

Describe how the MR reports to management on the performance of the QMS.

Documentation Requirements

4.4.2 Procedures

Verify that procedures required by the standard are established, documented, implemented, and maintained for continual suitability. (Please complete the Identification of QMS Procedures table.)

ClauseRequirementProcedure ID: Revision:Finding#:

4.3.2.2Competency

4.3.2.3Training

4.4.3Control of Documents

4.5Control of Records

5.1.1Review of Requirements

5.3Risk Assessment & Management

5.4.1Design & Development Planning

5.5Contingency Planning

5.6Purchasing

5.6.3Verification of Purchased Products or Activities

5.7.1.1Control of Production

5.7.1.2Control of Servicing

5.7.3Identification & Traceability

5.7.4Product Inspection/Test

5.7.5Customer-supplied Property

5.7.6Preservation of Product

5.7.7Inspection & Testing

5.7.8Preventive Maintenance

5.8Control of Testing, Measuring, & Monitoring Equipment

5.9Product Release

5.10Control of Nonconforming Product

6.2.1Customer Satisfaction

6.2.2Internal Audit

6.3Analysis of Data

6.4.2Corrective Action

6.4.3Preventive Action

Annex AMonogram Marking Note: Mark N/A if registration only

4.4.3 Control of Documents


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


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

How does the facility identify, store, protect, retain, retrieve and dispose of records?

Has the facility identified controls and responsibilities needed to identify, collect, store, protect, retain, retrieve and dispose of records?

Has the facility maintained records based on the required retention times as specified in the applicable standard, product spec, and / or the customer / QMS requirements?

QMS Monitoring, Measurement, Analysis, and Improvement


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


Identify date(s) of management reviews within the last 12-month period. (Verify that management reviews are conducted at least every 12 months.)

Verify that the management review has been documented with sufficient evidence to demonstrate conformity with applicable requirements. If no, note deficiencies.

6.5.2 Review Input - Verify that the management review includes all inputs required by the applicable standard, including: Result of audits Customer Feedback Results of Risk Assessment Status of CA / PA Supplier Performance Analysis Process Performance and Product Conformity Changes that could affect the MS Recommendations for Improvement

6.5.3 Review Output - Verify that the management review output includes a summary assessment of the effectiveness of the MS detailing any: Required changes to the processes Decisions and actions Required resources Improvement for products

Analysis of Data

Requirements:Objective Evidence / Comments:

What data have been determined, collected and analyzed to demonstrate the suitability and effectiveness of the QMS? [Such data analysis may be related to quality objectives and result in modifications to these objectives, number of nonconforming product, etc.]

Data TypesAnalysis MethodReported

HowFrequencyObjective / KPI

Customer Satisfaction

Supplier Performance

Product Conformity

Nonconformities / product failures after delivery / use

Process trends and characteristics

Opportunities for Preventive Action

Quality Objectives

Internal Audit

Process Evaluation


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


Identify the date the last internal audit was completed. Verify that the audit was performed within 12 months from the previous internal audit (if applicable). Note: API interprets Last Internal Audit to mean the last complete audit of the ENTIRE QMS, whether performed at one time or over the period of 12 months.

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

Verify that the internal audit performed: conforms to planned arrangements including the requirements of the applicable standard / specification; has been effectively implemented and maintained, including records; was performed by independent / objective, competent personnel; include outsourced activities that impact the quality of the product and that are performed at the facility; and includes all processes required by the MS required to meet the applicable standard / specification

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

Improvement Processes Corrective / Preventive Action

6.4.2 Corrective Action


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


What actions are taken by the organization to minimize the likelihood of potential nonconformities? Actions should include: determining potential nonconformities and their cause evaluating action to prevent occurrence determining/implementing action needed recording of results reviewing preventive action taken.

Product Realization

Audit Conditions

1. The audit must determine the degree to which products are being manufactured under the scope of the applicable API Monogram License(s) and / or Registered QMS. 2. Determine the availability of the products for review and audit processes in conjunction with these products. 3. It is intended that this be completed prior to the audit as part of the planning process. In cases where pre-audit information is not available this MUST be done during the opening meeting/facility tour.4. Please include as many products as possible that are included as part of the scope of Licensing / Registration.5. Priority should be established at the start of the audit to verify manufacturing according to the conditions outlined below.

CategoryCategory Definition

1Monogram product currently being manufactured and available for review

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

3Non-monogrammable product currently being manufactured and available for review

4Monogram product manufactured since the last API audit but not available for review (records review)

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

6Non-monogrammable product manufactured since the last API audit

7For dual & registration clients Product currently being manufactured or services currently being provided that fall under the scope of the registered quality management system.

NOTE 1: Please refer to API Spec Q1, Annex A, A.4 regarding the requirement for a Licensee to develop, maintain and operate at all times a QMS conforming to API Spec Q1NOTE 2: Please identify any products that are being added to the scope of Licensing and / or Registration, including products that are new and have been added since the last audit. These products must be considered when sampling objective evidence during the audit.

Complete the table below based on the above classifications:

CategoryProduct/Service IdentificationSpecification (as applicable)

Planning

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

Organizational Capability Provision of Resources (4.3.1)Describe how the organization determines and allocates the required resources for the QMS, services, and activities performed:

The organization determines and allocates resources needed to implement maintain and improve the effectiveness of the QMS

Planning (5.2)

Planning of product realization:

Consistent with QMS process

Required resources / work environment (4.3)

Product / customer requirement (5.1)

Legal / other applicable requirements

Contingencies based on risk assessment (5.3, 5.5)

Design and development requirements (5.4)

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

MOC (5.11)

Records maintained

Output of product realization planning:

Output documented

Plans updated as changes occur

Plans maintained suitably

Contract Review / Customer Related Processes

List all Contracts reviewed / sampled (minimum of 3 include contract identification, customer name, date of contract and any other pertinent details below): NOTE: Sampling must consider range of products with Licensing / QMS scope and sample must be increased based on number of products within scope, volume of work, etc.API Spec / Product:

Determination of Product Requirements (5.1.2)

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

Determination of requirements: Customer Requirements

Legal / other applicable requirements

Requirements not stated by customer

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

Review of Product Requirements(5.1.3)Review of requirements: Reviewed prior to commitment

Requirements identified and documented

Capability confirmed

Records maintained

Changes to Requirements(5.1.3)

Changes to contract requirements:

Documents amended

Changes communicated

External Communications(4.1.5.2)

Approval process determined, documented, and implemented

Requirements are fully understood

Customer Satisfaction(6.2.1)

Methods for obtaining / using customer information

Risk Assessment & Management


Verify the RM process has been established to identify and control risks associated with: impact on delivery, including facility/equipment availability, maintenance and supplier performance and material availability/supply; quality of product, including delivery of nonconforming product & availability of competent personnel.

Describe the tools, techniques and their application for risk identification, assessment and mitigation utilized by the organization.

Identify process interaction / examples of Risk Assessment & Management implementation and tools / techniques used: Check each requirement upon verification (explanation must be given for any blank boxes):

Risks Identified

Contingency Planning


Verify that contingency planning is based on assessed risks (5.3).

Verify that the output of contingency planning is documented, updated and communicated as required.

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

Based on assessed risks

Output documented / updated as required

Output communicated

Records maintained

Design & Development

Select all that apply:

Performed in-house

Performed at a different location within the same organization

Outsourced

Excluded; Justification confirmed (per API Advisory 6)

List design packages sampled / verified: (Select a representative sampling (minimum of three) of the applicable products (per API Specifications or Registration Scope) Any license in application status requires verification of all product designs within that specification. Any product additions to existing licenses must have evidence of existing designs. Please incorporate and complete the relevant Product Spec Audit Questions It may not be sufficient for the Licensee/applicant to have only 1 package that covers a product. Separate packages may be required / sampled based on different sizes, pressure ratings, etc.API Product Spec:

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


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

Planning as per 5.4.1

Design plan updated

Effective communication

Design acceptance criteria

Design & Development Inputs:

API Spec requirements included (when applicable)

Inputs per 5.4.2

Records Maintained

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

Design & Development Outputs:

Output as per 5.4.3

Records Maintained

Also verify: - DAC identified / referenced- Critical products/components identified / referenced

Design & Development Review:

Review as per 5.4.4

Records Maintained

Design & Development Final Review & Verification:

Verification and Final Review as per 5.4.5

Conducted / documented per planned arrangement (5.4.1)

Records Maintained

Design & Development Validation & Approval:

Validation and Approval as per 5.4.6

Records Maintained

Design & Development Changes:

Changes as per 5.4.7

Records Maintained

Design & Development Controls Outsourced (5.4.1)Suppliers Competency and Control of Outsourced Design:

Personnel Competence

Records Maintained

Also verify: - Resources, responsibilities, authorities and their interfaces- Suppliers control, when design activities are outsourced

Purchasing

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

Purchasing Controls(5.6.1)Control of Purchasing:

Criticality of activities/products determined

Type and extent of control defined on criticality

Criteria, scope, frequency and methods of reassessment defined

List of approved suppliers and scope of approval

5.6.1.2 Critical Suppliers Evaluation and Reevaluation (5.6.1.4, 5.6.1.5)

Critical Suppliers Sampled: Product / Component / Activity Performed:Check each requirement upon verification (explanation must be given for any blank boxes):

Site specific criteria

Reevaluation per 5.6.1.3

Records Maintained 5.6.1.5

Also verify: Risk assessment associated with product delivery includes supplier performance. Ensure risks are identified and controlled (5.3b).

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

Non - Critical Suppliers Sampled: Product / Component / Activity Performed:Check each requirement upon verification (explanation must be given for any blank boxes):

Initial and on-going capability assessment per 5.6.1.3

Records Maintained 5.6.1.5

Also verify: Risk assessment associated with product delivery includes supplier performance. Ensure risks are identified and controlled (5.3b).

5.6.1.6 Outsourced Activities

List all outsourced activities and processes (if applicable):


5.6.1.6 Outsourced ActivitiesControl of outsourced activities:

Records Maintained

Organizations applicable QMS requirements satisfied

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

Purchasing Information (5.6.2)Purchasing Information (include contracts/POs sampled -minimum of 3 :

Acceptance criteria documented

Records Maintained

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

Verification of Purchased Product / Activities (5.6.3)Verification of conformance to purchase requirements (include records reviewed as evidence of conformance):

Records Maintained

Also verify: - Controls for verification at suppliers premises, where applicable

Product Quality Plan(s) (as applicable)


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

Addresses each requirement of 5.7.2 (a) through (e)

Revisions documented / approved

Communicated

Production and Servicing Processes

Description of Production / Servicing Capabilities [What capabilities does the facility have (i.e., what are they capable of manufacturing?)] Reference all monogrammable and non-monogrammable products:

Description of Production and/or Servicing Processes (describe what manufacturing/servicing processes actually take place at the facility and interactions): Processes must be described in specific detail to provide information regarding the capabilities of the facility being audited. For example, production processes must be identified clearly as machining, assembly, welding, heat treatment, etc.; testing processes must be identified clearly as hydro-testing, nondestructive examination, etc.

Production / Servicing Processes reviewed/sampled:

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

Control of Production (5.7.1.1)Detail evidence observed (including records and documents reviewed, personnel interviewed, and processes observed) : Check each requirement upon verification (explanation must be given for any blank boxes):

Controls established and implemented for production:

Procedure as per 5.7.1.1

Design requirements/changes

Suitable equipment

Process control documents

Also verify: Implementation of Quality Plan, if required Work instructions, when applicable Monitoring & measuring activities Product release activities

Control of Servicing (if applicable)(5.7.1.2)Controls established and implemented for servicing:


Review of requirements

Suitable equipment

Identification/traceability

Process control documents

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

Process Control Documents(5.7.1.3)

Documentation of process controls:

Includes requirements for verifying conformance with quality plans, product specs, customer requirements

Reference instructions

Acceptance criteria

Also verify: Inspection holds and witness points

Product Realization Capability Documents(5.7.1.4)Product realization documentation sampled:

Product realization plan (5.2)

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

Acceptance criteria demonstrating capability

Validation of Processes for Production and Servicing(5.7.1.5)Validation of processes for production and services (including outsourced):

Demonstrates ability to achieve planned results

Verification of supplier conformance to standard requirements (5.6.1.6)

Records maintained

Records reviewed for processes requiring validation (select all that apply; enter additional records reviewed):

NDEWeldingHeat TreatmentOther:

Personnel QualificationWPSPersonnel Qualification

Equipment QualificationPQRProcedure/WIs

Work EnvironmentWPQFurnace Surveys

Procedure QualificationWelder Continuity Log

Personnel Qualifications

Equipment Qualification

Organizational Capability Work Environment (4.3.3)


Describe the work environment, including buildings, workspace and utilities; process equipment; supporting services; conditions under which work is performed.

Verify that the organization has determined, provided, manages, and maintains the work environment needed to achieve conformity applicable to the manufacture of the product(s).

Verify risk assessment associated with product delivery includes facility/equipment availability and maintenance. Ensure risks are identified and controlled (5.3a).

Identification and Traceability


Identification/ Traceability (5.7.3)

Identification / traceability reviewed / sampled:

Records maintained

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

Product Inspection / Test Status

Product Inspection / Test Status(5.7.4)

Records maintained indicating conformity / nonconformity of product

Customer-supplied Property (if applicable)

Customer-supplied Property (5.7.5)(if applicable)

Procedure per 5.7.5

Records maintained

Also verify:Requirements for reporting to customer

Preservation of Product


Preservation of Product (5.7.6.1)

Identification / traceability marks

Transportation, handling, packaging and protection

Records maintained

Storage and Assessment (5.7.6.2)

Designated storage area / stock rooms

Records of assessment maintained

Preventive Maintenance


Preventive Maintenance (5.7.8)Preventive maintenance for equipment used in product realization:

Procedure as per 5.7.8

Type of equipment, frequency, responsible personnel identified

Records maintained

Inspection and Testing

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

Inspection and Testing (5.7.7)In-process inspection and testing:


Inspection / testing at planned stages per plan / procedure

Evidence of conformity with acceptance criteria maintained

Final inspection and testing:


Final inspection / testing per plan / procedures

Evidence of conformity to requirements maintained

Product Release


Product Release(5.9)

Procedure as per 5.9

Release upon satisfactory completion of planned arrangements

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

Control of Testing, Monitoring and Measuring Equipment


Verify that the organization has determined the testing, monitoring, and measurement requirements and the associated equipment needed to ensure conformance.

Describe controls established and implemented to ensure that equipment is identified, calibrated, maintained, and used in a manner consistent with requirements. Also verify: Control of out-of tolerance equipment and assessment of previous measurements.

Equipment observed / sampled (minimum of 3):Note: For Monogram only, ensure that all inspection and testing requirements of the applicable product specification are addressedCheck each requirement upon verification (explanation must be given for any blank boxes):

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

Calibration status identified

Traceable to Natl/intl standard

Included on registry

Acceptance criteria defined and appropriate

Records maintained

Also verify: - Computer software confirmation- Externally provided equipment

Control of Nonconforming Product


Control of Nonconforming Product (5.10)

Procedure as per 5.10.1

Method of addressing non-conforming product per 5.10.2

Concession approved by relevant authority and/or customer

Customer notification per 5.10.4

Records maintained (5.10.5)

Also verify: Proper identification to prevent unintended use- Addressing the nonconformity- Identification, documentation, analysis and actions taken for nonconforming product identified after delivery- Risk assessment includes supplier performance. Ensure risks are identified and controlled (5.3b).

Management of Change


Describe the MOC process established by the facility. Verify that the MOC process has been established to ensure that integrity of the MS when changes are planned and implemented.

How does the facility identify potential risks associated with changes prior to making the change?

Verify that changes are approved as required prior to making changes.

Describe how the facility ensures that the MOC process is used for changes that may affect the QMS negatively, including changes: to the organizational structure; in key or essential personnel; in critical suppliers; and to MS processes, including changes resultingfrom CA / PA

Describe the organizations process for notification of changes. When is notification required? To who is notification required?

Identify process interaction / examples of Management of Change implementation: Check each requirement upon verification (explanation must be given for any blank boxes):

Negative affect(s) on QMS identified

Risks identified prior to change

Approved prior to change

Notification of change

Records maintained

Human Resources / Competence / Training Processes


4.2.2 Responsibility and Authority

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

4.3.2.2 Personnel Competence

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

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

4.3.2.3 Training and Awareness

Verify that the organization: provides for QMS training and job training; includes customer-specified and/or customer-provided training; identifies the frequency and content of training; ensure personnel are aware of the relevance and importance of their activities and how they contribute to the achievements of the quality objectives; and maintains appropriate records.

How does the facility identify training needs and ensure that personnel receive adequate training to address competency needs. What other methods has the facility used to address competency needs (outsourcing, process changes, etc.)?

Describe how the effectiveness of the actions are evaluated and maintained (i.e., competence evaluation) to ensure requirements are met.

Personnel Sampled for Competency and Training

NameTitleCompetency Defined / Record EvidencedTraining Record / Record EvidencedFinding#:

Supplemental Audit Information

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

Audit Package Checklist

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

QAR(s)**Findings (AARs)*Audit Plan

* If required**Please update as necessary

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