ISO 9001_2015 API Q1 Audit Checklist Template

(1)

Audit Checklist

Conforms to

(2)

Guidelines

1 Point / Percentage Scoring

1a

1b

1c

1d

Note that in the score there will not be any negative percentage, any negative will = 0%

1e

2 Score Banding

2a

2b

2c

3 Audit Fill Sheet

3a

General activity criteria questions

3b

3c

3d

3e

3f

3g

3h

3i

3j

3k

4 Rollup Details & Chart

4a

Would be the overall view of the results from all audit sheets and chart information

4b

Activities would be the quantity of criteria questions in the respective element

4c

Corrections quantity is the sum of minors and major findings count.

4d

All Minor and Major findings would require a formal CAR to be action for resolution and root cause identification

5 Other

5a

Time required to submit proposed corrective actions will follow the dates set.

5b

Audits are to preformed based on Risk

Low Risk - frequency of audit would be less

High Risk - frequency would be more

5c

Audit results are to be reviewed at Management Review meetings and follow up audits.

5d

Audit schedule will be planned and maintained using the audit plan and report

Observations: 1/2 point per occurrence - Example - 8 total questions in the section and 4 observations (

ob

)

were found (4

ob

X 1/2) = 2 and then divided by the total activities questions / 8 = 75% score.

Minor Finding: 3 points per occurrence - Example - 8 total questions in the section and 2 minor (

mi

) were found

(2

mi

X 3) = 6 and then divided by the total activities questions / 8 = 25% score.

Major Finding: 10 points per occurrence - Example - 8 total questions in the section and 1 major (

ma

) was

found (1

ma

X 10) = 10 and then divided by the total activities questions / 8 = 0% score.

Note that

ob

,

mi

and

ma

are tallied in the total score divide by the activities for the result % Compliant

86 - 100% (Green)

- Exceed Expectations – requires continual improvements of the processes towards a Error

Free system and operating in a preventive work environment

71 - 85% (Amber)

- Meets Expectations - requires minor improvements and continue to work the system with

targets and actions to get this into the green.

0 - 70% (Red)

- Below Expectations - requires major improvements and continuous management attention to

re-planning along with strong targets and initiatives to get this into the green.

Make comments of issues and non-evidence found under the criteria questions, this is pre-formatted in blue.

In the comply level column, a result must be with a - yes,

ob

,

mi

or

ma

. Only not applicable na could be used in

facility were design is not a function of the work scope. NA will not tally in the score.

A yes,

ob

,

mi

or

ma

result has been conditionally formatted.

Yes (yes) - evidence is present with full compliance at all times with evidence of preventive measures showing

continual improvement.

Observations (ob) - evidence is present, however some discipline and commitment to fully comply at all times

would indicate some additional preventive measures would bring this in a continual improvement process.

Minor (mi) - would indicate some evidence and a process is present, however not working the workflow to the

documentation process, requires a CAR to rectify. (A minor on the check sheet will be noted as a "finding" on the

report.

Major (ma) - would indication no evidence, ignoring the process, complete lack of commitment or a complete

system area collapse, requires total management commitment along with a CAR to rectify. ( A major on the check

sheet will be noted as a "finding" on the report.

Responsible party would be the individual which will be the action leader to resolve the finding. Do not use function

or group must have accountability.

Correction target date would be the planned date for the finding being resolved.

Date corrected would be the date the finding would be actually resolved.

Observations (

ob

) - Not required but advised

Minor (

mi

) - 14 days

(3)

(4)

Business Unit - Full Audit System Checklist

No.

Audit Area

Activities

Observations

Minor

Major

% Complaint

Audit Score

1

19

3

16

3

15

0

18 44.7%

2219.0%

2

57

16

39

2

51

0

53 75.4%

5017.9%

3

0

18

0

18

0

18 NA

NA

4

15

7

18

0

25

1

24 10.0%

2400.0%

5

104

26

168

2

192

0

194 81.7%

13684.2%

6

67

17

61

7

68

0

75 56.0%

3337.3%

Totals

262

69

320

14

369

1

382 67.0%

5880.9%

Before

Correction

After

Correction

Before

Correction

After

Correction

Before

Correction

After

Correction

Score

Quality Management System

Management Responsibility

Risk Management

Resource Management

Product & Service Realization

Measurement, Analysis and Improvement

Quality Management

System

Management

Responsibility

Risk Management

Resource Management

Product & Service

Realization

Measurement, Analysis

and Improvement

0.0%

2000.0%

4000.0%

6000.0%

8000.0%

10000.0%

12000.0%

14000.0%

16000.0%

45%

75%

10%

82%

56%

2219%

5018%

2400%

13684%

3337%

% Compliant (Audit Score) % Compliant (Correction Score) Total Audit Score Total Correction Score

86 - 100%

71 - 85%

0 - 70%

Scoring

(5)

Opportunity for Improvement

$0 0

OFI# DATE LOCATION FROM CATEGORY DETAILS POSSIBLE ROOT CAUSES POSSIBLE SOLUTIONS COMMENTS

Total OFI Value Improvement

[$] Total No. of OFI Submissions

PONC IMPROVEMENT

(6)

General Observation

0

GOB# DATE LOCATION FROM CATEGORY DETAILS RESPONSIBLE PARTY CORRECTED DATE PHOTO

Total No. of General Observation(s)

CORRECTIVE ACTION

(7)

RESPONSIBLE PARTY

1.1

API 4.2.1 *Requirement: The organization shall establish a documented and implemented QMS. MI

*Requirement: The QMS shall include documented evidence of statements of the quality policy and applicable objectives.

yes

ob *Requirement: The QMS shall include evidence of provisions for continual improvement.

yes

*Requirement: The QMS shall include provisions to communicate performance measures to everyone in the organization.

yes

Requirement: The QMS shall include quality records required by the standards.

yes 1.2

yes

mi

Quality Management System

COMPLY LEVEL TARGET DATECORRECTION CORRECTEDDATE

General QMS Requirements- Does the quality management system include:

ISO/API 5.2.1 & 6.2/4.1.3 ISO/API

4.1

*Requirement: The organization shall determine the processes needed for the QMS and their application throughout the organization, determine the sequence and interaction of these processes. The organization shall determine external and internal issues that are relevant to its purpose and it's strategic direction and that affect its ability to achieve the intended results of its QMS (Context)

ISO 4.2

Requirement: The organization shall determine the interested parties that are relevant to the QMS and the requirements of the interested parties. The organization shall monitor and review this information.

ISO/API 4.4.1/4.3.1 ISO/API 7.4/4.1.5 ISO/API 7.5.1/4.5

Quality Manual - Does the quality manual include: Obtain copy or review Doc. #

ISO/API 4.2/4.4.1

**Requirement: The Quality Manual shall include the manner in which the organization addresses each specific requirement of the applicable technical specification. (Includes legal (statutory and regulatory) and other applicable requirements to which the organization claims compliance that are needed to achieve product conformity)

ISO/API 4.3/4.4.1

**Requirement: The Quality Manual shall include the scope of the quality management system including details of and justification for exclusions.

(8)

Quality Management System

COMPLY LEVEL TARGET DATECORRECTION CORRECTEDDATE

1.3

ob

Requirement: The Control of Documents Procedure shall address how documents are reviewed, updated, and re-approved.

yes

Requirement: The Control of Documents Procedure shall address the status of changes and revisions.

mi Requirement: The Control of Documents Procedure shall address relevant versions are available where the activity is being pe

ob

Requirement: The Control of Documents Procedure shall address how documents are to be legible and readily identifiable.

yes

Requirement: The Control of Documents Procedure shall address how external documents are identified, and their distribution i

yes

Requirement: The Control of Documents Procedure shall address how obsolete documents are not used by mistake and are ident

yes 1.4

yes

Requirement: The Control of Records Procedure shall address how quality records are to be legible and retrievable.

yes yes Control of Documents - (Documented Information) Is there a documented procedure requiring that: Review Doc. #

ISO/API 7.5.2/4.4.3

Requirement: The Control of Documents Procedure shall address changes to documents to be reviewed and approved prior to issue and use.

ISO/API 7.5.2/4.4.3 ISO/API 7.5.2/4.4.3 ISO/API 7.5.3/4.4.3 ISO/API 7.5.3/4.4.3 ISO/API 7.5.3/4.4.4 ISO/API 7.5.3/4.4.3

Control of Quality Records (Retained documented information) Doc # Retention List Doc #

ISO/API 7.5.3/4.5

The Control of Records Procedure shall address how quality records, including those originating from outsourced activities, are maintained and controlled to provide evidence of conformity to requirements and the effective operation of the QMS. ISO/API

7.5.3/4.5 ISO/API 7.5.3/4.5

Requirement: The Control of Records Procedure shall address a documented procedure defining the controls needed for the identification, collection, storage, protection, retrieval, retention time and disposition of quality.

(9)

Business Unit - Full Audit System

1 Activities

Observations

Minor

Major

% Compliant

Audit Score

1.1 General

7

1

6

1

5

0

6 50.0%

2228.6%

1.2 Quality Manual

2

0

2

1

0

2 0.0%

800.0%

1.3 Control of Documents

7

2

5

1

6

0

7 42.9%

2262.5%

1.4 Control of Quality Records

3

0

3

0

3

0

3 100.0%

#DIV/0!

Totals

19

3

16

3

15

0

18 44.7%

2219.0%

Quality Management System

Before

Correction

After

Correction

Before

Correction

After

Correction

Before

Correction

After

Correction

Score

General

Quality Manual

Control of Documents

Control of Quality Records

0.0%

500.0%

1000.0%

1500.0%

2000.0%

2500.0%

50%

0%

43%

100%

2229%

800%

2263%

45%

2219%

86 - 100%

71 - 85%

0 - 70%

Scoring

(10)

2.1

Requirement: Taking accountability for the effectiveness of the QMS

yes yes

*Requirement: Ensuring the integration of the QMS into the organization's business processes.

yes

*Requirement: Promoting the use of the process approach and risk-based thinking.

ob Requirement: Ensuring the resources needed for the effective implementation of the QMS are available.

mi Requirement: Communicating the importance of effective quality management and of conforming to the QMS requirements.

yes

Requirement: Ensuring the QMS achieves its intended results. (Also see Management Review)

yes

Requirement: Engaging, directing and supporting persons to contribute to the effectiveness of the QMS.

yes

Requirement: Promote improvement.

ob

Requirement: Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

yes yes 2.2

*Requirement: Customer and applicable statutory and regulatory requirements are determined, understood and consistently met.

yes

ob

Requirement: The focus on enhancing customer satisfaction is maintained.

yes 2.3

**Requirement: Top management shall approve a documented Quality Policy.

yes

Requirement: Is appropriate to the purpose and context of the organization and supports its strategic direction.

yes yes

Requirement: The Quality Policy shall include a framework for establishing and reviewing quality objectives.

yes yes

Requirement: The Quality Policy shall be reviewed for continuing suitability. (See Management Review)

yes 2.4

Management Responsibility

COMPLY

LEVEL TARGET DATECORRECTION CORRECTEDDATE

Management / Leadership commitment - Top management shall demonstrate leadership and commitment with respect to the QMS by:

ISO/API 5.1/4.2 ISO/API

5.1/4.2

Requirement: Ensuring the quality policy and quality objectives are established including KPIs for use in data analysis for the QMS and are compatible with the context and strategic direction of the organization.

ISO/API 5.1/4.2 ISO/API 5.1/4.2 ISO/API 5.1/4.2-4.3 ISO/API 5.1/4.2 ISO/API 5.1/4.2 ISO/API 5.1/4.2 ISO/API 5.1/4.2 ISO/API 5.1/4.2 ISO/API

5.1/4.2.1 Requirement: Defining and documenting responsibilities, authorities and accountabilities of personnel and communicate throughout the organization.

Customer Focus - Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:

ISO/API 5.1.2/4.1.5

*Requirement: The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed.

ISO/API 5.1.2/4.1.5

Quality Policy - Top management shall establish, implement and maintain a quality policy that:

ISO/API 5.2/4.1.2 ISO/API 5.2/4.1.2 ISO/API 5.2/4.1.2

Requirement: The Quality Policy shall include a commitment to comply with requirements and will continue to improve the effectiveness of the QMS.

ISO/API 5.2/4.1.2

Requirement: Is available and maintained as documented information (record); be communicated, understood and applied within the organization; be available to relevant interested parties, as appropriate.

ISO/API 5.2/4.1.2

(11)

Management Responsibility

COMPLY

yes

Requirement: Quality objectives shall be measurable and consistent with the quality policy.

yes

ob

2.5

yes

Requirement: When planning the QMS does top management take actions to address risk and opportunities?

ob

Requirement: When the organization determines the need for changes to the QMS, the changes shall be carried out in a planned manner.

yes

ISO/API 6.2/4.1.3

Requirement: Top management shall ensure quality objectives, including those needed to meet requirements for the product, are established at relevant functions and levels within the organization to enhance customer satisfaction.

ISO/API 6.2/4.1.3

Requirement: Quality objectives shall be measurable; be measurable; be communicated; be updated, as appropriate and documented information (records) maintained.

Quality management system planning -

ISO/API 5.4.2/4.1.4

Requirement: Does top management ensure that criteria and methods needed for the operation and control of all QMS processes are determined, management and effective and planning of the QMS is carried out in order to meet the requirements of the standards? ISO/API

6.1/5.11 ISO

(12)

Management Responsibility

COMPLY

2.6 Management representative/Organizational roles, responsibilities and authorities

yes yes yes yes

ob

2.7 Internal / External communication

yes yes 2.8 Management review Doc #

Requirement: Top management shall review the QMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.

mi ** Top management must conduct an annual management review.

yes

ob

Requirement: Records from management reviews shall be maintained.

yes 2.9

Requirement: Effectiveness and status of actions taken from previous management review.

yes

Requirement: Changes in external and internal issues that are relevant to the QMS

ob

Requirement: Status of corrective and preventive actions

ob

Requirement: Changes that could affect the QMS, including changes to legal and other applicable requirements (e.g. industry standards)

ob

Requirement: Analysis of customer satisfaction and feedback from relevant interested parties

yes

Requirement: The extent to which quality objectives have been met

yes

Requirement: Analysis of supplier performance

yes

Requirement: Review and analysis of product conformity, including nonconformances identified after delivery and use

yes

Requirement: Results of audits

yes

Requirement: Process performance

yes

ISO/API 5.5.2/4.2.3

Requirement: Top management shall appoint a member of management who, irrespective of other responsibilities, will have responsibility and authority.

ISO/API 5.5.2/4.2.3

Requirement: The appointed member of management shall ensure processes needed for the QMS are established, implemented, maintained and conforms to the requirements of the applicable standards.

ISO/API 5.5.2/4.2.3

Requirement: The appointed member of management shall reports to top management on the performance and needed improvements of the QMS.

ISO/API 5.5.2/4.2.3

Requirement: The appointed member of management shall ensure customer requirements are made aware and are promoted throughout the organization.

ISO/API 5.5.2/4.2.3

Requirement: The appointed member of management shall ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

ISO/API 7.4/4.1.5

Top management shall ensure appropriate communication processes are established and communicated regarding the effectiveness of the QMS including on what, when, with whom, how to and who communicates.

ISO/API 7.4/4.1.5

Have processes been established to ensure that the importance of meeting customer, legal, results of analysis of data, and other applicable requirements been communicated at relevant functions within the organization.

ISO/API 9.3/6.5 API 6.5 API 6.5

Requirement: The management review shall include assessment of opportunities for improvement and needed changes to the QMS including the policy and objectives.

ISO/API 9.3/6.5

Review Input - Does the input to management review include: Doc. #

ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2

(13)

Management Responsibility

COMPLY

LEVEL TARGET DATECORRECTION CORRECTEDDATE Requirement: Inputs to the management review shall include results of risk assessments.

ob

Requirement: The adequacy of resources

ob

Requirement: Opportunities and recommendations for improvement.

ob

2.10

Requirement: Assessment of the effectiveness of the QMS and any needed or required changes including decisions and required actions

ob

Requirement: Improvement made to products and to customer requirements.

ob

Requirement: Needed resources.

yes

Requirement: Opportunity for improvement.

yes

Requirement: Approved by top management and documented information retained.

yes ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2

Review output - Does the output from the management review include any decisions and actions related to:

ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2

(14)

Business Unit - Full Audit System

2 Activities

Observations

Minor

Major

% Compliant

Audit Score

2.1 Management Commitment

11

2

9

1

0

10 63.6%

2612.5%

2.2 Customer Focus

2

1

0

2

0

2 75.0%

5300.0%

2.3 Quality Policy

6

0

6

0

6

0

6 100.0%

#DIV/0!

2.4 Quality Objectives

3

1

2

0

3

0

3 83.3%

8000.0%

2.5 QM System Planning

3

1

2

0

3

0

3 83.3%

8000.0%

2.6 Management Representative

5

1

4

0

5

0

5 90.0%

13400.0%

2.7 Internal Communication

5

1

2

0

2

0

2 90.0%

5400.0%

2.8 Management Review

4

1

3

1

3

0

4 12.5%

1442.9%

2.9 Review Input

13

6

7

0

13

0

13 76.9%

5750.0%

2.10 Review Output

5

2

3

0

5

0

5 80.0%

6650.0%

Totals

57

16

39

2

42

0

53 75.4%

4825.0%

Management Responsibility

Before

Correction

After

Correction

Before

Correction

After

Correction

Before

Correction

After

Correction

Score

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

120.0%

64%

75%

100%

83%

90%

13%

77%

80%

2613%

5300%

8000%

13400%

5400%

1443%

5750%

6650%

75%

4825%

% Complaint (Audit Score) % Complaint (Correction Score) Total Audit Score Total Correction Score

86 - 100%

71 - 85%

0 - 70%

Scoring

(15)

Risk Management

3.1 Risk Identification

na

Requirement: Risk assessment associated with product delivery shall include facility/equipment availability and maintenance.

na

Requirement: Risk assessment associated with product delivery shall include supplier performance and material availability/supply.

na

Requirement: Risk assessment associated with product quality shall include, as applicable: Delivery of nonconforming product.

na

Requirement: Risk assessment associated with product quality shall include, as applicable: Availability of competent personnel.

na

3.2 Contingency Planning

na

Requirement: The Contingency Planning Procedure shall address identification and assignment of responsibilities and authorities.

na

Requirement: The Contingency Planning Procedure shall address: Internal and External communication controls.

na

Requirement: The Contingency Planning Procedure shall address: How outputs are documented, communicated and addressed.

na

3.3 Management of Change

Requirement: A Management of Change process shall be established by the organization.

na

COMPLY

LEVEL CORRECTION TARGET DATE CORRECTEDDATE

ISO/API 6.1/5.3

*Requirement: A system shall be in place to identify risks associated with the techniques, tools and their application for risk identification, assessment, and mitigation of the risk, manage the risks to acceptable levels and to be explained and understood by all employees.

How is this being done? Evidence: Finding: ISO/API 6.1/5.3 Evidence: Finding: ISO/API 6.1/5.3 Evidence: Finding: ISO/API 6.1/5.3 Evidence: Finding: ISO/API 6.1/5.3 Evidence: Finding: ISO/API 6.1/5.3

Requirement: What type of records are maintained as a result of assessment and management of the product and processes including actions taken?

Evidence: Finding:

ISO/API 6.1.2/5.5

Requirement: A Contingency Planning Procedure shall be implemented to address the risk associated with the impact on delivery and quality of the product. Evidence: Finding: ISO/API 6.1.2/5.5. 2

Requirement: The Contingency Planning Procedure shall address actions required in response to significant risk scenarios to mitigate effects of disruptive incidents. Evidence: Finding: ISO/API 6.1.25.5.2 Evidence: _Finding: ISO/API 6.1.2/5.5. 2 Evidence: Finding: ISO/API 6.1.2/5.5. 2 Evidence: Finding: ISO/API 6.1.2/5.11 (8.5.6)

Verify knowledge and understanding of the requirement Evidence:

Finding:

ISO/API 6.1.2/5.11

Requirement: The MOC process shall address processes that may negatively impact the quality of the product and changes in the organizational structure.

Verify in-process or completed MOCs for organizational structure. Evidence:

Finding:

ISO/API 6.1.2/5.11

Requirement: The MOC process shall address processes that may negative impact the quality of the product and changes in key or essential personnel.

(16)

Risk Management

COMPLY _LEVEL RESPONSIBLE PARTY CORRECTION _{TARGET DATE} _CORRECTEDDATE

na

Requirement: The MOC process shall address processes that may negative impact the quality of the product and changes in critical suppliers.

na

3.4 MOC Notification

na

Requirement: Records of MOCs shall be maintained and stored.

na

ISO/API

6.1.2/5.11Verify in-process or completed MOCs for changes in key or essential personnel.

Evidence: Finding:

ISO/API

6.1.2/5.11Verify in-process or completed MOCs for changes in critical suppliers.

Evidence: Finding:

ISO/API 6.1.2/5.11

Requirement: The MOC process shall address processes that may negative impact the quality of the product and changes in the management system including changes resulting from corrective and preventive actions.

Verify in-process or completed MOCs for changes in the management system. Evidence:

Finding:

API 5.11

Requirement: Relevant personnel, including the customer when required, shall be notified of changes in residual or new risks due to changes that have been initiated by the facility or requested by the customer.

Verify the relevant personnel were notified of changes. Evidence:

Finding:

ISO/API

Totals

0

18

0

18

0

18 NA

NA

Risk Management

Before

Correction CorrectionAfter CorrectionBefore CorrectionAfter CorrectionBefore CorrectionAfter Correction Score

Risk Identification Hazard Control Management of Change Achievement of Objectives

0.0% 200.0% 400.0% 600.0% 800.0% 1000.0% 1200.0%

86 - 100%

71 - 85%

0 - 70%

(18)

4.1 ###

### yes

###

*Requirement: The organization shall consider the capabilities of, and constraints on, existing internal resources

yes

###

Requirement: The organization shall consider what needs to be obtained from external providers.

yes

### yes

4.2 ###Human Resources - General

###

*Requirement: Job responsibilities shall be developed and verified with each employee.

yes

### ob

4.3 ###Competence, Awareness and Training

###

ma

###

**Requirement: Training needs and the frequency of training shall be identified and provided including IMS and specific job skills.

ob ###

Requirement: Training or other actions shall be provided to satisfy the needs of the QMS.

ob ###

Requirement: The effectiveness of training shall be evaluated.

ob ###

Requirement: Personnel shall be made aware of the quality policy and relevant quality objectives.

ob

### ob

###

Requirement: Appropriate records shall be maintained of education, training, skills and experience for all employees.

ob

4.4 ###Environment for the operation of processes

### yes

4.5 ###Work environment - Infrastructure

###

Requirement: The work environment shall be managed to achieve conformity to product requirements.

na

Resource Management

COMPLY LEVEL TARGET DATECORRECTION

Provision of resources - Organizational Knowledge

ISO/API 7.1/4.3.1

*Requirement: The organization shall determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the QMS.

ISO/API 6.14.1/4.3.1 ISO/API 6.14.1/4.3.1 ISO 7.1.6

Requirement: The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This Knowledge shall be maintained and be made available to the extent necessary.

ISO 7.1.6

Requirement: When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.

API 4.3.2 ISO 7.1.2

Requirement: The organization shall determine and provide the persons necessary for the effective implementation of its QMS and for the operation and control of its processes.

ISO/API 7.2/4.3.2.3

*Requirement: The organization shall determine the necessary competence of person(s) doing work under its control that affect the performance and effectiveness of the QMS. Personnel shall be competent based on the appropriate education, training, skills, and experience needed to meet product and customer requirements. Evidence of the determination of competence of personnel shall be recorded and maintained.

ISO/API 6.2.2/4.3.2.3 ISO/API 7.2/4.3.2.3 ISO/API 7.2/4.3.2.3 ISO/API 7.3/4.3.2.3 ISO/API 7.3/4.3.2.3

Requirement: Personnel shall be made aware of the relevance and the importance of their activities and how they contribute to the achievement of the quality objective and the implications of not conforming with the QMS.

ISO/API 7.2/4.3.2.3

ISO 7.1.3

Requirement: The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of product and services.

ISO/API 7.1.4/4.3.3

(19)

DATE CORRECTED

(20)

Business Unit - Full Audit System

4 Activities

Observations

Minor

Major

% Compliant

Audit Score

4.1 Provision of Resources

5

0

5

0

5

0

5 100.0%

#DIV/0!

4.2 Human Resources - General

2

1

0

2

0

2 75.0%

5300.0%

4.3 Competence, Awareness and Training

7

6

1

0

7

1

6 0.0%

626.9%

4.4 Environment

1

0

1

0

1

0

1 100.0%

#DIV/0!

4.5 Work Environment

0

5

0

5

0

5 NA

NA

4.6 Preventive Maintenance

0

5

0

5

0

5 NA

NA

Totals

15

7

18

0

25

1

24 10.0%

2400.0%

Resource Management

Before

Correction

After

Correction

Before

Correction

After

Correction

Before

Correction

After

Correction

Score

Provision of Resources

Human Resources -

General

Competence, Awareness

and Training

Environment

Work Environment

Preventive Maintenance

0.0%

1000.0%

2000.0%

3000.0%

4000.0%

5000.0%

6000.0%

100%

75%

0%

100%

5300%

627%

10%

2400%

% Complaint (Audit Score) % Complaint (Correction Score) Total Audit Score Total Correction Score

86 - 100%

71 - 85%

0 - 70%

Scoring

(21)

RESPONSIBLE PARTY 5.1 Planning of Product Realization Doc. #

yes

Requirement: Planning shall be conducted and documented by the organization to address product and customer-specified requirements.

yes

Requirement: Planning by the organization shall address: Legal and other applicable requirements.

yes

Requirement: Planning by the organization shall address: Contingencies based on risk assessment.

ob Requirement: Planning by the organization shall address: Design and Development.

yes yes

Requirement: Planning by the organization shall address: Management of Change.

yes yes

5.2

Requirement: Requirements specified by the customer.

yes

Requirement: Legal and other applicable requirements.

yes

Requirement: Requirements not stated by the customer but considered necessary by the organization for the provision of the product

yes yes

5.3 Review of requirements related to the product

*Requirement: A standardized contract review process shall be developed and implemented.

yes yes

Requirement: Requirements specified by the customer are identified and documented including delivery and post delivery activity.

yes

Requirement: Requirements differing from those previously identified are resolved

yes

Requirement: The organization has the capability to met the documented requirements.

yes yes

Requirement: Records of the results of the review, including resulting actions, shall be maintained.

yes

Requirement: Statutory and regulatory requirements applicable to the product and services

yes yes

Product & Service Realization

COMPLY _LEVEL CORRECTION

TARGET DATE CORRECTEDDATE

ISO/API 8.1/5.2

Requirement: A process shall be developed and in place for product realization consistent with the requirement of the other processes of the QMS.

ISO/API 8.1/5.2

Requirement: Planning shall be conducted and documented by the organization to address required resources and work environment management. ISO/API 8.1/5.2 ISO/API 8.1/5.2 ISO/API 8.1/5.2 ISO/API 8.1/5.2 ISO/API 8.1/5.2

Requirement: Planning by the organization shall address: Required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance.

ISO/API 8.1/5.2 ISO/API

8.1/5.2

Requirement: Planning by the organization shall address: Records needed to provide evidence that the product realization process meets the requirement.

Contract Review - Determination of requirements related to the product - The organization shall determine: ISO/API 8.2.2/5.1.2 ISO/API 8.2.2/5.1.2 ISO/API 8.2.2/5.1.2 ISO/API 8.2/5.1.2

Requirement: Where the customer provides no documented statement of the requirement, the customer requirements shall be confirmed by the organization and records maintained.

ISO/API 8.2.3/5.1.3 ISO/API 8.2.3/5.1.3

Requirement: The organization shall review the requirements related to provision of products. The review shall be conducted prior to the organization's commitment to deliver product to the customer and shall ensure…

ISO/API 8.2.3/5.1.3 ISO/API 8.2.3/5.1.3 ISO/API 8.2.3/5.1.3 ISO/API 8.2.3/5.1.3

Requirement: Where contract requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

ISO/API 8.2.3/5.1.3 ISO/API 8.2.3/5.1.3 ISO/API 8.2.4/5.1.3

Requirement: When product requirements are changed, the business unit shall ensure relevant documents are amended, and relevant personnel is made aware of the changed requirements.

(22)

Product & Service Realization

TARGET DATE CORRECTEDDATE 5.4 Customer Communication

*Requirement: A process shall be developed and implemented for communicating NOV facility's successes to our customers.

yes

Requirement: Effective arrangements for communicating with customers shall be made in relation to product information.

yes yes yes

yes

5.5 Design and development planning

Requirement: The organization shall maintain a documented procedure to plan and control the design and development of the product. _yes Requirement: The requirements for a final review of the design shall be determined.

yes

Requirement: The procedure shall identify the plan(s), including plan updates, used for design development.

yes yes yes

yes yes

Requirement: The procedure shall identify the final review of the design

yes

Requirement: The level of control expected for the design and development process by customers and relevant interested parties.

yes

na

yes

Requirement: The documented information (records) needed to demonstrate that design and development requirements have been met.

yes

5.6

**Requirement: Product design inputs shall be identified, documented reviewed for adequacy and lack of conflict.

yes

**Requirement: Product design inputs shall include customer specified requirements.

yes

Requirement: Product design input requirements shall be provided from external sources, including API product specifications.

yes

Requirement: Applicable legal, statutory and regulatory product input requirements shall be determined and documented.

yes yes ISO/API 8.2.1/4.1.5.2 ISO/API 8.2.1/4.1.5.2 ISO/API 8.2.1/4.1.5.2

Requirement: Effective arrangements for communicating with customers shall be made in relation to inquiries, contracts or order handling, including amendments.

ISO/API 8.2.1/4.1.5.2

Requirement: Effective arrangements for communicating with customers shall be made in relation to Customer feedback, including customer complaints.

ISO/API 8.2.1/4.1.5.2

Requirement: Effective arrangements for communicating with customers shall be made when required by contract to provide information required by product quality plans and subsequent changes to those plans. Establishing specific requirements for contingency plans, when relevant. ISO/API 8.3.2/5.4.1 ISO/API 8.3.2/5.4.1 ISO/API 8.3.2/5.4.1 ISO/API 8.3.2/5.4.1

Requirement: The procedure shall identify the design and development stages including reviews. The organization shall also consider the nature, duration and complexity of the design and development activities.

ISO/API 8.3.2/5.4.1

Requirement: The procedure shall identify the internal and external resources, responsibilities, authorities, and their interfaces to ensue effective communication.

ISO/API 8.3.2/5.4.1

Requirement: The procedure shall identify the review, verification, and validation activities necessary to complete each design and development stage

ISO/API 8.3.2/5.4.1

Requirement: The need for involvement of customers and users in the design and development process and the requirements for subsequent provision of products and services.

ISO/API 8.3.2/5.4.1 ISO/API 8.3.2/5.4.1 ISO/API 8.3.2/5.4.1

Requirement: When the design and development activities are performed at different locations within the same organization, the procedure shall identify the controls required to ensure that the designs meet the requirements stated above.

ISO/API 8.3.2/5.4.1

Requirement: When design and development are outsourced, the organization shall ensure the supplier meets the requirements outlined in purchasing.

ISO/API 8.3.2/5.4.1

Design and development inputs - Are there records of inputs relating to product requirements that include: ISO/API 8.3.3/5.4.2 ISO/API 8.3.3/5.4.2 ISO/API 8.3.3/5.4.2 ISO/API 8.3.3/5.4.2 ISO/API 8.3.3/5.4.2

Requirement: Historical performance inputs where applicable, information derived from previous similar designs shall be determined and documented.

(23)

Product & Service Realization

yes

Requirement: Other inputs and requirements essential for design and development of the product shall be determined and documented.

yes yes

Requirement: Results from risk assessments (See risk section)

ob Requirement: Records of product design inputs shall be maintained.

yes ISO/API 8.3.3/5.4.2 ISO/API 8.3.3/5.4.2 ISO/API 8.3.3/5.4.2

Requirement: Methodology, assumptions, and formulae documentation shall be determined and documented for product design and development. (Functional and performance requirements). Potential consequences of failure due to the nature of the product and services shall be considered.

ISO/API 8.3.3/5.4.2 ISO/API 8.3.3/5.4.2

(24)

Product & Service Realization

TARGET DATE CORRECTEDDATE 5.7 Design and development outputs

yes

Requirement: Provide appropriate information for purchasing production and servicing.

yes

Requirement: Identify or reference design acceptance criteria (DAC)

yes

Requirement: Include identification of, or reference to, products and/or components deemed critical to the design

yes

Requirement: Include results of applicable calculations _yes

Requirement: Specify the characteristics of the product that are essential for its safe and proper use.

yes

Requirement: Records of the design outputs shall be maintained.

yes

5.8 Design and Development Review

**Requirement: The final design review shall be conducted, documented and approved by someone who did not develop the design.

mi ob Requirement: The systematic review shall identify any problems and propose necessary actions.

ob Requirement: Representatives of functions concerned with the design and development stage review shall be included.

ob Requirement: Records of the results of the reviews and any necessary actions shall be maintained.

ob 5.9 Design and Development Verification

Requirement: Verification shall be performed to ensure design and development outputs satisfy the design and development input requirements

yes

Requirement: Records of the results of the verification and any necessary actions shall be maintained.

yes

5.10 Design and Development Validation and Approval

yes

Requirement: Validation shall be completed prior to the delivery or implementation of the product when possible.

yes

Requirement: Records of the results of validation and any necessary actions shall be maintained.

yes

Requirement: The completed design shall be approved after validation.

yes

Requirement: Final approval of the design shall be completed by competent individual(s) independent of the person(s) who developed the desi

yes

Requirement: Records of design and development validation, approval, and necessary actions shall be maintained.

yes

ISO/API 8.3.5/5.4.3

Requirement: Outputs of design and development shall be documented in a form that enables verification to the design and development inputs. ISO/API 8.3.5/5.4.3 ISO/API 8.3.5/5.4.3 ISO/API 8.3.5/5.4.3 ISO/API 8.3.5/5.4.3 ISO/API 8.3.5/5.4.3 ISO/API 8.3.5/5.4.3 ISO/API 8.3.4/5.4.4 ISO/API 8.3.4/5.4.4

Requirement: Systematic reviews shall be conducted and shall evaluate the ability of the design and development activity to fulfill requirements. ISO/API 8.3.4/5.4.4 ISO/API 8.3.4/5.4.4 ISO/API 8.3.4/5.4.4 ISO/API 8.3.4/5.4.5 ISO/API 8.3.4/5.4.5 ISO/API 8.3.4/5.4.6

Requirement: Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of fulfilling the requirements for the specified or known intended use or application.

ISO/API 5.4.6 ISO/API 5.4.6 ISO/API 5.4.6 ISO/API 5.4.6 ISO/API 8.3.4/5.4.6

(25)

Product & Service Realization

TARGET DATE CORRECTEDDATE 5.11 Design and Development Changes

**Requirement: Design and development changes shall have the same controls as the original design.

yes

Requirement: Design and development changes shall be identified, authorized and records shall be maintained.

yes

Requirement: Changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.

yes yes

Requirement: Records of the results of the review of changes and any necessary actions shall be maintained.

yes

5.12 Purchasing - Control of externally provided resources, product and services

ob Requirement: Purchased products shall conform to specified requirements.

na mi

Requirement: The determination of criticality of activities or products as applicable to conformance of product or customer specifications.

yes

ob Requirement: The type and extent of control applied to the supplier based on the criticality of the product or activity. _ob Requirement: The criteria, scope, frequency, and methods for a reassessment of suppliers. _ob Requirement: The facility shall maintain a list of approved suppliers and scope of approval. _ob Requirement: The type and extent of control to be applied to outsourced activities. _ob ob ob ob ob ob ob ob ISO/API 8.3.6/5.4.7 ISO/API 8.3.6/5.4.7 ISO/API 8.3.6/5.4.7 ISO/API 8.3.6/5.4.7

Requirement: Review of design and development changes shall include evaluation of the effect of the changes on constituent parts and delivered product and actions taken to prevent adverse impacts.

ISO/API 8.3.6/5.4.7 ISO/API 8.4.1/5.6.1

Requirement: A process shall be developed and implemented to ensure purchased product or outsourced activities conform to specific requirements for procured goods and services.

ISO/API 8.4.1/5.6.1 ISO/API 8.4.1/5.6.1

Requirement: The type and extent of controls applied to the supplier, and to the purchased products, shall depend on the effect of the purchased product on subsequent product realization or the final product. Including product or services provided directly to the customer(s) by external providers on behalf of the organization.

ISO/API 8.4.1/5.6.1 ISO/API 8.4.1/5.6.1.1

Requirement: The initial evaluation and selection of suppliers based on their ability to supply products or activities in accordance with the organization's requirements. ISO/API 8.4.2/5.6.1 ISO/API 8.4.2/5.6.1 ISO/API 8.4.2/5.6.1 ISO/API 8.4.2/5.6.1 ISO/API 8.4.2/5.6.1

Requirement: The Initial Supplier Evaluation - For purchases of critical products, components or activities, the criteria for the initial evaluation of suppliers by the organization shall be site-specific for each supplier and shall include below.

ISO/API 8.4.2/5.6.1

Requirement: The Initial Supplier Evaluation - Critical Purchases shall include the verification that the supplier's quality management system conforms to the quality system requirements specified for supplier's by the organization.

ISO/API 8.4.2/5.6.1

Requirement: The Initial Supplier Evaluation - Critical Purchases shall include the assessment of the supplier to ensure the capability to meet the desired purchasing requirements.

ISO/API 8.4.2/5.6.1

Requirement: The Initial Supplier Evaluation - Critical Purchases shall include: Assessment of the supplier by performing an on-site evaluation of relevant activities.

ISO/API 8.4.2/5.6.1.2

Requirement: The Initial Supplier Evaluation - Critical Purchases shall include: Assessment of the supplier by performing first article inspection to ensure conformance to stated requirements.

ISO/API 8.4.2/5.6.1.2

Requirement: The Initial Supplier Evaluation - Critical Purchases shall include: Identifying how the supplied product conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements?

ISO/API 8.4.2/5.6.1.2

Requirement: The Initial Supplier Evaluation - Noncritical Purchases shall include: Verification of the supplier's quality management system conforms to the quality system requirements specified for supplier's by the organization?

(26)

Product & Service Realization

ob

ob ob

ob Requirement: Critical and Noncritical suppliers shall be reevaluated following 5.6.1.3 _ob Records of all evaluations and actions arising from evaluations shall be maintained. _ob

Requirement: A list of outsourced activities shall be maintained. _yes

na

Requirement: Records of outsourced activities shall be maintained. _na

5.13 Purchasing Information

yes

Requirement: Requirements for approval of supplier's procedures, processes, equipment, product and services and their release. _yes

yes

Requirement: Verification or validation activities that the organization, or its customer, intends to perform at the external providers' premises.

na Requirement: Control and monitoring of the external providers' performance to be applied by the organization.

ob ISO/API

8.4.2/5.6.1.2

Requirement: The Initial Supplier Evaluation - Noncritical Purchases shall include: Identifying how the supplied product conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements?

ISO/API 8.4.2/5.6.1.2

Requirement: The Initial Supplier Evaluation - Noncritical Purchases shall include: Assessment of the supplier to meet the organization's purchasing requirements?

ISO/API 8.4.2/5.6.1.2

Requirement: The Initial Supplier Evaluation - Noncritical Purchases shall include: Assessment of the product upon delivery or activity upon completion?

ISO/API 8.4.2/5.6.1.2

Requirement: The Initial Supplier Evaluation - Noncritical Purchases shall include: Identifying how the supplied product conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements?

ISO/API 8.4.2/5.6.1.2 ISO/API 8.4.2/5.6.1.2 ISO/API 8.4.2/5.6.1.2 ISO/API 8.4.2/5.6.1.2

Requirement: When an activity has been outsourced, the facility shall ensure that all applicable elements of the quality management system are satisfied and maintain responsibility for product conformance to specified requirements, including API.

ISO/API 8.4.2/5.6.1.2

ISO/API 8.4.3/5.6.2

Requirement: The organization shall ensure the adequacy of specified purchasing information prior to communication to the supplier. Purchasing information provided to the supplier shall be documented and adequately describe the product or activity to be purchased, including acceptance criteria and where appropriate.

ISO/API 8.4.3/5.6.2 ISO/API 8.4.3/5.6.2

Requirement: Purchasing information shall include an applicable version of the specification, drawing, process requirements, inspection instructions, traceability, procedure(s), and other relevant technical data, etc.

ISO/API 8.4.3/5.6.2

Requirement: Information describing the product to be purchased shall include where appropriate: Requirements for qualification of supplier's personnel, where appropriate.

ISO/API 8.4.3/5.6.2 ISO/API 8.4.3/5.6.2

(27)

Product & Service Realization

TARGET DATE CORRECTEDDATE 5.14 Verification of Purchased Product Doc. #

**Requirement: Control features shall be established for verification of purchased product.

yes yes

yes

Requirement: Evidence shall be provided to ensure purchased products and activities conform to specified requirements.

yes

Requirement: Records of verification activities shall be maintained.

yes

5.15 Production and Service Provision Doc. #

*Requirement: The organization shall maintain a documented procedure that describes controls associated with the production of product.

na na

na na Requirement: Product realization capability documentation shall include evidence of review and verification.

na Requirement: Product realization capability documentation shall include evidence of validation.

na Requirement: Product realization capability documentation shall include evidence of monitoring and measurement.

na na Requirement: Production and service provisions shall be performed under controlled conditions.

na Requirement: Controlled conditions shall include, as applicable: The availability of information that describes the characteristics of the product. na Requirement: Controlled conditions shall include, as applicable: The availability of work instructions, when applicable.

na Requirement: Controlled conditions shall include, as applicable: The implementation of the product quality plan, when applicable.

na Requirement: Controlled conditions shall include, as applicable: The availability and use of testing, monitoring, and measuring equipment.

na Requirement: Controlled conditions shall include, as applicable: The implementation of monitoring and measurement activities.

na na na Requirement: The organization maintain a documented procedure that describes controls associated with its servicing of products. _na

na ISO/API

8.6/5.6.3 ISO/API 8.6/5.6.3

Requirement: Inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements shall be implemented.

ISO/API 8.6/5.6.3

Requirement: Where it is intended to perform verification at the suppliers' premises, the intended verification arrangements and method of product release shall be stated in the purchasing information.

ISO/API 8.6/5.6.3 ISO/API 8.6/5.6.3 ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1

Requirement: Control features shall be established to control production and service activities including the implementation of actions to prevent human errors.

ISO/API 8.5.1/5.7.1.3

**Requirement: Process controls shall be documented in routings, travelers, checklists, processes sheets, etc. including the required inspection activities.

ISO/API 8.5.1/5.7.1.3

Requirement: The documented process controls shall include or reference instructions and acceptance criteria for processes, tests, inspections, and required customer's inspection hold and witness points.

Requirement: Product realization capability documentation shall include evidence of inspection and test activities including criteria for product acceptance. ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1

Requirement: Controlled conditions shall include, as applicable: The implementation of product release, including delivery and post-delivery activities.

ISO/API 8.5.1/5.7.1

Requirement: Controlled conditions shall include, as applicable: Ensuring design requirements and related changes are satisfied, where applicable

ISO/API 8.5.5/5.7.1.2

Requirement: The procedure shall address: Review and implementation of the organization's, customer-specific, product servicing, and other servicing requirements.

(28)

Product & Service Realization

na Requirement: The procedure shall address: The availability and use of suitable servicing, testing, monitoring, and measurement equipment.

na Requirement: The procedure shall address: The availability of work instructions, when applicable

na na Requirement: The procedure shall address: The implementation of monitoring and measurement activities

na Requirement: The procedure shall address: Process control documents

na Requirement: The procedure shall address: Requirements for release of the product that was serviced

na na na na na ISO/API 8.5.5/5.7.1.2 ISO/API 8.5.5/5.7.1.2 ISO/API 8.5.5/5.7.1.2 ISO/API 8.5.5/5.7.1.2

Requirement: The procedure shall address: Ensuring identification and traceability requirements are maintained throughout the servicing process ISO/API 8.5.5/5.7.1.2 ISO/API 8.5.5/5.7.1.2 ISO/API 8.5.5/5.7.1.2 ISO/API 8.5.5/5.7.1.2

Requirement: In determining the extent of post-delivery activities that are required, the org. shall consider statutory and regulatory requirements.

ISO/API 8.5.5/5.7.1.2

Requirement: In determining the extent of post-delivery activities that are required, the org. shall consider the potential undesired consequences associated with its product and services.

ISO/API 8.5.5/5.7.1.2

Requirement: In determining the extent of post-delivery activities that are required, the org. shall consider the nature, use and intended lifetime of its products and services

ISO/API 8.5.5/5.7.1.2

Requirement: In determining the extent of post-delivery activities that are required, the org. shall consider customer requirements and customer feedback.

(29)

Product & Service Realization

TARGET DATE CORRECTEDDATE 5.16 Validation of Processes for Production and Servicing

na na

na Requirement: Validation shall demonstrate the ability of these processes to achieve planned results and identification of acceptance criteria. na Requirement: Arrangements for these processes shall include, as applicable: Defined criteria for review and approval of the processes.

na Requirement: Do arrangements for these processes include, as applicable: Approval of equipment and qualification of personnel.

na na Requirement: Arrangements for these processes shall include, as applicable: Requirements for records.

na Requirement: Arrangements for these processes shall include, as applicable: Revalidation.

na 5.17 Product Quality Plans

na Requirement: The product quality plan by contract shall address: Description of the product to be manufactured.

na na Requirement: The product quality plan by contract shall address: Identification and reference to control of outsourced activities. _na na

na Requirement: Revisions to product quality plans shall be documented and approved to ensure customer requirements are met. _na 5.18 Identification and Traceability Doc. #

na **Requirement: Control features shall be established for controlling the use of the API Monogram in accordance with the applicable standard. na Requirement: Where appropriate, the product shall be identified by suitable means throughout product realization, including delivery and post de

na Requirement: The product status shall be identified with respect to monitoring and measurement requirements.

na Requirement: Controls shall be developed and in place to ensure maintenance or replacement of identification and/or traceability marks.

na Requirement: Where traceability is a requirement, the unique identification of the product shall be controlled and recorded.

na ISO/API

7.5.2/5.7.1.5

**Requirement: Control features shall be established for the qualification and validation of special processes (NDE, Welding, Heat Treat, etc.) for production/service provisions.

ISO/API 7.5.2/5.7.1.5

Requirement: Processes shall be validated for production and service provisions where the resulting output cannot be verified by subsequent monitoring or measurement.

ISO/API 7.5.2/5.7.1.5

Requirement: Processes shall be validated that includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Requirement: Arrangements for these processes shall include, as applicable: Use of specific methods, including identified operating parameters; identification of acceptance criteria

ISO/API 7.5.2/5.7.1.5 ISO/API 7.5.2/5.7.1.5 API 5.7.2

Requirement: Product quality plans shall be developed and include the processes of the quality management system and the resources to be applied to a product.

API 5.7.2

Requirement: The product quality plan by contract shall address: Required processes and documentation, including, required inspections, tests, and records, for conformance with requirements.

API 5.7.2

Requirement: The product quality plan by contract shall address: Identification of each procedure, specification, or other documented referenced or used in each activity.

API 5.7.2

Requirement: The product quality plan by contract shall address: Identification of the required hold, witness, monitor, and document review points.

API 5.7.2 ISO/API 8.5.2/5.7.3

**Requirement: Control features shall be established for product identification and traceability which include production status identification maintenance. ISO/API 8.5.2/5.7.3 ISO/API 8.5.2/5.7.3 ISO/API 8.5.2/5.7.3 ISO/API 8.5.2/5.7.3 ISO/API 8.5.2/5.7.3

(30)

Product & Service Realization

TARGET DATE CORRECTEDDATE 5.19 Customer Property - External Providers Doc. #

**Requirement: Control features shall be established for control of property belonging to customers or external providers.

na Requirement: Care shall be taken with customer property while it is under control or being used.

na na na Requirement: Records of control and disposition of customer-supplied property shall be maintained.

na ISO/API 8.5.3/5.7.5 ISO/API 8.5.3/5.7.5 ISO/API 8.5.3/5.7.5

Requirement: Customer property provided for use or incorporation into the product shall be identified, verified, protected, safeguarded, preserved, and maintained (pm maintenance).

ISO/API 8.5.3/5.7.5

Requirement: If any customer property is lost, damaged or otherwise found to be unsuitable for use, shall be reported to the customer and records shall be maintained.

ISO/API 8.5.3/5.7.5