ISO 9001_2015 API Q1 Audit Checklist Template
Short Description
ISO 9001_2015 API Q1 Audit Checklist Template...
Description
Audit Checklist
Conforms to ISO 9001:2015 and API Q1 9th Addition
1 1a 1b 1c 1d 1e 2 2a 2b 2c 3 3a 3b
Point / Percentage Scoring 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 in the score there will not be any negative percentage, any negative will = 0% Note that ob, mi and ma are tallied in the total score divide by the activities for the result % Compliant Score Banding 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 replanning along with strong targets and initiatives to get this into the green. Audit Fill Sheet General activity criteria questions Make comments of issues and non-evidence found under the criteria questions, this is pre-formatted in blue.
3f
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.
3g
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.
3c 3d 3e
3h 3i 3j 3k 4 4a 4b 4c 4d 5 5a
5b
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. Rollup Details & Chart Would be the overall view of the results from all audit sheets and chart information Activities would be the quantity of criteria questions in the respective element Corrections quantity is the sum of minors and major findings count. All Minor and Major findings would require a formal CAR to be action for resolution and root cause identification Other Time required to submit proposed corrective actions will follow the dates set. Observations (ob) - Not required but advised Minor (mi) - 14 days Major (ma) - 14 to 30-days 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
Guidelines
Guidelines
Business Unit - Full Audit System Checklist Observations
No.
Audit Area
Minor
Major
% Complaint
Activities
Before Correction
After Correction
Before Correction
After Correction
Before Correction
After Correction
Audit Score
Correction Score
1 2 3 4 5
Quality Management System Management Responsibility Risk Management Resource Management Product & Service Realization
19 57 0 15 104
3 16 0 7 26
16 39 18 18 168
3 2 0 0 2
15 51 18 25 192
0 0 0 1 0
18 53 18 24 194
44.7% 75.4% NA 10.0% 81.7%
2219.0% 5017.9% NA 2400.0% 13684.2%
6
Measurement, Analysis and Improvement
67
17
61
7
68
0
75
56.0%
3337.3%
Totals
262
69
320
14
369
1
382
67.0%
5880.9%
Scoring
% Compliant (Audit Score)
86 - 100%
16000.0%
71 - 85%
14000.0%
0 - 70%
% Compliant (Correction Score)
Total Audit Score
Total Correction Score
13684%
12000.0% 10000.0% 8000.0% 6000.0%
5018%
4000.0%
3337% 2400%
2219%
2000.0% 0.0%
45%
Quality Management System
75%
Management Responsibility
10%
Risk Management
Resource Management
82%
Product & Service Realization
56%
Measurement, Analysis and Improvement
Opportunity for Improvement
OFI#
DATE
LOCATION
FROM
CATEGORY
Total OFI Value Improvement [$]
$0
Total No. of OFI Submissions
0
DETAILS
POSSIBLE ROOT CAUSES
POSSIBLE SOLUTIONS
PONC IMPROVEMENT [$]
COMMENTS
SUPERVISOR ACTION
RESPONSIBLE PARTY
CORRECTION TARGET DATE
CORRECTED DATE
General Observation
GOB#
DATE
LOCATION
FROM
CATEGORY
Total No. of General Observation(s)
0
DETAILS
CORRECTIVE ACTION (TAKEN OR SUGGESTED)
RESPONSIBLE PARTY
CORRECTION TARGET DATE
CORRECTED DATE
PHOTO
Quality Management System 1.1 API 4.2.1 ISO/API 5.2.1 & 6.2/4.1.3 ISO/API 4.1 ISO 4.2 ISO/API 4.4.1/4.3.1 ISO/API 7.4/4.1.5 ISO/API 7.5.1/4.5 1.2
General QMS Requirements- Does the quality management system include: *Requirement: The organization shall establish a documented and implemented QMS.
COMPLY LEVEL
MI
*Requirement: The QMS shall include documented evidence of statements of the quality policy and applicable objectives. yes *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)
yes
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.
ob
*Requirement: The QMS shall include evidence of provisions for continual improvement. *Requirement: The QMS shall include provisions to communicate performance measures to everyone in the organization. Requirement: The QMS shall include quality records required by the standards.
yes yes yes
ISO/API 4.2/4.4.1
Quality Manual - Does the quality manual include: Obtain copy or review Doc. # **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)
yes
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.
mi
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Quality Management System 1.3 ISO/API 7.5.2/4.4.3 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 1.4 ISO/API 7.5.3/4.5
Control of Documents - (Documented Information) Is there a documented procedure requiring that: Review Doc. # Requirement: The Control of Documents Procedure shall address changes to documents to be reviewed and approved prior to issue and use. Requirement: The Control of Documents Procedure shall address how documents are reviewed, updated, and re-approved. Requirement: The Control of Documents Procedure shall address the status of changes and revisions. Requirement: The Control of Documents Procedure shall address relevant versions are available where the activity is being pe Requirement: The Control of Documents Procedure shall address how documents are to be legible and readily identifiable. Requirement: The Control of Documents Procedure shall address how external documents are identified, and their distribution i Requirement: The Control of Documents Procedure shall address how obsolete documents are not used by mistake and are ident Control of Quality Records (Retained documented information) Doc # Retention List Doc # 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
Requirement: The Control of Records Procedure shall address how quality records are to be legible and retrievable.
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.
COMPLY LEVEL
ob yes mi ob yes yes yes
yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Business Unit - Full Audit System Observations 1 1.1 1.2 1.3 1.4
Quality Management System
Major
% Compliant
Before Correction
After Correction
Before Correction
After Correction
Before Correction
After Correction
Audit Score
Correction Score
7 2 7 3 19
1 0 2 0 3
6 2 5 3 16
1 1 1 0 3
5 1 6 3 15
0 0 0 0 0
6 2 7 3 18
50.0% 0.0% 42.9% 100.0% 44.7%
2228.6% 800.0% 2262.5% #DIV/0! 2219.0%
General Quality Manual Control of Documents Control of Quality Records Totals
Scoring 86 - 100%
Minor
Activities
% Compliant (Audit Score)
% Compliant (Correction Score)
Total Audit Score
Total Correction Score
2500.0% 2263%
2229%
2219%
71 - 85% 2000.0%
0 - 70%
1500.0%
1000.0% 800%
500.0%
50%
43%
0.0% General
0%
Quality Manual
Control of Documents
100%
45% Control of Quality Records
Management Responsibility 2.1 ISO/API 5.1/4.2 ISO/API 5.1/4.2
Management / Leadership commitment - Top management shall demonstrate leadership and commitment with respect to the QMS by: Requirement: Taking accountability for the effectiveness of the QMS 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.
COMPLY LEVEL yes yes
*Requirement: Ensuring the integration of the QMS into the organization's business processes. ISO/API 5.1/4.2
yes *Requirement: Promoting the use of the process approach and risk-based thinking.
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
ob Requirement: Ensuring the resources needed for the effective implementation of the QMS are available. Requirement: Communicating the importance of effective quality management and of conforming to the QMS requirements. Requirement: Ensuring the QMS achieves its intended results. (Also see Management Review) Requirement: Engaging, directing and supporting persons to contribute to the effectiveness of the QMS. Requirement: Promote improvement. Requirement: Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. 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: 2.2 *Requirement: Customer and applicable statutory and regulatory requirements are determined, understood and consistently met. 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 ISO/API satisfaction are determined and addressed. 5.1.2/4.1.5 ISO/API 5.1.2/4.1.5 2.3 ISO/API 5.2/4.1.2 ISO/API 5.2/4.1.2 ISO/API 5.2/4.1.2 ISO/API 5.2/4.1.2 ISO/API 5.2/4.1.2 ISO/API 5.2/4.1.2 2.4
Requirement: The focus on enhancing customer satisfaction is maintained. Quality Policy - Top management shall establish, implement and maintain a quality policy that: **Requirement: Top management shall approve a documented Quality Policy. Requirement: Is appropriate to the purpose and context of the organization and supports its strategic direction. Requirement: The Quality Policy shall include a commitment to comply with requirements and will continue to improve the effectiveness of the QMS. Requirement: The Quality Policy shall include a framework for establishing and reviewing quality objectives. 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. Requirement: The Quality Policy shall be reviewed for continuing suitability. (See Management Review) Quality Objectives - The organization shall:
mi yes yes yes ob yes yes
yes ob yes
yes yes yes yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
ISO/API 6.2/4.1.3 ISO/API 6.2/4.1.3 ISO/API 6.2/4.1.3 2.5
Management Responsibility
COMPLY LEVEL
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.
yes
Requirement: Quality objectives shall be measurable and consistent with the quality policy. Requirement: Quality objectives shall be measurable; be measurable; be communicated; be updated, as appropriate and documented information (records) maintained.
ob
Quality management system planning -
Requirement: Does top management ensure that criteria and methods needed for the operation and control of all QMS processes are ISO/API determined, management and effective and planning of the QMS is carried out in order to meet the requirements of the standards? 5.4.2/4.1.4 ISO/API 6.1/5.11 ISO 6.3
yes
Requirement: When planning the QMS does top management take actions to address risk and opportunities? Requirement: When the organization determines the need for changes to the QMS, the changes shall be carried out in a planned manner.
yes ob yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Management Responsibility 2.6 ISO/API 5.5.2/4.2.3
Management representative/Organizational roles, responsibilities and authorities Requirement: Top management shall appoint a member of management who, irrespective of other responsibilities, will have responsibility and authority.
COMPLY LEVEL
yes
Requirement: The appointed member of management shall ensure processes needed for the QMS are established, implemented, ISO/API maintained and conforms to the requirements of the applicable standards. 5.5.2/4.2.3
yes
Requirement: The appointed member of management shall reports to top management on the performance and needed improvements of the ISO/API QMS. 5.5.2/4.2.3
yes
Requirement: The appointed member of management shall ensure customer requirements are made aware and are promoted throughout the ISO/API organization. 5.5.2/4.2.3
yes
Requirement: The appointed member of management shall ensure that the integrity of the QMS is maintained when changes to the QMS are ISO/API planned and implemented. 5.5.2/4.2.3
ob
2.7 ISO/API 7.4/4.1.5 ISO/API 7.4/4.1.5 2.8 ISO/API 9.3/6.5 API 6.5 API 6.5 ISO/API 9.3/6.5 2.9 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
Internal / External communication 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.
yes
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.
yes
Management review Doc # Requirement: Top management shall review the QMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. ** Top management must conduct an annual management review. Requirement: The management review shall include assessment of opportunities for improvement and needed changes to the QMS including the policy and objectives. Requirement: Records from management reviews shall be maintained. Review Input - Does the input to management review include: Doc. # Requirement: Effectiveness and status of actions taken from previous management review. Requirement: Changes in external and internal issues that are relevant to the QMS Requirement: Status of corrective and preventive actions Requirement: Changes that could affect the QMS, including changes to legal and other applicable requirements (e.g. industry standards) Requirement: Analysis of customer satisfaction and feedback from relevant interested parties Requirement: The extent to which quality objectives have been met Requirement: Analysis of supplier performance Requirement: Review and analysis of product conformity, including nonconformances identified after delivery and use Requirement: Results of audits Requirement: Process performance
mi yes ob yes
yes ob ob ob yes yes yes yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Management Responsibility ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 ISO/API 9.3/6.5.2 2.10 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
Requirement: Inputs to the management review shall include results of risk assessments. Requirement: The adequacy of resources Requirement: Opportunities and recommendations for improvement. Review output - Does the output from the management review include any decisions and actions related to: Requirement: Assessment of the effectiveness of the QMS and any needed or required changes including decisions and required actions Requirement: Improvement made to products and to customer requirements. Requirement: Needed resources. Requirement: Opportunity for improvement. Requirement: Approved by top management and documented information retained.
COMPLY LEVEL ob ob ob
ob ob yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Business Unit - Full Audit System Observations Minor 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10
Management Responsibility Management Commitment Customer Focus Quality Policy Quality Objectives QM System Planning Management Representative Internal Communication Management Review Review Input Review Output Totals
Scoring 86 - 100% 71 - 85%
120.0%
% Compliant
Before Correction
After Correction
Before Correction
After Correction
Before Correction
After Correction
Audit Score
Correction Score
11 2 6 3 3 5 5 4 13 5 57
2 1 0 1 1 1 1 1 6 2 16
9 1 6 2 2 4 2 3 7 3 39
1 0 0 0 0 0 0 1 0 0 2
0 2 6 3 3 5 2 3 13 5 42
0 0 0 0 0 0 0 0 0 0 0
10 2 6 3 3 5 2 4 13 5 53
63.6% 75.0% 100.0% 83.3% 83.3% 90.0% 90.0% 12.5% 76.9% 80.0% 75.4%
2612.5% 5300.0% #DIV/0! 8000.0% 8000.0% 13400.0% 5400.0% 1442.9% 5750.0% 6650.0% 4825.0%
% Complaint (Audit Score)
2613%
Major
Activities
5300%
% Complaint (Correction Score)
8000%
8000%
Total Audit Score
13400%
5400%
Total Correction Score
1443%
5750%
100%
100.0%
4825% 90%
0 - 70%
83%
80.0%
6650%
90%
83% 77%
75%
80%
64%
60.0% 40.0% 20.0% 0.0%
13%
75%
Risk Management 3.1
COMPLY LEVEL
Risk Identification *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.
ISO/API 6.1/5.3 How is this being done? Evidence: Finding: Requirement: Risk assessment associated with product delivery shall include facility/equipment availability and maintenance. ISO/API 6.1/5.3 Evidence: Finding: Requirement: Risk assessment associated with product delivery shall include supplier performance and material availability/supply. ISO/API 6.1/5.3 Evidence: Finding: Requirement: Risk assessment associated with product quality shall include, as applicable: Delivery of nonconforming product. ISO/API 6.1/5.3 Evidence: Finding: Requirement: Risk assessment associated with product quality shall include, as applicable: Availability of competent personnel. ISO/API 6.1/5.3 Evidence: Finding: Requirement: What type of records are maintained as a result of assessment and management of the product and processes including ISO/API actions taken? 6.1/5.3 Evidence: Finding: Contingency Planning 3.2 Requirement: A Contingency Planning Procedure shall be implemented to address the risk associated with the impact on delivery and quality ISO/API of the product. 6.1.2/5.5 Evidence: Finding: Requirement: The Contingency Planning Procedure shall address actions required in response to significant risk scenarios to mitigate effects ISO/API of disruptive incidents. 6.1.2/5.5. Evidence: 2 Finding: Requirement: The Contingency Planning Procedure shall address identification and assignment of responsibilities and authorities. ISO/API Evidence: 6.1.25.5.2 Finding: ISO/API Requirement: The Contingency Planning Procedure shall address: Internal and External communication controls. 6.1.2/5.5. Evidence: Finding: 2 ISO/API Requirement: The Contingency Planning Procedure shall address: How outputs are documented, communicated and addressed. 6.1.2/5.5. Evidence: Finding: 2 Management of Change 3.3 Requirement: A Management of Change process shall be established by the organization. ISO/API Verify knowledge and understanding of the requirement 6.1.2/5.11 Evidence: (8.5.6) Finding: Requirement: The MOC process shall address processes that may negatively impact the quality of the product and changes in the organizational structure. ISO/API 6.1.2/5.11 Verify in-process or completed MOCs for organizational structure. Evidence: Finding: Requirement: The MOC process shall address processes that may negative impact the quality of the product and changes in key or essential personnel. ISO/API 6.1.2/5.11
na
na
na
na
na
na
na
na
na
na
na
na
na
na
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Risk Management ISO/API 6.1.2/5.11 Verify in-process or completed MOCs for changes in key or essential personnel. Evidence: Finding: Requirement: The MOC process shall address processes that may negative impact the quality of the product and changes in critical suppliers. ISO/API 6.1.2/5.11 Verify in-process or completed MOCs for changes in critical suppliers. Evidence: Finding: 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. ISO/API 6.1.2/5.11 Verify in-process or completed MOCs for changes in the management system. Evidence: Finding: MOC Notification 3.4 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. API Verify the relevant personnel were notified of changes. 5.11 Evidence: Finding: Requirement: Records of MOCs shall be maintained and stored. ISO/API Review MOCs and verify storage location. 8.5.6/5.11 Evidence: Finding:
COMPLY LEVEL na
na
na
na
na
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Business Unit - Full Audit System Observations Minor 3 3.1 3.2 3.3 3.4
Risk Management
After Correction
Before Correction
After Correction
Before Correction
After Correction
Audit Score
Correction Score
0 0 0 0 0
0 0 0 0 0
6 5 5 2 18
0 0 0 0 0
6 5 5 2 18
0 0 0 0 0
6 5 5 2 18
NA NA NA NA NA
NA NA NA NA NA
Totals
86 - 100% 71 - 85%
% Compliant
Before Correction
Risk Identification Hazard Control Management of Change Achievement of Objectives
Scoring
Major
Activities
% Compliant (Audit Score)
% Compliant (Correction Score)
Total Audit Score
Total Correction Score
1200.0%
1000.0%
0 - 70% 800.0%
600.0%
400.0%
200.0%
0.0% Risk Identification
Hazard Control
Management of Change
Achievement of Objectives
Resource Management Provision of resources - Organizational Knowledge ### *Requirement: The organization shall determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the QMS. ### *Requirement: The organization shall consider the capabilities of, and constraints on, existing internal resources ISO/API 6.14.1/4.3.1 ### Requirement: The organization shall consider what needs to be obtained from external providers. ISO/API 6.14.1/4.3.1 ### Requirement: The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of ISO products and services. This Knowledge shall be maintained and be made available to the extent necessary. 7.1.6 ### Requirement: When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to ISO acquire or access any necessary additional knowledge and required updates. 7.1.6 ### ### Human Resources - General 4.2 *Requirement: Job responsibilities shall be developed and verified with each employee. API ### 4.3.2 Requirement: The organization shall determine and provide the persons necessary for the effective implementation of its QMS and for the ISO operation and control of its processes. 7.1.2 ### ### Competence, Awareness and Training 4.3 *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 ISO/API experience needed to meet product and customer requirements. Evidence of the determination of competence of personnel shall be 7.2/4.3.2.3 recorded and maintained. ### **Requirement: Training needs and the frequency of training shall be identified and provided including IMS and specific job skills. ISO/API 6.2.2/4.3.2.3 ### Requirement: Training or other actions shall be provided to satisfy the needs of the QMS. ISO/API 7.2/4.3.2.3 ### Requirement: The effectiveness of training shall be evaluated. ISO/API 7.2/4.3.2.3 ### Requirement: Personnel shall be made aware of the quality policy and relevant quality objectives. 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 ISO/API achievement of the quality objective and the implications of not conforming with the QMS. 7.3/4.3.2.3 ### Requirement: Appropriate records shall be maintained of education, training, skills and experience for all employees. ISO/API 7.2/4.3.2.3 ### ### Environment for the operation of processes 4.4 Requirement: The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to ISO achieve conformity of product and services. 7.1.3 ### ### Work environment - Infrastructure 4.5 Requirement: The work environment shall be managed to achieve conformity to product requirements. ISO/API 7.1.4/4.3.3 ###
COMPLY LEVEL
4.1
ISO/API 7.1/4.3.1
yes yes yes yes
yes
yes ob
ma
ob ob ob ob ob ob
yes
na
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Business Unit - Full Audit System Observations Minor 4 4.1 4.2 4.3 4.4 4.5 4.6
Resource Management Provision of Resources Human Resources - General Competence, Awareness and Training Environment Work Environment Preventive Maintenance Totals
Scoring 86 - 100%
Major
% Compliant
Activities
Before Correction
After Correction
Before Correction
After Correction
Before Correction
After Correction
Audit Score
Correction Score
5 2 7 1 0 0 15
0 1 6 0 0 0 7
5 1 1 1 5 5 18
0 0 0 0 0 0 0
5 2 7 1 5 5 25
0 0 1 0 0 0 1
5 2 6 1 5 5 24
100.0% 75.0% 0.0% 100.0% NA NA 10.0%
#DIV/0! 5300.0% 626.9% #DIV/0! NA NA 2400.0%
% Complaint (Audit Score)
% Complaint (Correction Score)
Total Audit Score
Total Correction Score
6000.0% 5300%
71 - 85%
2400%
5000.0%
0 - 70% 4000.0%
3000.0%
2000.0%
1000.0%
627% 100%
Provision of Resources
100%
75%
0.0% Human Resources General
0% Competence, Awareness and Training
10% Environment
Work Environment
Preventive Maintenance
Product & Service Realization 5.1 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 ISO/API 8.1/5.2 ISO/API 8.1/5.2 ISO/API 8.1/5.2 ISO/API 8.1/5.2 5.2 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 5.3 ISO/API 8.2.3/5.1.3 ISO/API 8.2.3/5.1.3 ISO/API 8.2.3/5.1.3 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 ISO/API 8.2.3/5.1.3 ISO/API 8.2.4/5.1.3
COMPLY LEVEL
Planning of Product Realization Doc. # Requirement: A process shall be developed and in place for product realization consistent with the requirement of the other processes of the QMS.
yes
Requirement: Planning shall be conducted and documented by the organization to address required resources and work environment management.
yes
Requirement: Planning shall be conducted and documented by the organization to address product and customer-specified requirements. Requirement: Planning by the organization shall address: Legal and other applicable requirements. Requirement: Planning by the organization shall address: Contingencies based on risk assessment. Requirement: Planning by the organization shall address: Design and Development. 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. Requirement: Planning by the organization shall address: Management of Change. 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: Requirement: Requirements specified by the customer. Requirement: Legal and other applicable requirements. Requirement: Requirements not stated by the customer but considered necessary by the organization for the provision of the product Requirement: Where the customer provides no documented statement of the requirement, the customer requirements shall be confirmed by the organization and records maintained. Review of requirements related to the product *Requirement: A standardized contract review process shall be developed and implemented. 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… Requirement: Requirements specified by the customer are identified and documented including delivery and post delivery activity. Requirement: Requirements differing from those previously identified are resolved Requirement: The organization has the capability to met the documented requirements. 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. Requirement: Records of the results of the review, including resulting actions, shall be maintained. Requirement: Statutory and regulatory requirements applicable to the product and services 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.
yes yes ob yes yes yes yes
yes yes yes yes
yes yes yes yes yes yes yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Product & Service Realization 5.4 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 ISO/API 8.2.1/4.1.5.2 ISO/API 8.2.1/4.1.5.2 5.5
Customer Communication *Requirement: A process shall be developed and implemented for communicating NOV facility's successes to our customers. Requirement: Effective arrangements for communicating with customers shall be made in relation to product information.
Requirement: Effective arrangements for communicating with customers shall be made in relation to Customer feedback, including customer complaints.
yes
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.
Requirement: The requirements for a final review of the design shall be determined.
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 ISO/API 8.3.2/5.4.1 ISO/API 8.3.2/5.4.1 5.6 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
yes
Design and development planning
ISO/API 8.3.2/5.4.1 ISO/API 8.3.2/5.4.1
ISO/API 8.3.2/5.4.1
yes yes
Requirement: The organization shall maintain a documented procedure to plan and control the design and development of the product.
ISO/API 8.3.2/5.4.1
yes
Requirement: Effective arrangements for communicating with customers shall be made in relation to inquiries, contracts or order handling, including amendments.
ISO/API 8.3.2/5.4.1
ISO/API 8.3.2/5.4.1
COMPLY LEVEL
Requirement: The procedure shall identify the plan(s), including plan updates, used for design development.
yes yes yes
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.
yes
Requirement: The procedure shall identify the internal and external resources, responsibilities, authorities, and their interfaces to ensue effective communication.
yes
Requirement: The procedure shall identify the review, verification, and validation activities necessary to complete each design and development stage
yes
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.
yes
Requirement: The procedure shall identify the final review of the design Requirement: The level of control expected for the design and development process by customers and relevant interested parties.
yes yes
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.
na
Requirement: When design and development are outsourced, the organization shall ensure the supplier meets the requirements outlined in purchasing.
yes
Requirement: The documented information (records) needed to demonstrate that design and development requirements have been met. Design and development inputs - Are there records of inputs relating to product requirements that include: **Requirement: Product design inputs shall be identified, documented reviewed for adequacy and lack of conflict. **Requirement: Product design inputs shall include customer specified requirements. Requirement: Product design input requirements shall be provided from external sources, including API product specifications. Requirement: Applicable legal, statutory and regulatory product input requirements shall be determined and documented. Requirement: Historical performance inputs where applicable, information derived from previous similar designs shall be determined and documented.
yes
yes yes yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
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
Product & Service Realization Requirement: Other inputs and requirements essential for design and development of the product shall be determined and documented. 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. Requirement: Results from risk assessments (See risk section) Requirement: Records of product design inputs shall be maintained.
COMPLY LEVEL yes yes
yes
ob yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Product & Service Realization 5.7 ISO/API 8.3.5/5.4.3
Design and development outputs 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
Requirement: Provide appropriate information for purchasing production and servicing.
ISO/API 8.3.5/5.4.3
Requirement: Include results of applicable calculations
ISO/API 8.3.5/5.4.3 ISO/API 8.3.5/5.4.3 5.8 ISO/API 8.3.4/5.4.4
Requirement: Specify the characteristics of the product that are essential for its safe and proper use.
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 8.3.4/5.4.4 5.9 ISO/API 8.3.4/5.4.5 ISO/API 8.3.4/5.4.5 5.10 ISO/API 8.3.4/5.4.6 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
Requirement: Identify or reference design acceptance criteria (DAC) Requirement: Include identification of, or reference to, products and/or components deemed critical to the design
Requirement: Records of the design outputs shall be maintained. Design and Development Review **Requirement: The final design review shall be conducted, documented and approved by someone who did not develop the design. Requirement: Systematic reviews shall be conducted and shall evaluate the ability of the design and development activity to fulfill requirements. Requirement: The systematic review shall identify any problems and propose necessary actions. Requirement: Representatives of functions concerned with the design and development stage review shall be included. Requirement: Records of the results of the reviews and any necessary actions shall be maintained. Design and Development Verification Requirement: Verification shall be performed to ensure design and development outputs satisfy the design and development input requirements Requirement: Records of the results of the verification and any necessary actions shall be maintained. Design and Development Validation and Approval 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. Requirement: Validation shall be completed prior to the delivery or implementation of the product when possible. Requirement: Records of the results of validation and any necessary actions shall be maintained. Requirement: The completed design shall be approved after validation. Requirement: Final approval of the design shall be completed by competent individual(s) independent of the person(s) who developed the desi Requirement: Records of design and development validation, approval, and necessary actions shall be maintained.
COMPLY LEVEL
yes yes yes yes yes yes yes
mi ob ob ob ob
yes yes
yes yes yes yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Product & Service Realization 5.11 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 ISO/API 8.3.6/5.4.7 5.12 ISO/API 8.4.1/5.6.1 ISO/API 8.4.1/5.6.1 ISO/API 8.4.1/5.6.1 ISO/API 8.4.1/5.6.1 ISO/API 8.4.1/5.6.1.1 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 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 8.4.2/5.6.1.2 ISO/API 8.4.2/5.6.1.2 ISO/API 8.4.2/5.6.1.2
Design and Development Changes **Requirement: Design and development changes shall have the same controls as the original design. Requirement: Design and development changes shall be identified, authorized and records shall be maintained. Requirement: Changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. 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. Requirement: Records of the results of the review of changes and any necessary actions shall be maintained. Purchasing - Control of externally provided resources, product and services Requirement: A process shall be developed and implemented to ensure purchased product or outsourced activities conform to specific requirements for procured goods and services. Requirement: Purchased products shall conform to specified requirements. 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. Requirement: The determination of criticality of activities or products as applicable to conformance of product or customer specifications. Requirement: The initial evaluation and selection of suppliers based on their ability to supply products or activities in accordance with the organization's requirements.
COMPLY LEVEL
yes yes yes yes yes
ob na
mi
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
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.
ob
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.
ob
Requirement: The Initial Supplier Evaluation - Critical Purchases shall include the assessment of the supplier to ensure the capability to meet the desired purchasing requirements.
ob
Requirement: The Initial Supplier Evaluation - Critical Purchases shall include: Assessment of the supplier by performing an on-site evaluation of relevant activities.
ob
Requirement: The Initial Supplier Evaluation - Critical Purchases shall include: Assessment of the supplier by performing first article inspection to ensure conformance to stated requirements.
ob
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?
ob
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?
ob
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Product & Service Realization 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 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 ISO/API 8.4.2/5.6.1.2 5.13 ISO/API 8.4.3/5.6.2 ISO/API 8.4.3/5.6.2 ISO/API 8.4.3/5.6.2 ISO/API 8.4.3/5.6.2 ISO/API 8.4.3/5.6.2 ISO/API 8.4.3/5.6.2
COMPLY LEVEL
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?
ob
Requirement: The Initial Supplier Evaluation - Noncritical Purchases shall include: Assessment of the supplier to meet the organization's purchasing requirements?
ob
Requirement: The Initial Supplier Evaluation - Noncritical Purchases shall include: Assessment of the product upon delivery or activity upon completion?
ob
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?
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. 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. Requirement: Records of outsourced activities shall be maintained. Purchasing Information 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. Requirement: Requirements for approval of supplier's procedures, processes, equipment, product and services and their release.
yes na na
yes
yes
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.
yes
Requirement: Information describing the product to be purchased shall include where appropriate: Requirements for qualification of supplier's personnel, where appropriate.
yes
Requirement: Verification or validation activities that the organization, or its customer, intends to perform at the external providers' premises. Requirement: Control and monitoring of the external providers' performance to be applied by the organization.
na ob
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Product & Service Realization 5.14 ISO/API 8.6/5.6.3 ISO/API 8.6/5.6.3 ISO/API 8.6/5.6.3 ISO/API 8.6/5.6.3 ISO/API 8.6/5.6.3 5.15 ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1 ISO/API 8.5.1/5.7.1.3 ISO/API 8.5.1/5.7.1.3 ISO/API 8.5.1/5.7.1.4 ISO/API 8.5.1/5.7.1.4 ISO/API 8.5.1/5.7.1.4 ISO/API 8.5.1/5.7.1.4
Verification of Purchased Product Doc. # **Requirement: Control features shall be established for verification of purchased product.
yes
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.
yes
Requirement: Evidence shall be provided to ensure purchased products and activities conform to specified requirements. Requirement: Records of verification activities shall be maintained. Production and Service Provision Doc. # *Requirement: The organization shall maintain a documented procedure that describes controls associated with the production of product.
na
**Requirement: Process controls shall be documented in routings, travelers, checklists, processes sheets, etc. including the required inspection activities.
na
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.
na
Requirement: Product realization capability documentation shall include evidence of review and verification. Requirement: Product realization capability documentation shall include evidence of validation. Requirement: Product realization capability documentation shall include evidence of monitoring and measurement. Requirement: Product realization capability documentation shall include evidence of inspection and test activities including criteria for product acceptance.
Requirement: Controlled conditions shall include, as applicable: The availability of information that describes the characteristics of the product.
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 availability of work instructions, when applicable.
ISO/API 8.5.5/5.7.1.2
yes
na
ISO/API 8.5.1/5.7.1
ISO/API 8.5.5/5.7.1.2
yes
Requirement: Control features shall be established to control production and service activities including the implementation of actions to prevent human errors.
Requirement: Production and service provisions shall be performed under controlled conditions.
ISO/API 8.5.1/5.7.1
yes
Requirement: Inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements shall be implemented.
ISO/API 8.5.1/5.7.1
ISO/API 8.5.1/5.7.1
COMPLY LEVEL
Requirement: Controlled conditions shall include, as applicable: The implementation of the product quality plan, when applicable. Requirement: Controlled conditions shall include, as applicable: The availability and use of testing, monitoring, and measuring equipment. Requirement: Controlled conditions shall include, as applicable: The implementation of monitoring and measurement activities.
na na na na na na na na na na
Requirement: Controlled conditions shall include, as applicable: The implementation of product release, including delivery and post-delivery activities.
na
Requirement: Controlled conditions shall include, as applicable: Ensuring design requirements and related changes are satisfied, where applicable
na
Requirement: The organization maintain a documented procedure that describes controls associated with its servicing of products.
na
Requirement: The procedure shall address: Review and implementation of the organization's, customer-specific, product servicing, and other servicing requirements.
na
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
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 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 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
Product & Service Realization Requirement: The procedure shall address: The availability and use of suitable servicing, testing, monitoring, and measurement equipment. Requirement: The procedure shall address: The availability of work instructions, when applicable Requirement: The procedure shall address: Ensuring identification and traceability requirements are maintained throughout the servicing process Requirement: The procedure shall address: The implementation of monitoring and measurement activities Requirement: The procedure shall address: Process control documents Requirement: The procedure shall address: Requirements for release of the product that was serviced
COMPLY LEVEL na na na na na na na
Requirement: In determining the extent of post-delivery activities that are required, the org. shall consider statutory and regulatory requirements.
na
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.
na
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
na
Requirement: In determining the extent of post-delivery activities that are required, the org. shall consider customer requirements and customer feedback.
na
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Product & Service Realization
COMPLY LEVEL
Validation of Processes for Production and Servicing **Requirement: Control features shall be established for the qualification and validation of special processes (NDE, Welding, Heat Treat, etc.) for production/service provisions.
na
Requirement: Processes shall be validated for production and service provisions where the resulting output cannot be verified by subsequent monitoring or measurement.
na
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.
na
ISO/API 7.5.2/5.7.1.5
Requirement: Validation shall demonstrate the ability of these processes to achieve planned results and identification of acceptance criteria.
na
ISO/API 7.5.2/5.7.1.5 ISO/API 7.5.2/5.7.1.5
Requirement: Arrangements for these processes shall include, as applicable: Defined criteria for review and approval of the processes.
5.16 ISO/API 7.5.2/5.7.1.5 ISO/API 7.5.2/5.7.1.5 ISO/API 7.5.2/5.7.1.5
ISO/API 7.5.2/5.7.1.5 ISO/API 7.5.2/5.7.1.5 ISO/API 7.5.2/5.7.1.5 5.17 API 5.7.2 API 5.7.2 API 5.7.2 API 5.7.2 API 5.7.2 API 5.7.2 API 5.7.2 5.18
Requirement: Do arrangements for these processes include, as applicable: Approval of equipment and qualification of personnel. Requirement: Arrangements for these processes shall include, as applicable: Use of specific methods, including identified operating parameters; identification of acceptance criteria Requirement: Arrangements for these processes shall include, as applicable: Requirements for records. Requirement: Arrangements for these processes shall include, as applicable: Revalidation. Product Quality Plans 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. Requirement: The product quality plan by contract shall address: Description of the product to be manufactured. Requirement: The product quality plan by contract shall address: Required processes and documentation, including, required inspections, tests, and records, for conformance with requirements. Requirement: The product quality plan by contract shall address: Identification and reference to control of outsourced activities.
na na na na na
na na na na
Requirement: The product quality plan by contract shall address: Identification of each procedure, specification, or other documented referenced or used in each activity.
na
Requirement: The product quality plan by contract shall address: Identification of the required hold, witness, monitor, and document review points.
na
Requirement: Revisions to product quality plans shall be documented and approved to ensure customer requirements are met.
na
Identification and Traceability Doc. # **Requirement: Control features shall be established for product identification and traceability which include production status identification maintenance.
na
ISO/API 8.5.2/5.7.3
**Requirement: Control features shall be established for controlling the use of the API Monogram in accordance with the applicable standard.
na
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
Requirement: Where appropriate, the product shall be identified by suitable means throughout product realization, including delivery and post de
ISO/API 8.5.2/5.7.3
Requirement: The product status shall be identified with respect to monitoring and measurement requirements. Requirement: Controls shall be developed and in place to ensure maintenance or replacement of identification and/or traceability marks. Requirement: Where traceability is a requirement, the unique identification of the product shall be controlled and recorded.
na na na na
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Product & Service Realization 5.19 ISO/API 8.5.3/5.7.5 ISO/API 8.5.3/5.7.5 ISO/API 8.5.3/5.7.5 ISO/API 8.5.3/5.7.5 ISO/API 8.5.3/5.7.5
Customer Property - External Providers Doc. # **Requirement: Control features shall be established for control of property belonging to customers or external providers. Requirement: Care shall be taken with customer property while it is under control or being used.
COMPLY LEVEL
na na
Requirement: Customer property provided for use or incorporation into the product shall be identified, verified, protected, safeguarded, preserved, and maintained (pm maintenance).
na
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.
na
Requirement: Records of control and disposition of customer-supplied property shall be maintained.
na
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Product & Service Realization 5.20 ISO/API 8.5.4/5.7.6 ISO/API 8.5.4/5.7.6 ISO/API 8.5.4/5.7.6 ISO/API 8.5.4/5.7.6 ISO/API 8.5.4/5.7.6 ISO/API 8.5.4/5.7.6 ISO/API 8.5.4/5.7.6 5.21
Preservation of Product Doc. # **Requirement: Control features shall be established to preserve product conformity. **Requirement: Stock shall be checked at specified intervals to evaluate deterioration. Requirement: Conformity of product during internal processing and delivery to the intended destination shall be preserved. Requirement: Preservation of product shall include identification and traceability marks, transportation, handling, packaging, storage and protec Requirement: Preservation of product shall apply to the constituent parts of a product. Requirement: Designated storage areas or stock rooms shall be identified to prevent damage or deterioration of product prior to delivery. Requirement: Records of assessments of customer-supplied property shall be maintained.
COMPLY LEVEL
na na na na na na na
Control of Monitoring and Measuring Devices Doc. # Requirement: The organization shall determine the testing monitoring and measurement requirements and the associated equipment needed to provide evidence of conformity to those requirements.
na
ISO/API 7.1.5.2/5.8
Requirement: The organization shall maintain a documented procedure in order to ensure that testing, measurements and monitoring equipment is calibrated and maintained and that the equipment is used in a manner that is consistent with monitoring and measuring requirements.
na
ISO/API 7.1.5.2/5.8
Requirement: The procedure shall address: Unique identifier, calibration status, frequency of calibration, at specified intervals prior to use, traceability to international or nation measurement standards, where no such standard exists, that basis used for calibration or verification shall be recorded.
na
Requirement: The procedure shall address: Calibration and verification method, including adjustments and readjustments, as necessary; acceptance criterial
na
ISO/API 7.1.5.2/5.8
ISO/API 7.1.5.2/5.8 ISO/API 7.1.5.2/5.8 ISO/API 7.1.5.2/5.8 ISO/API 7.1.5.2/5.8
Requirement: Control of equipment identified as out-of-calibration in order to prevent unintended use
na
Requirement: Where necessary to ensure valid results, measuring equipment shall be: Calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards.
na
Requirement: When the equipment is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the equipment and product, including maintaining records and evidence of notification to the customer if suspect product has been shipped.
na
ISO/API 7.1.5.2/5.8
Requirement: Testing and measuring equipment shall be calibrated or verified, or both, against measured standards
ISO/API 7.1.5.2/5.8
Requirement: Testing and measuring equipment shall have calibration status identifiable by the user for activities being performed at all times.
na
Requirement: Testing and measuring equipment shall Be safeguarded from adjustments that would invalidate the measurement results or the calibration status.
na
Requirement: Testing and measuring equipment shall be protected from damage and deterioration during handling, maintenance and storage.
na
Requirement: Testing and measuring equipment shall be used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests being carried out.
na
ISO/API 7.1.5.2/5.8 ISO/API 7.1.5.2/5.8 ISO/API 7.1.5.2/5.8 ISO/API 7.1.5.2/5.8 ISO/API 7.1.5.2/5.8
Records shall be maintained supporting the results of calibration and verification. Requirement: When used in the monitoring and measurement of specified requirements, the ability of computer software shall satisfy the intended application.
na
na na
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Business Unit - Full Audit System Observations Minor Product & Service Realization
5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 5.10 5.11 5.12 5.13 5.14 5.15 5.16 5.17 5.18 5.19 5.20 5.21 5.22
Major
% Compliant
Activities
Before Correction
After Correction
Before Correction
After Correction
Before Correction
After Correction
9 4 9 5 11 9 7 5 2 6 5 22 5 5 0 0 0 0 0 0 0 0 104
1 0 0 0 0 1 0 4 0 0 0 19 1 0 0 0 0 0 0 0 0 0 26
8 4 9 4 12 8 7 1 2 6 5 6 5 5 28 9 7 6 5 7 17 7 168
0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 2
9 4 9 4 12 9 7 4 2 6 5 24 6 5 28 9 7 6 5 7 17 7 192
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
9 4 9 4 12 9 7 5 2 6 5 25 6 5 28 9 7 6 5 7 17 7 194
Planning of Product Realization Contract Review Review of Requirements Related to the Product Customer Communication Design and Development Planning Design and Development Inputs Design and Development Outputs Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes Purchasing Process Purchasing Information Verification of Purchased Product Control of Production and Service Provision Validation of Processes for Production and Service
Product Control Plan Identification & Traceabiltiy Customer Property Preservation of Product Control of Monitoring and Measuring Devices Inspection & Testing
Totals
% Compliant (Audit Score)
Scoring
% Compliant (Correction Score)
Total Audit Score
Audit Score
Correction Score
94.4% 100.0% 100.0% 100.0%
24200.0% #DIV/0! #DIV/0! #DIV/0!
100.0% 94.4% 100.0% 0.0% 100.0% 100.0% 100.0%
#DIV/0! 24200.0% #DIV/0! 1250.0% #DIV/0! #DIV/0! #DIV/0!
43.2% 90.0% 100.0% NA NA NA NA NA NA NA NA 81.7%
2600.0% 16100.0% #DIV/0! NA NA NA NA NA NA NA NA 13684.2%
Total Correction Score
30000.0% 24200% 16100%
15000.0%
Inspection & Testing
Control of Monitoring and Measuring Devices
Preservation of Product
Customer Property
Identification & Traceabiltiy
Product Control Plan
Validation of Processes for Production and Service
100%
Control of Production and Service Provision
2600% 43% 90%
Verification of Purchased Product
0%
100%
Purchasing Information
100%
Purchasing Process
1250% 100%
Control of Design and Development Changes
100%
Design and Development Validation
94%
Design and Development Verification
100%
Design and Development Review
100%
Design and Development Outputs
100%
Design and Development Inputs
100%
Design and Development Planning
94%
Review of Requirements Related to the Product
0.0%
Customer Communication
10000.0% 5000.0%
0 - 70%
24200%
20000.0%
Contract Review
71 - 85%
25000.0%
Planning of Product Realization
86 - 100%
Measurement, Analysis and Improvement (MAI) 6.1 ISO/API 10.1/6.1 ISO/API 10.1/6.1 ISO/API 10.1/6.1 ISO/API 10.1/6.1 ISO/API 10.1/6.1 6.2 ISO/API 9.1.2/6.2.1 ISO/API 9.1.2/6.2.1 ISO/API 9.1.2/6.2.1 ISO/API 9.1.2/6.2.1 ISO/API 9.1.2/6.2.1 6.3 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2
General *Requirement: Key Performance Indicators (KPI) shall be determined, measured; reported, and trend analyzed conducted on a continuous basis. Requirement: Processes implemented for MAI shall demonstrate conformity of the product. Requirement: Processes implemented for MAI shall ensure conformity of the quality management system. Requirement: Processes implemented for MAI shall continually improve the effectiveness of the quality management system.
COMPLY LEVEL
yes yes yes yes
Requirement: Processes implemented for MAI shall include the determination of applicable methods, including statistical techniques and the extent of their use.
yes
Customer Satisfaction Doc. # Requirement: A Customer Satisfaction Procedure shall be developed that addresses the documentation and frequency of measurements to meet customer requirements.
mi
Requirement: Customer Satisfaction Procedure shall address the method of documenting and obtaining customer feedback. Requirement: Customer Satisfaction Procedure shall address key performance indicators. Requirement: Customer Satisfaction Procedure shall address obtaining any additional information used to determine whether the facility has satisfied customers in meeting identified requirements. Requirement: Customer Satisfaction records shall be maintained. Internal Audit (IA) Doc. # Requirement: An Internal Audit procedure shall be developed to define responsibilities for planning, conducting, and documenting internal audits.
ob na ob ob
mi
Requirement: The Internal Audit Procedure shall address the planned intervals to determine the quality management system of outsourced activities that impact the quality of the product, and that are performed at the organization's facility.
na
Requirement: The Internal Audit Procedure shall address the planned intervals to determine the quality management system conforms to planned arrangements. At least every 12 months for API
yes
Requirement: Internal Audits shall be conducted at planned intervals to determine whether the quality management system conforms to the requirements of ISO 9001: and/or API Q1.
ob
Requirement: Internal Audits shall be conducted at planned intervals to determine whether the quality management system is effectively implemented and maintained.
ob
Requirement: Internal Audits shall be conducted at planned intervals to determine whether the quality management system conforms to quality, safety, and environmental management system of the organization.
na
Requirement: Internal Audits shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits and criticality of the process(as) being audited.
yes
Requirement: Internal Audits shall define the audit criteria, scope, frequency, and methods. Requirement: Auditors conducting the Internal Audits shall conduct audits ensuring objectivity and impartiality of the audit process.
ob yes
Requirement: A documented procedure shall be developed to address the responsibility and requirements for planning, conducting, reporting audit results and the method of maintaining audit records.
yes
Requirement: Management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.
mi
Requirement: Audit follow-up activities shall include the verification of the actions taken and the reporting of verification results.
yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Measurement, Analysis and Improvement (MAI) ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2 ISO/API 9.2/6.2.2
Requirement: Audits shall be conducted by competent personnel. Requirement: Audit follow-up activities shall include the validation of the actions taken and the reporting of validation results. Requirement: Results of internal audits and the status of corrective actions shall be reported in the management review. Requirement: The location and method of storage of Internal Audit records of internal audits shall be defined and maintained.
COMPLY LEVEL yes yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Measurement, Analysis and Improvement (MAI) 6.4 ISO/API 9.1.1/6.2.3 ISO/API 9.1.1/6.2.3 ISO/API 9.1.1/6.2.3 6.5 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10
ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10 ISO/API 8.7/5.10
Monitoring and Measurement of Processes Requirement: Suitable methods shall be applied for monitoring and measuring, where applicable, of the quality management system processes. Requirement: Monitoring and Measurement of methods shall demonstrate the ability of the processes to achieve planned results.
COMPLY LEVEL
yes yes
Requirement: When Monitoring and Measurement of planned results are not achieved, correction (short term solution) actions shall be taken as appropriate to ensure conformity of the product.
mi
Control of Nonconforming Product Doc. # Requirement: The facility shall identify the controls, related responsibilities, and authorities for addressing and documenting the nonconforming product.
yes
Requirement: A Control of Nonconforming Product procedure shall address nonconforming product identified during product realization and shall address product identification to prevent unintended use or delivery.
yes
Requirement: The Control of Nonconforming Product procedure shall identify during the product realization the detected nonconformity and taking action to preclude its intended use or delivery.
yes
Requirement: The Control of Nonconforming Product procedure shall identify during product realization the methods authorizing its use, release, or acceptance under concession by the relevant authority and, where applicable, by the customer.
yes
Requirement: The Control of Nonconforming Product procedure identifies after delivery the Identifying, Documenting, and Reporting of nonconformance's or product failures identified after delivery.
mi
Requirement: The Control of Nonconforming Product procedure shall address the controls for the nonconforming product identified after delivery: Ensuring the analysis of product nonconformance's or failure, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the case.
ob
Requirement: The Control of Nonconforming Product procedure shall address the controls for the nonconforming product identified after delivery: Taking the appropriate action to the effects, or potential effects, of the nonconformance when the nonconforming product is detected after delivery.
Requirement: The Control of Nonconforming Product procedure shall address how the organization shall perform one or more of the following: Repair or Rework with subsequent inspection to meet specified requirements of the nonconforming product. Requirement: The Control of Nonconforming Product procedure shall address how the organization re-grades the product for alternative applications.
Requirement: The Control of Nonconforming Product procedure shall address how the organization releases the nonconforming product under concession. Requirement: The Control of Nonconforming Product procedure shall address how the organization rejects or scraps the nonconforming product.
ob
yes
na
yes ob
Requirement: When nonconforming product is detected after delivery or use has started, actions shall be taken appropriate to the effects, or potential effects, of the nonconformity.
ob
Requirement: Relevant management and the customer shall authorize the release of the nonconforming product under concession when: Product continues to satisfy the applicable DAC and/or criteria.
na
Requirement: Relevant management and the customer shall authorize the release of the nonconforming product under concession when: The violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer criteria.
na
Requirement: Relevant management and the customer shall authorize the release of the nonconforming product under concession when: The DAC are changed, and the products satisfied the revised DAC and associated MAC requirements.
na
Requirement: The customer shall be notified of product not conforming to DAC or contract requirements that have been delivered. Requirement: Records of the nature of nonconformities and any subsequent action taken shall include concessions obtained.
na yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Measurement, Analysis and Improvement (MAI) ISO/API 8.7/5.10
COMPLY LEVEL yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Measurement, Analysis and Improvement (MAI) 6.6 ISO/API 9.1.3/6.3 ISO/API 9.1.3/6.3 ISO/API 9.1.3/6.3 ISO/API 9.1.3/6.3 ISO/API 9.1.3/6.3 ISO/API 9.1.3/6.3 ISO/API 9.1.3/6.3 ISO/API 9.1.3/6.3 ISO/API 9.1.3/6.3 6.7 ISO/API 10.3/6.4.1 ISO/API 10.3/6.4.1 6.8 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2 ISO/API 10.2/6.4.2
COMPLY LEVEL
Analysis of Data Doc. # Requirement: The organization shall define the methods & techniques used to ensure the proper collection & analysis of data. The analysis shall demonstrate the suitability and effectiveness of the QMS.
ob
Requirement: Appropriate data shall be determined, collected and analyzed to demonstrate the suitability and effectiveness of the quality, safety, and environmental management system in order to evaluate when continual improvement of the QMS can be made.
yes
Requirement: The analysis of data shall include data generated as a result of monitoring and measurement, internal audits, management reviews, and from other relevant sources.
yes
Requirement: The analysis of data shall provide information relating to customer satisfaction. Requirement: The analysis of data shall provide information relating to conformance to product requirements. Requirement: The analysis of data shall provide information relating to characteristics and trends of processes and products including opportunities for preventive action. Requirement: The analysis of data shall provide information relating to suppliers and their performance. Requirement: The analysis of data shall provide information relating to nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause. Requirement: The analysis of data shall provide information relating to quality objectives. Continual Improvement *Requirement: The effectiveness of the quality management system shall be continually improved throughout by the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. *Requirement: Process improvement activities shall be implemented and are ongoing. Corrective Action Doc. # **Requirement: A process shall be developed and is being used to verify the effectiveness of any corrective action taken. **Requirement: The response time for the submission of corrective action plans shall be identified. Requirement: Actions shall be taken to eliminate the cause of nonconformities in order to prevent recurrence. Requirement: Corrective actions appropriate to the effects of nonconformities shall be encountered. Requirement: A documented procedure shall be established to define requirements for reviewing nonconformities, including customer complaints. Requirement: A documented procedure shall be established to define requirements for determining the causes of nonconformities. Requirement: A documented procedure shall be established to define requirements for evaluating the need for action to ensure nonconformities do not reoccur. Requirement: A documented procedure shall be established to define requirements for determining and implementing action needed. Requirement: A documented procedure shall be established to define requirements for records of the result of action taken. Requirement: A documented procedure shall be established to define requirements for reviewing corrective action taken and update risks and opportunities determined during planning, if necessary
ob mi ob ob ob ob
yes yes
yes yes yes yes yes yes yes yes yes ob
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Measurement, Analysis and Improvement (MAI) 6.9 API 6.4.3 API 6.4.3 API 6.4.3
Preventive Action Doc. # **Requirement: A process shall be developed and is being used to verify the effectiveness of any preventive action taken. Requirement: Actions shall be determined to eliminate the causes of potential nonconformities in order to prevent their occurrence. Requirement: Preventive actions appropriate to the effects of potential problems shall be determined and documented.
COMPLY LEVEL
mi yes yes
Requirement: A documented procedure shall be established to define the requirement for evaluating the need for action to prevent the occurrence of nonconformities.
yes
API 6.4.3
Requirement: A documented procedure shall be established to define the requirement for determining potential nonconformities and their causes.
yes
API 6.4.3 API 6.4.3 API 6.4.3
Requirement: A documented procedure shall be established to define the requirement for determining and implementing action needed.
API 6.4.3
Requirement: A documented procedure shall be established to define the requirement for records of results of action taken. Requirement: A documented procedure shall be established to define the requirement for reviewing preventive action taken.
yes yes yes
RESPONSIBLE PARTY
CORRECTION TARGET DATE
DATE CORRECTED
Business Unit - Full Audit System Observations Minor 6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9
Measurement, Analysis and ImprovementActivities General Customer Satisfaction Internal Audit (IA) Control of Nonconforming Product Analysis of Data Continual Improvement Corrective Action Preventive Action Totals
Scoring
Before Correction
After Correction
Before Correction
After Correction
Audit Score
Correction Score
0 3 3 0 4 6 0 1 0 17
5 5 13 3 13 3 2 9 8 61
0 1 2 1 1 1 0 0 1 7
5 4 14 2 16 8 2 10 7 68
0 0 0 0 0 0 0 0 0 0
5 5 16 3 17 9 2 10 8 75
100.0% 0.0% 46.4% 0.0% 58.3% 33.3% 100.0% 95.0% 62.5% 56.0%
#DIV/0! 1433.3% 2780.0% 1250.0% 4490.0% 1925.0% #DIV/0! 26900.0% 3500.0% 3337.3%
% Compliant (Audit Score)
86 - 100%
30000.0%
71 - 85%
25000.0%
0 - 70%
20000.0%
% Compliant
After Correction
5 4 14 3 12 9 2 10 8 67
Monitoring and Measurement of Processes
Major
Before Correction
% Compliant (Correction Score)
Total Audit Score
Total Correction Score
26900%
15000.0% 10000.0% 5000.0% 0.0%
1433%
100% 0%
4490%
2780%
1250%
46% 0%
58%
1925% 33%
3500% 100%
95%
63%
View more...
Comments
