API Specification Q1 Audit checklist
The following checklist can be used for both internal audits as well as Gap Analysis tools.
| API Specification Q1 Internal Audit checklist | |
| 4.0 | Quality Management System Requirements |
| 4.1 | Quality Management System |
| 4.1.1 | General |
| 1 | How does the organization plan, establish, document, implement, and maintain a quality management system at all times in accordance with the requirements of this specification for the product provided within the scope defined by the organization? |
| 2 | How does the organization measure the effectiveness the quality management system by the requirements of API Specification Q1? |
| 3 | How does the organization improve upon the quality management system by the requirements of API Specification Q1? |
| 4.1.2 | Quality Policy |
| 1 | Has the organization established a Quality policy for its commitment to quality? |
| 2 | How does the organization ensure that Quality policy is appropriate to the organization? |
| 3 | Does the organization’s top management review the quality policy periodically? |
| 4 | How does the organization ensures that Quality policy is appropriate to the organization? |
| 5 | How does the organization ensure that Quality policy supports its strategic direction? |
| 6 | How does the organization ensures that Quality policy is the basis for the development of quality objectives? |
| 7 | How does the organization ensure that Quality policy is communicated, understood, implemented, and maintained within the organization? |
| 8 | How does the policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system? |
| 9 | How does oes the policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system? |
| 4.1.3 | Quality Objectives |
| 1 | Are the Quality objectives measurable? |
| 2 | How does the management ensure that quality objectives meet product and customer requirements? |
| 3 | How does the management ensure that quality objectives are established at relevant functions and levels within the organization? |
| 4 | How does the Management Representative ensure the initiation of action(s) to minimize the likelihood of the occurrence of nonconformities? |
| 5 | Are the Quality objectives measurable? |
| 6 | Is the Quality objectives measurable? |
| 7 | How does the management ensure the planning of the quality management system is carried out to meet the requirements of API Specification Q1? |
| 4.1.4 | Planning |
| 4.1.4.1 | General |
| 1 | How is the planning of the quality management system performed? |
| 2 | How is the planning of the quality management system performed? |
| 3 | How does the organization identify external and internal issues relevant to the organization’s long-term or overall objectives and goals? |
| 4 | How does the organization determine relevant interested parties and their requirements for the quality management system? |
| 5 | How does the organization determine the sequence and interaction between the processes of the quality management system? |
| 6 | How does the organization determine and manage the criteria and methods needed for the effective operation and control of quality management system processes? |
| 7 | How does the organization identify quality objectives, including actions, resources, responsibilities, and timeframe, and how results are monitored and evaluated? |
| 8 | How does the organization address identified risks? |
| 9 | How does the organization address identified opportunities for improvement? |
| 10 | How does the organization identify key personnel? |
| 4.1.4.2 | Exclusions |
| 1 | Has the organization claimed any exclusions to any sections of API Q1 specification Q1 and will the exclusions be limited to the following sections of this specification: — 5.4, Design — 5.6.4, Validation of Processes — 5.6.7, Externally Owned Property — 5.8, Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) |
| 2 | Where any exclusions are claimed, are the justifications documented? |
| 3 | How does the organization ensure that Excluded activities do not affect the organization’s ability, or responsibility, to provide products that satisfy customer and legal requirements? |
| 4 | Has the organization ensured that there are no claims to exclusion of activities addressed by this specification, including outsourced activities, if an organization performs them? |
| 4.1.5 | Communication |
| 4.1.5.1 | Internal |
| 1 | How does the management ensure that appropriate communication processes are established within the organization? |
| 2 | How does the organization establish processes to ensure that the results of analysis of data are communicated at relevant levels and functions within the organization? |
| 3 | How does the organization establish processes to ensure that the results of analysis of data are communicated at relevant levels and functions within the organization? |
| 4.1.5.2 | External |
| 1 | Has the organization established and implemented the process for communicating with external organizations, including customers? |
| 2 | How does the communication process address the execution of inquiries, contracts, or order handling and amendments? |
| 3 | How does the organization determine and understand the requirements throughout contract execution and product realization? |
| 4 | How does the communication process address the provision of product information, including nonconformities? |
| 5 | How does the communication process address feedback and customer complaints? |
| 6 | How does the organization communicate quality plans and subsequent changes to those plans? |
| 7 | How does the organization communicate changes and associated risks? |
| 4.2 | Management Responsibility |
| 4.2.1 | General |
| 1 | How does the top management demonstrate leadership and commitment to the establishment, implementation, maintenance, and improvement of the quality management system? |
| 2 | How does the top management ensure that quality objectives are established at relevant functions and levels within the organization? |
| 3 | How does the top management provide the resources needed for the quality management system? |
| 4 | How does the top management engage and support personnel in the implementation and maintenance of quality management systems? |
| 5 | How does the top management assign responsibilities and authorities for ensuring the processes achieve intended outputs? |
| 4.2.2 | Responsibility and Authority |
| 1 | Are the responsibilities, authorities, and accountabilities of personnel within the scope of the Quality Management System defined, documented, and communicated throughout the organization? |
| 4.2.3 | Management Representative |
| 1 | Has the top management appointed and maintained a member of the organization’s management as a Management Representative? |
| 2 | Has the top management ensured that the quality management system conforms to the requirements of this specification? |
| 3 | How does the Management Representative ensure that processes needed for the quality management system are established, implemented, and maintained? |
| 4 | How does the Management Representative report to top management on the performance of the quality management system and any need for improvement? |
| 5 | How does the organization determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system? |
| 6 | How does the organization determines and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system? |
| 4.3 | Organization Capability |
| 4.3.1 | Resources and Knowledge |
| 4.3.1.1 | Resources |
| 1 | How does the organization determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system? |
| 4.3.1.2 | Knowledge |
| 1 | How does the organization determine the knowledge needed to provide continued operation of its processes? |
| 2 | How does the organization determine the knowledge needed to achieve ongoing conformity of products? |
| 3 | How does the organization maintain this knowledge and make it available? |
| 4.3.2 | Human Resources |
| 4.3.2.1 | Personnel Competence |
| 1 | Does the organization ensure that its personnel whose responsibilities fall within the scope of the quality management system are competent? |
| 2 | Is there a documented procedure addressing personnel competence that the organization shall maintain? |
| 3 | Does the procedure include how required competencies are identified and documented? |
| 4 | Does the procedure include how required education, training, experience, or other actions to achieve competence are identified? |
| 5 | Does the procedure include an evaluation of the effectiveness of actions taken to acquire competencies? |
| 6 | Does the procedure include criteria and methods for assessing, maintaining and, re-assessing competencies? |
| 7 | Does the procedure include personnel responsible for assessing competency? |
| 8 | Are the records of personnel competence maintained? |
| 4.3.2.2 | Training |
| 1 | How does the organization develop and maintain a procedure for training? |
| 2 | How does the organization identify the content and frequency of training required? |
| 3 | How does the organization address the provision of quality management system training? |
| 4 | How does the organization address the provision of job training including personnel awareness of the relevance and importance of their activities and how they contribute to the achievement of the organization’s quality objectives ? |
| 5 | How does the organization provide customer-specified training and/or customer-provided training, when required? |
| 6 | How does the organization evaluate of effectiveness of training? |
| 7 | How does the organization identify the required training records? |
| 8 | Does the organization maintain appropriate records of personal training? |
| 4.3.3 | Work Environment |
| 1 | How does the organization determine, provide, manage, and maintain the work environment needed to achieve conformity of the product? |
| 2 | Does the work environment include a) buildings, workspace, and associated utilities; b) process equipment (both hardware and software) ; c) supporting services (e.g. transport, communication, information systems); and d) conditions under which work is performed such as physical, environmental, or other factors. |
| 4.4 | Documentation Requirements |
| 4.4.1 | General |
| 1 | Does the quality management system documentation include the scope of the quality management system that identifies the products covered, including justification for any exclusions? |
| 2 | Does the quality management system documentation includes statements of quality policy and quality objectives? |
| 3 | Does the quality management system documentation include the identification of legal and other applicable requirements to which the organization claims compliance that is needed to achieve product conformity? |
| 4 | Does the quality management system documentation include identification of how the quality management system addresses each requirement of API Q1? |
| 5 | Does the quality management system documentation include identification of processes that require validation? |
| 6 | Does the quality management system documentation include documented procedures established for the quality management system? |
| 7 | Does the quality management system documentation include documents and records to ensure the effective planning, operation, and control of its processes and compliance with specified requirements? |
| 4.4.2 | Procedures |
| Are all procedures referenced within API Specification Q1 describing the organization’s method for performing an activity and documented, implemented, and maintained for continued suitability? | |
| 4.4.3 | Control of Documents |
| 1 | Does the organization maintain a documented procedure for the identification, distribution, and control of internal documents required by the quality management system and API Specification Q1, including revisions, translations, and updates? |
| 2 | Does the procedure specify responsibilities for approval and re-approval? |
| 3 | Does the procedure specify the review and approval for adequacy prior to issue and use? |
| 4 | Does the procedure specify the review for continued suitability and revision(s) as necessary? |
| 5 | Does the procedure specify the identification of changes and current revision status? |
| 6 | Does the procedure specify the legibility and identification of documents? |
| 7 | Does the procedure identify the controls needed to ensure that the documents required by the quality management system are available where the activity is being performed? |
| 8 | How are obsolete documents removed from all points of issue or use, or otherwise identified to ensure against unintended use if they are retained for any purpose? |
| 9 | How are Procedures, work instructions, and forms required by the quality management system controlled? |
| 4.4.4 | Use of External Documents in Product Realization |
| 1 | Does the organization maintain a documented procedure for the control of documents of external origin required for product realization and used by the organization, including API or other external specifications? |
| 2 | Does the procedure address identification and documentation of required documents? |
| 3 | Does the procedure address access and distribution of required documents, including relevant versions? |
| 4 | Does the procedure address the integration of requirements into product realization and any other affected processes? |
| 5 | Does the procedure address the process for identifying when changes to required documents have occurred, including addenda, errata, and updates? |
| 6 | Does the procedure address the integration of applicable changes? |
| 7 | Does the organization maintain a documented procedure to identify the controls and responsibilities needed for records? |
| 4.5 | Control of Records |
| 1 | Are records, including those originating from outsourced activities, established and controlled to provide evidence of conformity to requirements and the organization’s quality management system? |
| 2 | How does the organization address record identification, collection, legibility, correction, storage, protection from unintended alteration, damage, loss, retrieval, retention time, and disposition? |
| 3 | How does the organization address record identification, collection, legibility, correction, storage, protection from unintended alteration, damage, or loss, retrieval, retention time, and disposition? |
| 4 | Are the records retained for a minimum of ten years or as required by the customer, legal, and other applicable requirements, whichever is longer? |
| 5.0 | Product Realization |
| 5.1 | Contract Review |
| 5.1.1 | General |
| 1 | Does the organization maintain a documented procedure for the review of requirements related to the provision of products? |
| 2 | Does the procedure address the determination of requirements, review of requirements; and changes to requirements? |
| 5.1.2 | Determination of Requirements |
| 1 | How does the organization determine the requirements specified by the customer? |
| 2 | How does the organization determine the legal and other applicable requirements? |
| 3 | How does the organization determine the requirements not stated by the customer but considered necessary by the organization for the provision of the product? |
| 4 | Where the customer provides no documented statement of the requirements, is the customer requirements confirmed by the organization and records maintained? |
| 5.1.3 | Review of Requirements |
| 1 | How does the organization review the requirements related to the provision of products? |
| 2 | Is this review conducted before the organization‘s commitment to deliver the product to the customer? |
| 3 | How does the organization ensure that requirements are identified and documented? |
| 4 | How does the organization ensure that requirements differing from those previously identified are resolved? |
| 5 | How does the organization ensure that the organization can meet the documented requirements? |
| 6 | Where contract requirements are changed, how does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements? |
| 7 | Are the records of the results of the review, including resulting actions, maintained? |
| 5.2 | Planning |
| 1 | Has the organization identified and planned the processes and documents needed for product realization? |
| 2 | How does the organization plan for required resources and work environment management? |
| 4 | How does the organization plan for the product and customer-specified requirements? |
| 5 | How does the organization plan for the legal and other applicable requirements? |
| 6 | How does the organization plan for the contingency? |
| 7 | How does the organization plan for the design requirements? |
| 8 | How does the organization plan for the required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for acceptance? |
| 9 | How does the organization plan for management of change (MOC)? |
| 10 | How does the organization plan for the records needed to provide evidence that the product realization conforms to requirements? |
| 11 | Is the output of planning documented? |
| 12 | Is the output of planning updated as changes occur? |
| 13 | Are the plans maintained in a structure suitable for the organization‘s method of operations? |
| 5.3 | Risk Management |
| 5.3.1 | General |
| 1 | Does the organization maintain a documented procedure to identify and control risks associated with product delivery and product quality? |
| 2 | Does the procedure address risk identification and assessment techniques? |
| 3 | Does the procedure address risk assessment tools and their application? |
| 4 | Is the criteria to determine risk severity including potential consequences of product failure established? |
| 5 | Does the procedure address risk mitigation actions? |
| 6 | Does the procedure address the assessment of remaining risk? |
| 7 | Does the organization maintain a documented procedure for identifying, verifying, safeguarding, preserving, maintaining, and controlling customer-supplied property, including intellectual property and data, while under the control of the organization? |
| 5.3.2 | Risk Assessment |
| 5.3.2.1 | Product delivery |
| 1 | Does Risk assessment associated with product delivery include facility/equipment availability including maintenance? |
| 2 | Does Risk assessment associated with product delivery include supplier delivery performance and material availability/supply? |
| 5.3.2.2 | Product Quality |
| 1 | Does the Risk assessment associated with product quality include delivery of nonconforming products? |
| 2 | Does the Risk assessment associated with product quality include the availability of competent personnel? |
| 5.3.2.3 | Changes Impacting Product Quality |
| 1 | If any changes can negatively impact the quality of the product, does the organisation perform a risk assessment associated with product quality? |
| 2 | Is a risk assessment associated with product quality performed when there are changes in the organizational structure? |
| 3 | Is a risk assessment associated with product quality performed when there are changes in key personnel? |
| 4 | Is a risk assessment associated with product quality performed when there are changes in the supply chain of critical products, components, or activities? |
| 5 | Is a risk assessment associated with product quality performed when there are changes to the management system scope or procedures? |
| 6 | Is a risk assessment associated with product quality performed when there are changes to the organization’s capability to perform the process(es) required for product realization? |
| 5.3.3 | Contingency Planning |
| 1 | Has the organization determined any contingency plan based on assessed risk? |
| 2 | Does the contingency plan include actions required to reduce the effects of disruptive incidents? |
| 3 | Does the contingency plan include the identification and assignment of responsibilities and authorities? |
| 4 | Does the contingency plan include internal and external communication controls? |
| 5 | Is the contingency plan documented, communicated to the relevant personnel, and updated as needed? |
| 5.3.4 | Records |
| Are the Records of risk assessment and management including actions taken maintained? | |
| 5.4 | Design |
| 5.4.1 | General |
| 1 | In case the organization is responsible for the design of products, have the requirements of 5.4 applied? (The design requirements of 5.4 is not applied if the product is in production activities, servicing, storage, distribution, or logistics) |
| 5.4.2 | Design Planning |
| 1 | Does the organization maintain a documented procedure to plan and control the design process? |
| 2 | Does the procedure identify the plans, including plan updates, used for design? |
| 3 | Does the procedure identify the design stages? |
| 4 | Does the procedure identify the resources, responsibilities, authorities, and their interfaces? |
| 5 | Does the procedure identify the review, verification, and validation activities necessary to complete each design stage? |
| 6 | Does the procedure identify the requirements for a final review of the design? |
| 7 | Does the procedure identify the review and approval requirements for design changes? |
| 8 | When design activities are outsourced or performed at different locations within the organization, does the procedure identify the controls required to ensure that the designs meet the requirements of 5.4 Design? |
| 9 | When design and development are outsourced, how does the organization ensure the supplier meets the requirements of 5.5.1.7 outsourcing? |
| 5.4.3 | Design Inputs |
| 1 | How does the organization identify and review the Inputs for adequacy, completeness, lack of ambiguity and lack of conflict? |
| 2 | How are any issues identified are addressed? |
| 3 | Does the Inputs include functional and technical requirements? |
| 4 | Do the Inputs include customer-specified requirements? |
| 5 | Do the Inputs include requirements provided from external sources, including API product specifications? |
| 6 | Do the Inputs include environmental and operational conditions? |
| 7 | Do the Inputs include methodology, assumptions, and formulae documentation? |
| 8 | Do the Inputs include historical performance and other information derived from previous similar designs? |
| 9 | Do the Inputs include legal requirements? |
| 10 | Do the Inputs include consequences of potential product failure when required by legal requirements, industry standards, customers, or deemed necessary by the organization? |
| 11 | Are the records of design inputs maintained? |
| 5.4.4 | Design Outputs |
| 1 | How does the organization document its output to allow verification against the design input requirements? |
| 2 | Does the output meet the input requirements for design? |
| 3 | Does the output provide information for purchasing, production, inspection, testing and servicing as applicable? |
| 4 | Does the output identify or refer to design acceptance criteria (DAC)? |
| 5 | Does the output include identification of, or reference to, products and/or components deemed critical to the design? |
| 6 | Does the output include the results of applicable calculations? |
| 7 | Does the output specify the characteristics of the product that are essential for its safe and proper use? |
| 8 | Are the Records of design outputs maintained? |
| 5.4.5 | Design Review |
| 1 | Are Design Reviews performed at suitable stages? |
| 2 | Are reviews performed to evaluate the suitability, adequacy, and effectiveness of the results of design and development stages to meet specified requirements? |
| 3 | Are reviews performed to identify any problems and propose necessary actions? |
| 4 | Do participants in such review(s) include representatives of functions concerned with the design stage(s) being reviewed? |
| 5 | Are the records of the results of the review(s) and any necessary actions maintained? |
| 5.4.6 | Design Verification and Final Review |
| 1 | To ensure that the design outputs have met the design input requirements, how does the organization ensure that design and development verification and a final review are conducted and documented as identified within the organization’s procedure? |
| 2 | Are the records of design verification, any necessary actions and the final review maintained? |
| 5.4.7 | Design Validation and Approval |
| 1 | Are Design and development validation performed in accordance with the organization’s procedure? |
| 2 | How does the organization ensure that the Design validation of the resulting product is capable of meeting the specified requirements? |
| 3 | When possible does the organization ensure that validation is completed prior to the delivery of the product? |
| 4 | How does the organization ensure that the completed design is approved after validation? |
| 5 | How does the organization ensure that Competent individual(s) other than the person or persons who developed the design approve the final design? |
| 6 | Are records of the design and development validation, approval, and any necessary actions maintained? |
| 5.4.8 | Design Changes |
| 1 | How are Design changes identified? |
| 2 | How does the organization ensure that the changes are reviewed, verified, and validated, as appropriate, and approved before implementation? |
| 3 | How does the organization ensure that the review of design changes includes an evaluation of the effect of the changes on the product and their constituent parts in affected stages of product realization, as well as the product already delivered? |
| 4 | Does the review of design changes include an evaluation to determine if customer notification is required when design changes negatively affect the specified performance capability of the product? |
| 5 | How does the organization ensure that the design and development changes, including changes to design documents, are in accordance with the organization’s procedure? |
| 6 | Are the records of design and development changes, reviews of those changes, and any necessary actions maintained? |
| 5.5 | Purchasing |
| 5.5.1 | Purchasing Control |
| 5.5.1.1 | Procedure |
| 1 | Does the organization maintain a documented procedure for the purchase of products, components, and/or activities required for product realization? |
| 2 | Does the procedure determine the critical products, components, and/or activities? |
| 3 | Does the procedure address the initial evaluation and selection of suppliers? |
| 4 | Does the procedure address the use of identified risk to determine the initial assessment method of the supplier’s capability for critical purchases? |
| 5 | Does the procedure address the type and extent of control applied to the supply chain for critical products, components, or activities? |
| 5 | Does the procedure address criteria, scope, frequency, and methods for re-evaluation of suppliers? |
| 6 | Does the procedure address the identification of approved suppliers and the scope of approval? |
| 7 | Does the procedure address identification of customer-specified suppliers and suppliers limited by proprietary, and/or legal requirements when 5.5.1.3 (Initial Supplier Evaluation – Critical Purchases – Customer Specified, Proprietary, and/or Legal Limited) applies? |
| 5.5.1.2 | Initial Supplier Evaluation—Critical Purchases |
| 1 | For the purchase of critical products, components or activities, does the initial evaluation of suppliers (not previously approved) address the scope of supply, and are site-specific for each supplier? |
| 2 | Does the initial Supplier Evaluation for Critical Purchases include the verification of the supplier’s quality management system implementation and conformity to the quality system requirements specified for suppliers by the organization? |
| 3 | Does the initial Supplier Evaluation for Critical Purchases include verification of the type and extent of control applied by the supplier, internally and to their supply chain, to meet the organization’s requirements? |
| 4 | Does the initial Supplier Evaluation for Critical Purchases include an assessment of the supplier’s capability to meet the organization’s specified requirements by one or more of the following based on identified risk? |
| 5 | Does the initial Supplier Evaluation for Critical Purchases include performing an on-site assessment to verify that relevant product realization processes are being performed in accordance with process controls, and are effective in achieving conformity to requirements, performing an on-site evaluation of relevant activities? |
| 6 | Does the initial Supplier Evaluation for Critical Purchases include performing a remote assessment to verify that relevant product realization processes are being performed in accordance with process controls and are effective in achieving conformity to requirements? |
| 6 | Does the initial Supplier Evaluation for Critical Purchases include performing inspection, testing, or verification of relevant characteristics of a received product? |
| 7 | How does the organization ensure that the suppliers of critical purchases with high-risk severity identified by the organization for which an on-site assessment is not performed, the assessment of the supplier’s capability includes performing a remote assessment and performing inspection, testing, or verification? |
| 8 | When remote assessment is performed, does it include verification of objective evidence through real-time audio/visual observation of required activities and documentation using information and communication technology? |
| 9 | Does the evaluation of a supplier be performed in accordance with the requirements of this section for any additions to a supplier’s scope of approval or change from an approved site to a new site of supply? |
| 5.5.1.3 | Initial Supplier Evaluation – Critical Purchases – Customer Specified, Proprietary, and/or Legal Limited |
| 1 | For the purchase of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements does the initial evaluation include a) verification of the supplier’s quality management system implementation and conformity to the quality system requirements specified for suppliers by the organization and/or the customer’s requirements; and b) identifying how the supplied product, component or activity conforms to specified requirements. |
| 2 | How does the organization ensure that the scope of approval for customer-specified suppliers shall be limited to the relevant customer contract when assessment per 5.5.1.2, Item c) has not been performed? |
| 5.5.1.4 | Initial Supplier Evaluation—Noncritical Purchases |
| 1 | For the purchase of noncritical products, components, or activities that impact product realization or the final product, do the criteria for evaluation of suppliers by the organization meet the requirements as that of initial Supplier Evaluation for Critical Purchases or satisfy one of the following a) verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization; b) assessment of the supplier to meet the organization’s purchasing requirements; c) assessment of the product upon delivery or activity upon completion |
| 5.5.1.5 | Supplier Reevaluation |
| 1 | For previously approved suppliers of products, components, or activities, has the organization determined the supplier reevaluation frequency based on identified risk and supplier quality performance? |
| 2 | For the re-evaluation of suppliers of critical products, components or activities, have the requirements of 5.5.1.2 been applied? |
| 3 | For the re-evaluation of suppliers of critical products, components or activities for customer-specified suppliers and suppliers limited by proprietary, and/or legal requirements, have the requirements of 5.5.1.3 been applied? |
| 4 | For the re-evaluation of suppliers of noncritical products, components, or activities that impact product realization or the final product, have the requirements of 5.5.1.4 been applied? |
| 5.5.1.6 | Records |
| 1 | Are the Records of the results of all evaluations including objective evidence and any necessary actions arising from the evaluations maintained? |
| 2 | Are the Records of identification of approved suppliers, customer-specified suppliers, and suppliers limited by proprietary, and/or legal requirements shall be maintained? |
| 5.5.1.7 | Outsourcing |
| 1 | How does the organization maintain responsibility for product conformance to specified requirements, including applicable API product specifications, associated with product realization? |
| 2 | How does the organization maintain responsibility for product conformance to specified requirements, including applicable API product specifications or other external specifications? |
| 3 | Are the Records of outsourced activities maintained and include evidence of conformity? |
| 5.5.2 | Purchasing Information |
| 1 | How does the organization ensure the adequacy of specified purchasing information before their communication with the supplier? |
| 2 | Are the Purchasing information provided to the supplier documented and describes the product or activity to be purchased, including acceptance criteria? |
| 3 | Does the Purchasing information describe requirements for approval of the supplier’s procedures, processes, and equipment? |
| 4 | Does the Purchasing information describe the applicable version of specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data? |
| 5 | Does the Purchasing information describe requirements for the qualification of supplier’s personnel? |
| 6 | Does the Purchasing information describe requirements for the qualification of the supplier’s personnel? |
| 7 | Does the Purchasing information describe the requirements for approval of product release? |
| 8 | Does the Purchasing information describe if the organization or its customer intends to perform verification at the supplier’s premises, the intended verification arrangements? |
| 5.5.3 | Verification of Purchased Products, Components or Activities |
| 5.5.3.1 | General |
| 1 | Does the organization maintain a documented procedure defining the verification for determining whether purchased products components or activities conform to specified purchase requirements? |
| 5.5.3.2 | Critical Purchases |
| 1 | For critical products, components or activities, has the organization established the procedure for verification? |
| 2 | Does the procedure address the review of the organization’s required documentation from the supplier? |
| 3 | Does the procedure address the verification that the applicable versions are used when specifications, drawings, process requirements, inspection instructions, traceability requirements, and other relevant technical data are specified? |
| 4 | Does the procedure address the inspection, testing and/or verification requirements including methods, frequency, and responsible party.? |
| 5 | Does the organization determine the methods, frequency, and responsible party based on identified risk and supplier quality performance? |
| 5.5.3.3 | Noncritical Purchases |
| 1 | In accordance with the organization’s documented procedure, does the organisation verify Non-critical products, components or activities? |
| 5.3.3.4 | Records |
| 1 | Are the Records of verification activities and evidence of conformity to specified requirements maintained? |
| 5.6 | Control of Product Realization |
| 5.6.1 | General |
| 1 | Does the organization maintain a documented procedure that describes controls associated with the product realization? |
| 2 | In the procedure, has the organization determined and implemented the manufacturing acceptance criteria (MAC)? |
| 3 | Has the organization identified and documented of processes critical to product realization? |
| 4 | Does the procedure address the implementation of the product quality plan, when applicable? |
| 5 | Does the procedure address conformance of design requirements and related changes, when applicable? |
| 6 | Does the procedure address the availability and use of product realization equipment and TMMDE, unless it has been excluded? |
| 7 | Does the procedure address the use of applicable work instructions? |
| 8 | Does the procedure address process control documents? |
| 9 | Does the procedure address the implementation of monitoring and measurement activities? |
| 10 | Does the procedure address implementation of product release including applicable delivery and post-delivery activities? |
| 11 | Does the procedure address review and control of product realization changes, required approvals, and records? |
| 5.6.2 | Quality Plans |
| 1 | When required by contract, has the organization developed a quality plan that specifies the processes of the quality management system (including the product realization processes) and the resources to be applied to a product? |
| 2 | Does the Quality plan address the product description or scope of the quality plan? |
| 3 | Does the Quality plan address the required processes and documentation, including required inspections, tests, and records, for conformance with requirements? |
| 4 | Does the Quality plan address the identification of outsourced activities and reference to control? |
| 5 | Does the Quality plan address the identification of each procedure, specification, or other document referenced or used in each activity? |
| 6 | Does the Quality plan address the identification of the required hold, witness, monitor, and document review points? |
| 7 | Are the quality plans and any revisions to it are documented and approved by the organization? |
| 8 | Are the quality plans and any revisions communicated to the customer? |
| 5.6.3 | Process Control Documents |
| 1 | Has the organization documented process controls? |
| 2 | Does the process control include or refer to requirements for verifying conformance with applicable quality plans, API product specifications, customer requirements, and/or other applicable product standards/codes; |
| 3 | Does the process control include or refer to instructions and acceptance criteria for processes, tests, and inspections? |
| 4 | Where applicable, Does the process control include or refer to the customer’s inspection hold, witness, monitor, and document review points? |
| 5.6.4 | Validation of Processes |
| 1 | Does the organization validate processes when the resulting output cannot be verified by subsequent monitoring or measurement, and consequently, deficiencies become evident after the product has been delivered or are in use? |
| 2 | Does validation demonstrate the ability of these processes to achieve planned results? |
| 3 | Do only the processes specified in a product specification require validation for the applicable product? |
| 4 | Does the organization validate the following process: — nondestructive examination (NDE)/nondestructive test (NDT); — welding; — heat treating; and — coating and plating (when identified by the product specification or by the organization as critical to product performance). |
| 5 | Does the organization have a documented procedure for the validation of processes, including the methods used for review and approval? |
| 6 | Does the procedure include the required equipment? |
| 7 | Does the procedure include the qualification of personnel? |
| 8 | Does the procedure include the use of specific methods, including identified operating parameters? |
| 9 | Does the procedure include the identification of process acceptance criteria? |
| 10 | Does the procedure include the requirements for records? |
| 11 | Does the procedure include the revalidation? |
| 12 | Does the organization need to maintain evidence that the requirements of 5.6.4 Validation of process have been satisfied if it outsources a process that requires validation? |
| 5.6.5 | Identification and Traceability |
| 1 | Has the organization established and maintained identification throughout product realization, including applicable delivery and post-delivery activities? |
| 2 | Has the organization identified the traceability requirements as specified by the organization, the customer, and/or the applicable product specifications? |
| 3 | Has the organization maintained a documented procedure for identification and traceability while the product is under the control of the organization? |
| 4 | Does the documented procedure address the methods of identification? |
| 5 | Does the documented procedure address when required, information needed for traceability? |
| 6 | Does the documented procedure address the requirements for maintenance and/or reapplication of identification and/ or traceability? |
| 7 | Does the documented procedure address the actions required to address loss of identification and/or traceability? |
| 8 | Are the Records of traceability maintained? |
| 5.6.6 | Inspection/Test Status |
| 1 | Does the organization have a documented procedure for identifying inspection and/or test status throughout product realization, indicating product conformity or nonconformity? |
| 5.6.7 | Externally Owned Property |
| 1 | Does the organization maintain a documented procedure for controlling externally (including customer) owned property that is incorporated into the product while the property is under the organization’s control? |
| 2 | Does the Externally owned property include intellectual property and data that are not publicly available? |
| 3 | Does the procedure address identification, verification, safeguarding, preservation, maintenance; and reporting loss, damage, or unsuitability for use to the external owner? |
| 4 | Are the Records for the control and disposition of externally owned property maintained? |
| 5.6.8 | Preservation of Product |
| 1 | Does the organization maintain a documented procedure for describing the methods used to preserve the product and constituent parts throughout product realization and delivery? |
| 2 | Does the procedure address identification and traceability marks? |
| 3 | Does the procedure address storage, including the use of designated storage areas or stock rooms? |
| 4 | Does the procedure address the assessment of conditions at intervals specified by the organization? |
| 5 | Does the procedure address transportation;? |
| 6 | Does the procedure address handling? |
| 7 | Does the procedure address packaging? |
| 8 | Does the procedure address Protection? |
| 9 | Are the records of the results of assessments maintained? |
| 5.6.9 | Inspection, Testing, and Verification |
| 5.6.9.1 | General |
| 1 | Does the organization maintain a documented procedure for inspection, testing and /or verification of the product to confirm that requirements have been met? |
| 2 | Does the procedure address in-process inspection, testing, and/ or verification methods and their application? |
| 3 | Does the procedure address final inspection, testing, and/or verification methods and their application? |
| 4 | Are the records created and retention? |
| 5.6.9.2 | In-process Inspection, Testing, and Verification |
| 1 | Does the organization inspect, test, and/or verify products at planned stages as required by the quality plan, process control documents and/or documented procedures? |
| 2 | Are the evidence of conformity with the acceptance criteria maintained? |
| 5.6.9.3 | Final Inspection, Testing, and Verification |
| 1 | Does the organization perform final inspection, testing, and/or verification of the product in accordance with the quality plan, process control documents, and/or documented procedures to determine and document conformity of the finished product to the specified requirements? |
| 2 | Unless performed by an automated system, do personnel other than those who performed or directly supervised the product realization perform final acceptance inspection at planned stages of the product realization process? |
| 5.6.9.4 | Records |
| 1 | Are the Records of all required inspection, testing, verification, and final acceptance maintained? |
| 5.6.10 | Preventive Maintenance |
| 1 | Does the organization maintain a documented procedure for preventive maintenance of equipment used for product realization? |
| 2 | Does the procedure address the requirements for the type of equipment to be maintained, frequency of Preventive Maintenance and Responsible personnel? |
| 3 | Are the Records of preventive maintenance maintained? |
| 5.7 | Product Release |
| 1 | Has the organization maintained a documented procedure to address the release of products to the customer? |
| 2 | How do the organization ensure that the release shall not proceed until the planned arrangements have been satisfactorily completed? |
| 3 | How does the organization ensure that it releases products that conform to requirements or that are authorized under concession? |
| Are the records maintained to enable identification of the individual releasing the product? | |
| 5.8 | Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) |
| 5.8.1 | General |
| 1 | How does the organization determine the testing, measuring, monitoring, and detection requirements and the TMMDE needed to provide evidence of conformity to those requirements? |
| 2 | Does the organization ensure that TMMDE owned and maintained by the organization, employee-owned equipment, and TMMDE from other sources (e.g. third-party, proprietary, and customer-owned) used to provide evidence of product conformity and/or monitor process parameters identified by the organization that impact product conformance are controlled.? |
| 3 | Are TMMDE calibrated at specified intervals? |
| 4 | When the specified interval is based on the date of first use, is the date of first use documented? |
| 5.8.2 | Procedure |
| 1 | Does the organization maintain a documented procedure for the control of TMMDE? |
| 2 | Does the procedure include requirements for the specific equipment type? |
| 3 | Does the procedure address unique identification? |
| 4 | Does the procedure address calibration status? |
| 5 | Does the procedure address traceability to international or national measurement standards? |
| 6 | Where no such standards exist, is the basis used for calibration recorded? |
| 7 | Does the procedure address the calibration method and acceptance criteria? |
| 8 | Does the procedure address the frequency of calibration, and when the calibration interval begins? |
| 9 | Does the procedure address documentation of the calibration measurements before adjustment and measurements after any adjustments during calibration? |
| 10 | Does the procedure address actions taken to prevent unintended use of TMMDE identified as out-of-calibration, beyond calibration interval, or not in-service? |
| 11 | Does the procedure address when the TMMDE is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the TMMDE and product, including maintaining records and evidence of notification to the customer if suspect product has been shipped? |
| 12 | Does the procedure address the use of third-party, proprietary, employee-owned, and customer-owned TMMDE? |
| 13 | Does the procedure address the maintenance? |
| 14 | Does the procedure address suitability for the planned monitoring and measurement activities? |
| 5.8.3 | Equipment |
| 1 | Are the TMMDE are calibrated? |
| 2 | Are the TMMDE calibration status identifiable by the user prior to and during use? |
| 3 | Have the TMMDE safeguarded from adjustments or modifications that would invalidate the measurement result or the calibration status? |
| 4 | How are the TMMDE protected from damage and deterioration during handling, maintenance, and storage? |
| 5 | How does the organization ensure that TMMDE is used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests performed? |
| 6 | How does the organization ensure that when used in the testing, monitoring, measurement, or detection of specified requirements, the ability of computer software to satisfy the intended application are confirmed prior to initial use and reconfirmed, as necessary? |
| 5.8.4 | TMMDE Equipment from Other Sources |
| 1 | When TMMDE is third-party, proprietary, or customer-owned, how does the organization confirm the equipment is in calibration prior to use? (When limited by customer, contract, or licensing agreement, the requirements of 5.8.2, Item c), 5.8.2, Item d), 5.8.2, Item e), 5.8.2, Item f), 5.8.2, Item j), and 5.8.2, Item k) shall not apply.) |
| 5.8.5 | Records |
| 1 | Has the organization maintained a registry of the identified TMMDE that includes a unique identification, specific to each piece of equipment? |
| 2 | Are the Results of calibration recorded and maintained? |
| 3 | When calibration of the third-party, proprietary, and customer TMMDE to the requirements of 5.8 is limited by customer, contract, or licensing agreement, do the organization maintain records of the limitations imposed? |
| 5.9 | Control of Nonconforming Product |
| 5.9.1 | Procedure |
| 5.9.1.1 | General |
| 1 | Does the organization maintain a documented procedure addressing the controls and related responsibilities and authorities for nonconforming products during product realization and after delivery? |
| 5.9.1.2 | Nonconforming Product During Product Realization |
| 2 | For addressing nonconforming products identified during product realization, does the procedure include product identification and controls to prevent unintended use or delivery? |
| 3 | How does it address the detected nonconformity? |
| 4 | How does it address taking action to preclude its original intended use or delivery? |
| 5 | How does it address authorizing its use, release, or acceptance under concession by the relevant authority and, where applicable, by the customer? |
| 5.9.1.3 | Nonconforming Product After Delivery |
| 1 | How does the procedure address identifying, documenting, and reporting nonconforming products? |
| 2 | Does the procedure include the analysis of nonconforming product, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause? |
| 3 | How does the procedure address taking action appropriate to the effects, or potential effects, of the nonconformity? |
| 4 | Does the procedure include authorizing its use or acceptance under concession by relevant authority and, when required, by the customer? |
| 5.9.2 | Nonconforming Product |
| Does the organization address nonconforming products by performing one or more of the following: a) repair or rework with the subsequent inspection to meet specified requirements; b) re-grade for alternative applications; c) release under concession d) reject or scrap | |
| 5.9.3 | Release of Nonconforming Product Under Concession |
| 1 | For the nonconforming product that does not satisfy manufacturing acceptance criteria (MAC), how does the organization ensure that its release under concession meets one of the following conditions: a) products continue to satisfy the applicable Design Acceptance criteria (DAC) and/or customer criteria; or b) the violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer criteria; or c) the DAC is changed and the products satisfy the revised DAC and associated MAC requirements. When the DAC was previously agreed with the customer, the DAC change shall be authorized by the customer. |
| 2 | How does the organization ensure that the product not conforming to DAC or contract requirements is not released without customer authorization? |
| 5.9.4 | Customer Notification of Nonconforming Product |
| 1 | How does the organization notify customers of a product not conforming to DAC or contract requirements, that has been delivered? |
| 2 | Are records of such notification maintained? |
| 5.9.5 | Records |
| 1 | Are Records of nonconformities maintained? |
| 2 | Does the Records of nonconformities include the description of the nonconformity, subsequent actions taken, including concessions obtained, the rationale to support the release of the product under concession, and relevant authority? |
| 5.10 | Management of Change (MOC) |
| 5.10.1 | General |
| 1 | Do the organization maintain a documented procedure for MOC to maintain the integrity of the quality management system when changes occur? |
| 2 | Does the MOC procedure address the description of, and the need for, the change? |
| 3 | Does the MOC procedure address the availability and allocation of resources (including personnel)? |
| 4 | Does the MOC procedure address potential risks that may arise from implementing the change? |
| 5 | Does the MOC procedure address the review, approval, and implementation of the change? |
| 6 | Does the MOC procedure address notifications? |
| 7 | Does the MOC procedure address verification of the completion of MOC activities and impact on the QMS? |
| 5.10.2 | MOC Application |
| 1 | How does the organization use MOC for changes that may negatively impact the quality of the product? |
| 5.10.3 | MOC Notification |
| 1 | Does the organization notify relevant internal personnel of the change and associated risk? |
| 2 | When required by contract, does the organization notify the customer of the change and associated risk? |
| 3 | Are the MOC Notifications documented? |
| 5.10.4 | Records |
| 1 | Are the Records of MOC activities shall be maintained? |
| 6.0 | Quality Management System Monitoring, Measurement, Analysis, and Improvement |
| 6.1 | General |
| 1 | Have the organization planned and implemented the monitoring, measurement, analysis, and improvement processes needed to ensure conformity of the quality management system to the requirements of API Q1 specification and to continually improve the effectiveness of the quality management system? |
| 2 | Does the Quality management system monitoring, measurement, analysis, and improvement include the determination of applicable methods, including techniques for the analysis of data, and the extent of their use? |
| 6.2 | Monitoring, Measuring, and Improving |
| 6.2.1 | Customer Satisfaction |
| 1 | Does the organization maintain a documented procedure to measure customer satisfaction? |
| 2 | Does the procedure address the frequency and method of determining Customer satisfaction? |
| 3 | Does the procedure address the key performance indicators of customer satisfaction? |
| 4 | Are the records of the results of customer satisfaction information maintained? |
| 6.2.2 | Internal Audit |
| 6.2.2.1 | General |
| 1 | Does the organization conduct internal audits to ascertain whether the quality management system is implemented, maintained, and adheres to the specifications outlined in API Q1 as well as the organization’s quality management system requirements? |
| 2 | Does the organization maintain a documented procedure to define responsibilities for planning, conducting, and documenting internal audits? |
| 3 | Has the organization identified the audit criteria, scope, frequency, and methods of the internal audit? |
| 4 | Is the planning of audits conducted with consideration given to the outcomes of previous audits (both internal and external), the criticality of the audited process, and any modifications made to the quality management system? |
| 5 | Does the organization ensure that all processes of the quality management system claiming conformity to the requirements of API Q1 specification are audited at least every 12 months? |
| 6 | Is the time between audits of each part of the quality management system ensured not to exceed 12 months when the entire quality management system is not audited as one consolidated audit? |
| 7 | Do audits for processes performed by the organization, which are identified as critical to product realization, involve observing the activity being conducted and assessing whether it complies with the specified requirements? |
| 6.2.2.2 | Performance of Internal Audit |
| 1 | Are the Audits performed by competent personnel independent of those who performed or directly supervised the activity being audited to ensure objectivity and impartiality of the audit process? |
| 2 | Are records of Internal audits maintained? |
| 3 | Do the records provide objective evidence that the quality management system is implemented and maintained? |
| 6.2.2.3 | Audit Review and Closure |
| 1 | How does the organization identify response times for addressing detected nonconformities? |
| 2 | How does the management responsible for the area being audited ensure that necessary corrections and corrective actions are undertaken as per requirements for corrective action? |
| 3 | Are the Records of internal audits maintained? |
| 6.3 | Analysis of Data |
| 1 | Does the organization maintain a documented procedure for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system? |
| 2 | Does the analysis include data generated from monitoring and measurement, internal audits, audits by external parties, management reviews, and other relevant sources? |
| 3 | Does the data analysis output provide information relating to customer satisfaction, nonconformity to product requirements during product realization, process performance, supplier performance and achiving quality objectives? |
| 4 | Does it include the nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause? |
| 5 | Does the organization use data to evaluate where continual improvement of the effectiveness of the quality management system can be made? |
| 6.4 | Improvement |
| 6.4.1 | General |
| 1 | Does the organization continually improve the effectiveness of the quality management system by evaluating, selecting, and implementing opportunities for improvement through quality objectives, internal audit, data analysis, corrective action, and management review. ? |
| 6.4.2 | Corrective Action |
| 1 | Does the organization maintain a documented procedure to handle nonconformities, including those arising from customer complaints, and to initiate corrective actions both internally and with suppliers? |
| 2 | Are the Corrective actions appropriate to the effect(s) of the nonconformity encountered? |
| 3 | Does the procedure address the criteria for determining when the corrective action process is initiated? |
| 4 | Does the procedure address reviewing the nonconformity? |
| 5 | Does the procedure address determining and implementing corrections? |
| 6 | Does the procedure address identifying the root cause of the nonconformity and evaluating the need for corrective actions? |
| 7 | Does the procedure address the implementing corrective action to reduce the likelihood that a nonconformity recurs? |
| 8 | Does the procedure address identifying the timeframe and responsible person(s) for addressing corrections and corrective action? |
| 9 | Does the procedure address the verification of the effectiveness of the corrections and corrective action taken? |
| 10 | Does the procedure address the updating risks and opportunities determined during planning? |
| 11 | Does the procedure address the MOC when the corrective actions require new or changed controls within the quality management system? |
| 12 | Does the procedure address evaluating similar, potential nonconformities and implementing action to reduce the likelihood of occurrence, as appropriate? |
| 13 | Are the Records of corrective action process activities maintained? |
| 14 | Do the Records identify the activities performed to verify the effectiveness of the corrective actions taken? |
| 6.5 | Management Review |
| 6.5.1 | General |
| 1 | Is the organization‘s quality management system reviewed at least every 12 months(not later than the end of the same calendar month as the prior year review) by the organization’s management? |
| 2 | Does the management review evaluate the quality management system’s continuing suitability, adequacy, and effectiveness? |
| 3 | Do the reviews include assessing opportunities for improvement, adequacy of resources and the need for changes to the quality management system, including the quality policy and quality objectives? |
| 6.5.2 | Input Requirements |
| 1 | Does the input to the management review include the status and effectiveness of actions resulting from previous management reviews? |
| 2 | Does the input to management review include the results of audits and audits of the organization by external parties? |
| 3 | Does the input to management review include changes that could affect the quality management system, including changes to legal and other applicable requirements(such as industry standards)? |
| 4 | Does the input to management review include changes that could affect the quality management system, including changes in external and internal issues that are relevant to the quality management system? |
| 5 | Does the input to the management review include an analysis of customer satisfaction? |
| 6 | Does the input to the management review include relevant feedback from customers and other interested parties? |
| 7 | Does the input to management review include process performance? |
| 8 | Does the input to the management review include the results of the risk assessment and the effectiveness of actions taken to address risks? |
| 7 | Does the input to management review include the status of corrective actions? |
| 8 | Does the input to the management review include the analysis of supplier performance? |
| 9 | Does the input to management review include a review of the analysis of product conformity, including nonconformities identified after delivery or use? |
| 10 | Does the input to the management review include actual performance compared with quality objectives? |
| 11 | Does the input to the management review include recommendations for improvement? |
| 6.5.3 | Output Requirements |
| 1 | Does the output from the management review include a summary assessment of the effectiveness of the quality management system? |
| 2 | Does the assessment include any required changes to the processes and any decisions and actions, required resources, and any improvement to products in meeting customer requirements? |
| 3 | Do the Top management reviews and approves the output of management reviews? |
| 4 | Has the organization applied the API Monogram to products developed, maintained, and operated at all times in a quality management system conforming to API Q1? |
| 5 | Are the records of the management review maintained? |
| Use of API Monogram by Licensees | |
| A.4 | Quality Management System Requirements |
| 1 | Has the organization applied the API Monogram to products developed, maintained, and operated at all times in a quality management system conforming to API Q1? |
| A.5 | Control of the Application and Removal of the API Monogram |
| 1 | Does the Licensee ensure that Products that do not conform to API-specified requirements shall not bear the API Monogram |
| 2 | Has the Licensee developed and maintained an API Monogram marking procedure that documents the marking/monogramming requirements and any applicable API product specification(s) and/or standard(s)? |
| 3 | Has the organization applied the API Monogram to products developed, maintained, and operated at all times a quality management system conforming to API Q1. |
| 4 | Does the marking procedure define the method(s) used to apply the Monogram? |
| 5 | Does the marking procedure identify the location on the product where the API Monogram is to be applied? |
| 6 | Does the marking procedure require the application of the Licensee’s license number and date of manufacture of the product in conjunction with the use of the API Monogram? |
| 7 | Does the marking procedure require that the date of manufacture, at a minimum, be two digits representing the month and two digits representing the year (e.g. 05-12 for May 2012) unless otherwise stipulated in the applicable API product specification(s) or standard(s)? |
| 8 | Does the marking procedure require controls for the application of the additional API product specification(s) and/or standard(s) marking requirements, as applicable? |
| 9 | Is the API Monogram removed by the Licensee’s API Monogram marking procedure if the product is subsequently found to be out of conformance with any of the requirements of the applicable API product specification(s) and/or standard(s) and API Monogram Program? |
| 10 | Is the API monogram applied at the site for which the API Monogram license is issued? |
| 11 | Is the API Monogram removed in accordance with the Licensee’s API Monogram marking procedure if the product is subsequently found to be out of conformance with any of the requirements of the applicable API product specification(s) and/or standard(s) and API Monogram Program? |
| A.6 | Design Package Requirements |
| 1 | Does the Licensee and/or applicant for licensing maintain a current design package for all of the applicable products that fall under the scope of each Monogram license? |
| 2 | Does the design package information provide objective evidence that the product design meets the requirements of the applicable and most current API product specification(s)? |
| 3 | Is the design package(s) made available during API audits of the facility? |
| A.7 | Manufacturing Capability |
| 1 | Has facilities demonstrated the ability to manufacture equipment that conforms to API specifications and/or standards? |
| A.8 | API Monogram Program: Nonconformance Reporting |
| 1 | As a customer do you report to API all problems with API monogrammed products using the API Nonconformance Reporting System available at http://compositelist.api.org/ncr.asp. |
