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 | |
| 1.0 | Scope |
| Has the organization claimed exclusion for any of the following sections 5.4 Design and Development; 5.7.1.2, Servicing; 5.7.1.5, Validation of Processes for Production and Servicing; 5.7.5, Customer-supplied Property; 5.8, Control of Testing, Measuring, and Monitoring Equipment. | |
| Where exclusions are made, is the basis for claiming exclusions identified? | |
| Does such exclusions affects the organization’s ability, or responsibility, to provide products and related servicing that meet customer and applicable regulatory requirements? | |
| 4.0 | Quality Management System Requirements |
| 4.1 | Quality Management System |
| 4.1.1 | General |
| 1 | Has the organization established , documented and implemented a Quality Management System for all products and servicing provided for use in the petroleum and natural gas industry? |
| 2 | How does the organization maintains the Quality Management system at all times? |
| 3 | How does the organization measure the effectiveness the quality management system in accordance with the requirements of API Specification Q1? |
| 4 | How does the organization improve upon the quality management system in accordance with 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 | Has the quality policy been defined, documented, and approved by top management? |
| 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 ensures that Quality policy is the basis for the development of quality objectives? |
| 6 | How does the organization ensures that Quality policy is communicated, understood, implemented, and maintained at all relevant functions and levels within the organization? |
| 7 | Does the policy includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system. |
| 4.1.3 | Quality Objectives |
| 1 | How does the management ensures that quality objectives, including those needed to meet product and customer requirements, are established at relevant functions and levels within the organization? |
| 2 | Is the Quality objectives approved from top management? |
| 3 | Is the Quality objectives measurable? |
| 4 | Is the Quality objectives consistent with the quality policy |
| 4.1.4 | Planning |
| How does the management determine the criteria and methods needed for the operation and control of all quality management system processes? | |
| How does the management effectively management the criteria and methods needed for the operation and control of all quality management system processes? | |
| How does the management ensures the planning of the quality management system is carried out in order to meet the requirements of API Specification Q1? | |
| 4.1.5 | Communication |
| 4.1.5.1 | Internal |
| 1 | How does the management ensures that appropriate communication processes are established within the organization? |
| 2 | How does the management ensures that and the effectiveness of the quality management system is communicated? |
| 3 | How does the organization establishes processes to ensure that the importance of meeting customer, legal, and other applicable requirements is communicated at relevant functions within the organization? |
| 4 | How does the organization establishes 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 | How does the organization determine and implement the process for communicating with external organizations, including customers, to ensure requirements are understood throughout contract execution and product realization? |
| 2 | How does the communication process addresses execution of inquiries, contracts, or order handling and amendments? |
| 3 | How does the communication process addresses provision of product information, including product nonconformities identified after delivery to the customer? |
| 4 | How does the communication process addresses feedback and customer complaints? |
| 5 | When required by contract how does the organization provide information required by product quality plans and subsequent changes to those plans? |
| 4.2 | Management Responsibility |
| 4.2.1 | General |
| 1 | How does the top management ensures the availability of resources essential to establish, implement, maintain, and improve the quality management system? Does it includes human resources and specialized skills, organizational infrastructure, financial resources, and technology? |
| 2 | How does the management ensures that quality objectives are established including key performance indicators for use in data analysis? |
| 3 | Does the management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improve its effectiveness by establishing quality objectives and conducting management reviews? |
| 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 a Management Representative? |
| 2 | How does the Management Representative ensure that processes needed for the quality management system are established, implemented, and maintained? |
| 3 | How does the Management Representative report to top management on the performance of the quality management system and any need for improvement? |
| 4 | How does the Management Representative ensure initiation of action(s) to minimize the likelihood of the occurrence of nonconformities? |
| 5 | How does the Management Representative ensure the promotion of awareness of customer requirements throughout the organization |
| 4.3 | Organization Capability |
| 4.3.1 | Provision of Resources |
| 1 | How does the organization determines and allocates the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system? |
| 4.3.2 | Human Resources |
| 4.3.2.1 | General |
| 1 | Does the organization maintains a documented procedure for defining personnel competency and identifying training requirements or other actions to achieve the necessary competency of personnel whose responsibilities fall within the scope of the quality management system? |
| 2 | Does the procedure includes provisions for determining and documenting the effectiveness of the training or other actions taken toward the achievement of required competency? |
| 4.3.2.2 | Personnel Competence |
| 1 | How does the organization ensure that Personnel are competent based on the appropriate education, training, skills, and experience needed to meet product and customer requirements? |
| 2 | Are the records of evidence of the determination of competence of personnel maintained? |
| 4.3.2.3 | Training and Awareness |
| 1 | Does the organization provide for quality management system training and job training? |
| 2 | Does the organization ensure that customer-specified training and/or customer-provided training, when required, is included in the training program? |
| 3 | Does the organization ensure that the frequency and content of training is identified? |
| 4 | Does the organization ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives? |
| 5 | Does the organization maintain appropriate records of education, training, skills, and experience? |
| 4.3.3 | Work Environment |
| 1 | How does the organization determine, provide, manage, and maintain the work environment needed to achieve conformity applicable to the manufacture of the product? |
| 2 | Does work environment include a) buildings, workspace, and associated utilities; b) process equipment and its maintenance (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 includes statements of quality policy and quality objectives? |
| 2 | Does the quality management system documentation includes a quality manual that addresses each requirement of API Specification Q1? |
| 3 | Does the quality manual includes the scope of the quality management system, including justification for any exclusions to specific quality management system elements? |
| 4 | Does the quality manual includes a description of the sequence and interaction between the processes of the quality management system? |
| 5 | Does the quality manual includes identification of processes that require validation? |
| 6 | Does the quality manual includes reference to documented procedures that control the quality management system processes? |
| 7 | Does the quality management system documentation includes documented procedures established for the quality management system? |
| 8 | Does the quality management system documentation includes documents and records to ensure the effective planning, operation, and control of its processes and compliance with specified requirements? |
| 9 | Does the quality management system documentation includes identification of legal and other applicable requirements to which the organization claims compliance that are needed to achieve product conformity? |
| 4.4.2 | Procedures |
| Are all procedures referenced within API Specification Q1 established, documented, implemented, and maintained for continued suitability? | |
| 4.4.3 | Control of Documents |
| 1 | Does the organization maintains a documented procedure for the identification, distribution, and control of documents required by the quality management system and API Specification Q1, including required documents of an origin external to the organization? |
| 2 | Does the procedure specifies responsibilities for approval and re-approval? |
| 3 | Does the procedure identify the controls needed to ensure that the documents required by the quality management system, including its revisions, translations, and updates a) are reviewed and approved for adequacy prior to issue and use, b) identify changes and revision status, c) remain legible and readily identifiable, and d) are available where the activity is being performed. |
| 4 | How are Documents of external origin controlled to ensure that the relevant versions are used and maintained? |
| 6 | How 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? |
| 7 | How are Procedures, work instructions, forms required by the quality management system controlled? |
| 4.4.4 | Use of External Documents in Product Realization |
| 1 | When API product or external specification requirements, including addenda, errata, and updates, are used in the design or manufacture of the product, does the organization maintains a documented procedure for the integration of these requirements into the product realization process and any other affected processes? |
| 4.5 | Control of Records |
| 1 | Does the organization maintains a documented procedure to identify the controls and responsibilities needed for the identification, collection, storage, protection, retrieval, retention time, and disposition of records. |
| 2 | Are Records established and controlled to provide evidence of conformity to requirements and the organization’s quality management system? |
| 3 | Are Records established and controlled from those originating from outsourced activities? |
| 4 | Does the records remain legible, identifiable, and retrievable? |
| 5 | Are the records retained for a minimum of five years or as required by 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 and required servicing? |
| 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 reviews the requirements related to provision of products? |
| 2 | Is this review conducted prior to the organization‘s commitment to deliver product to the customer? |
| 3 | How does the organization ensures that requirements are identified and documented? |
| 4 | How does the organization ensures that requirements differing from those previously identified are resolved? |
| 5 | How does the organization ensures that the organization has the capability to meet the documented requirements? |
| 6 | Where contract requirements are changed, how does the organization ensures 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 | Is the planning of product realization shall be consistent with the requirements of the other processes of the quality management system? |
| 3 | 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 contingencies based on risk assessment? |
| 7 | How does the organization plan for the design and development 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 product 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 processes meet requirements? |
| 11 | Is the output of planning documented? |
| 12 | Is the output of planning updated as changes occur? |
| 13 | Is the plans maintained in a structure suitable for the organization‘s method of operations? |
| 5.3 | Risk Assessment and Management |
| 1 | Does the organization maintains a documented procedure to identify and control risk associated with impact on delivery and quality of product? |
| 2 | Does the procedure identifies the techniques, tools and their application for risk identification, assessment, and mitigation? Does it include consideration of severity, detection methods, and probability of occurrence? |
| 3 | Does Risk assessment associated with product delivery includes facility/equipment availability and maintenance? |
| 4 | Does Risk assessment associated with product delivery includes supplier performance and material availability/supply? |
| 5 | Does the Risk assessment associated with product quality includes delivery of nonconforming product? |
| 6 | Does the Risk assessment associated with product quality includes availability of competent personnel? |
| 7 | Is the Records of risk assessment and management including actions taken maintained? |
| 5.4 | Design and Development |
| 5.4.1 | Design and Development Planning |
| 1 | Does the organization maintains a documented procedure to plan and control the design and development of the product? |
| 2 | Does the procedure identifies the plans, including plan updates, used for design development? |
| 3 | Does the procedure identifies the design and development stages? |
| 4 | Does the procedure identifies the resources, responsibilities, authorities, and their interfaces to ensure effective communication? |
| 5 | Does the procedure identifies the review, verification, and validation activities necessary to complete each design and development stage? |
| 6 | Does the procedure identifies the requirements for a final review of the design? |
| 7 | When design and development activities are performed at different locations within the organization, does the procedure identifies the controls required to ensure that the designs meet the requirements of Design and Development? |
| 8 | When design and development are outsourced, how does the organization ensures the supplier meets the requirements of outsourcing? |
| 5.4.2 | Design and Development Inputs |
| 1 | How does the organization identifies and reviews the Inputs for adequacy, completeness, and lack of conflict? |
| 2 | Does the Inputs includes functional and technical requirements? |
| 3 | Does the Inputs includes customer-specified requirements? |
| 4 | Does the Inputs includes requirements provided from external sources, including API product specifications? |
| 5 | Does the Inputs includes environmental and operational conditions? |
| 6 | Does the Inputs includes methodology, assumptions, and formulae documentation? |
| 7 | Does the Inputs includes historical performance and other information derived from previous similar designs? |
| 8 | Does the Inputs includes legal requirements? |
| 9 | Does the Inputs includes results from risk assessments? |
| 10 | Are the records of design inputs maintained? |
| 5.4.3 | Design and Development Outputs |
| 1 | How does the organization document its output to allow verification against the design and development input requirements? |
| 2 | Does the output meet the input requirements for design and development? |
| 3 | Does the output provide appropriate information for purchasing, production, and servicing? |
| 4 | Does the output identifies or refer to the 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 includes results of applicable calculations? |
| 7 | Does the output specifies the characteristics of the product that are essential for its safe and proper use? |
| 8 | Are the Records of design outputs maintained? |
| 5.4.4 | Design and Development Review |
| 1 | Are Design and Development Review performed at suitable stages? |
| 2 | Are review performed to evaluate the suitability, adequacy, and effectiveness of the results of design and development stages to meet specified requirements? |
| 3 | Are review performed to identify any problems and propose necessary actions? |
| 4 | Are review performed by representatives of functions concerned with the design and development stage(s) being reviewed? |
| 5 | Are the records of the results of the review(s) and any necessary actions maintained? |
| 5.4.5 | Design and Development Verification and Final Review |
| 1 | To ensure that the design and development outputs have met the design and development input requirements, How does the organization ensures that design and development verification and a final review are conducted and documented in accordance with planned arrangements? |
| 2 | Are the records of design and development verification and the final review maintained? |
| 5.4.6 | Design and Development Validation and Approval |
| 1 | Are Design and development validation performed in accordance with planned arrangements? |
| 2 | How does the organization ensures that Design and development 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 ensures that completed design is approved after validation? |
| 5 | How does the organization ensures that Competent individual(s) other than the person or persons who developed the design approves the final design? |
| 6 | Are records of the design and development validation, approval, and any necessary actions maintained? |
| 5.4.7 | Design and Development Changes |
| 1 | How are Design and Development changes identified? |
| 2 | How does the organization ensures that the changes are reviewed, verified, and validated, as appropriate, and approved before implementation? |
| 3 | How does the organization ensures that the review of design and development changes includes evaluation of the effect of the changes on product and/or their constituent parts already delivered? |
| 4 | How does the organization ensures that the design and development changes, including changes to design documents, have the same controls as the original design and development? |
| 5 | Are the records of design and development changes, reviews of those changes, and any necessary actions maintained? |
| 5.5 | Contingency Planning |
| 5.5.1 | General |
| 1 | Does the organization maintains a documented procedure for contingency planning needed to address risk associated with impact on delivery and quality of product? |
| 2 | Is Contingency planning shall be based on assessed risks? |
| 3 | Are the output of Contingency planning documented and communicated to the relevant personnel? |
| 4 | Are the output of Contingency planning updated as required? |
| 5.5.2 | Planning Output |
| 1 | Does the contingency plan include actions required in response to significant risk scenarios to mitigate effects of disruptive incidents? |
| 2 | Does the contingency plan include identification and assignment of responsibilities and authorities? |
| Does the contingency plan include internal and external communication controls ? | |
| 5.6 | Purchasing |
| 5.6.1 | Purchasing Control |
| 5.6.1.1 | Procedure |
| 1 | Does the organization maintains a documented procedure to ensure that purchased products or outsourced activities conform to specified requirements? |
| 2 | Does the procedure determines the criticality of the activities or products as they are applicable to conformance to product or customer specifications? |
| 3 | Does the procedure address initial evaluation and selection of suppliers based on their ability to supply products or activities in accordance with the organization‘s requirements? |
| 4 | Does the procedure address type and extent of control applied to the supplier based on the criticality of the product or activity? |
| 5 | Does the procedure address criteria, scope, frequency, and methods for reassessment of suppliers? |
| 6 | Does the procedure address maintaining a list of approved suppliers and scope of approval |
| 7 | Does the procedure address type and extent of control to be applied to outsourced activities? |
| 5.6.1.2 | Initial Supplier Evaluation—Critical Purchases |
| 1 | For purchase of critical products, components or activities , is the criteria for the initial evaluation of suppliers by the organization site-specific for each supplier ? |
| 2 | Does the initial Supplier Evaluation for Critical Purchases includes the verification that the supplier’s quality management system conforms to the quality system requirements specified for suppliers by the organization? |
| 3 | Does the initial Supplier Evaluation for Critical Purchases includes the assessment of the supplier to ensure its capability to meet the organization’s purchasing requirements? |
| 4 | Does the initial Supplier Evaluation for Critical Purchases includes performing an on-site evaluation of relevant activities? |
| 5 | Does the initial Supplier Evaluation for Critical Purchases includes performing first article inspection to ensure conformance to stated requirements? |
| 6 | Does the initial Supplier Evaluation for Critical Purchases includes identifying how the supplied product conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements? |
| 5.6.1.3 | Initial Supplier Evaluation—Noncritical Purchases |
| 1 | For purchase of noncritical products, components, or activities that impact product realization or the final product, does the criteria for evaluation of suppliers by the organization meets the requirements as that of initial Supplier Evaluation for Critical Purchases or satisfy the 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 |
| 5.6.1.4 | Supplier Reevaluation |
| 1 | For reevaluation of all suppliers (critical and noncritical), does the requirements of Initial Supplier Evaluation for Noncritical Purchases apply? |
| 5.6.1.5 | Supplier Evaluation—Records |
| 1 | Are the Records of the results of all evaluations and any necessary actions arising from the evaluations maintained? |
| 5.6.1.6 | Outsourcing |
| 1 | Where an organization chooses to outsource any activity within the scope of its quality management system, how does the organization ensures that all applicable elements of its quality management system are satisfied? |
| 2 | How does the organization maintains responsibility for product conformance to specified requirements, including applicable API product specifications, associated with product realization? |
| Are the Records of outsourced activities maintained? | |
| 5.6.2 | Purchasing Information |
| 1 | How does the organization ensures the adequacy of specified purchasing information prior to their communication to the supplier? |
| 2 | Does the Purchasing information provided to the supplier documented and adequately describe the product or activity to be purchased, including acceptance criteria? |
| 3 | Does the Purchasing information describes requirements for approval of supplier’s procedures, processes, and equipment? |
| 4 | Does the Purchasing information describes applicable version of specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data? |
| 5 | Does the Purchasing information describes requirements for qualification of supplier’s personnel? |
| 6 | Does the Purchasing information describes quality management system requirements? |
| 5.6.3 | Verification of Purchased Products or Activities |
| 1 | Does the organization maintains a documented procedure for the verification or other activities necessary for ensuring that purchased products or activities meet specified purchase requirements? |
| 2 | Where the organization or its customer intends to perform verification at the supplier‘s premises, does the organization states the intended verification arrangements and method of product release in the purchasing information? |
| 3 | How does the organization ensures and provides evidence that purchased products and activities conform to specified requirements? |
| 4 | Are the Records of verification activities maintained? |
| 5.7 | Production and Servicing Provision |
| 5.7.1 | Control of Production and Servicing |
| 5.7.1.1 | Production |
| 1 | Does the organization maintains a documented procedure that describes controls associated with the production of products? |
| 2 | Does the procedure address the availability of information that describes the characteristics of the product? |
| 3 | Does the procedure address implementation of the product quality plan, when applicable? |
| 4 | Does the procedure address ensuring design requirements and related changes are satisfied, when applicable? |
| 5 | Does the procedure address the availability and use of suitable production, testing, monitoring, and measurement equipment? |
| 6 | Does the procedure address the availability of work instructions, when applicable? |
| 7 | Does the procedure address process control documents? |
| 8 | Does the procedure address implementation of monitoring and measurement activities? |
| 9 | Does the procedure address implementation of product release including applicable delivery and post-delivery activities? |
| 5.7.1.2 | Servicing |
| 1 | Does the organization maintains a documented procedure that describes controls associated with the servicing of products? |
| 2 | Does the procedure address review and implementation of the organization’s, customer-specific, product servicing, and other servicing requirements? |
| 3 | Does the procedure address the availability and use of suitable servicing, testing, monitoring, and measurement equipment? |
| 4 | Does the procedure address the availability of work instructions, when applicable? |
| 5 | Does the procedure address ensuring identification and traceability requirements are maintained throughout the servicing process? |
| 6 | Does the procedure address the implementation of monitoring and measurement activities? |
| 7 | Does the procedure address process control documents? |
| 8 | Does the procedure address requirements for release of the product that was serviced? |
| 5.7.1.3 | Process Control Documents |
| 1 | Are process controls shall be documented in routing, travelers, checklists, process sheets, or equivalent controls required by the organization? |
| 2 | Does Process control documents includes shall include requirements for verifying conformance with applicable product quality plans , API product specifications, customer requirements, and/or other applicable product standards/codes? |
| 3 | Does Process control documents includes or reference instructions and acceptance criteria for processes, tests, inspections, and required customer’s inspection hold or witness points? |
| 5.7.1.4 | Product Realization Capability Documentation |
| 1 | Does the organization maintains a documented procedure that includes product realization plans? |
| 2 | Does the organization maintains a documented procedure that includes records of review/verification, validation, monitoring, measurement, inspection, and test activities, including criteria for product acceptance that demonstrates the capability of the organization to satisfy specified product and/or servicing requirements? |
| 5.7.1.5 | Validation of Processes for Production and Servicing |
| 1 | How does the organization validates the processes for production and servicing where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the servicing has been delivered? |
| 2 | How do you ensure that validation demonstrates the ability of processes to achieve planned results? |
| 3 | When an organization chooses to outsource a process that requires validation,how does the organization ensures that the supplier conform to requirements of outsourcing |
| 4 | Does the organization maintains a documented procedure to address methods for review and approval of the processes that includes a) required equipment; b) qualification of personnel; c) use of specific methods, including identified operating parameters; d) identification of acceptance criteria; e) requirements for records f) revalidation. |
| 5 | Does the organization validates those processes identified by the applicable product specification as requiring validation? |
| 6 | If applicable to the products, does the organization validates the following process that is nondestructive examination, welding, and heat treating? |
| 5.7.2 | Product Quality Plans |
| 1 | When required by contract, does the organization has developed a product 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 Product Quality plan addresses the description of the product to be manufactured? |
| 3 | Does the Product Quality plan addresses the required processes and documentation, including required inspections, tests, and records, for conformance with requirements? |
| 4 | Does the Product Quality plan addresses the identification and reference to control of outsourced activities? |
| 5 | Does the Product Quality plan addresses the identification of each procedure, specification, or other document referenced or used in each activity? |
| 6 | Does the Product Quality plan addresses the identification of the required hold, witness, monitor, and document review points? |
| 7 | Are the product quality plans and any revisions to them documented and approved by the organization to ensure customer requirements are met? |
| 8 | Are the product quality plans and any revisions communicated to the customer? |
| 5.7.3 | Identification and Traceability |
| 1 | Does the organization maintains a documented procedure for identification and traceability while the product is under control of the organization as required by the organization, the customer, and/or the applicable product specifications throughout the product realization process, including applicable delivery and post-delivery activities? |
| 2 | Does it includes requirements for maintenance or replacement of identification and/or traceability marks? |
| 3 | Are the Records of identification and traceability shall be maintained? |
| 5.7.4 | Product Inspection/Test Status |
| 1 | Does the organization maintains a documented procedure for the identification of product inspection and/or test status throughout the product realization process that indicates the conformity or nonconformity of product with respect to inspections and/or tests performed? |
| 2 | How does the organization ensures that that only product that meets requirements or that is authorized under concession is released? |
| 5.7.5 | Customer-supplied Property |
| 1 | Does the organization maintains a documented procedure for the identification, verification, safeguarding, preservation, maintenance, and control of customer-supplied property, including intellectual property and data, while under control of the organization? |
| 2 | Does the procedure includes requirements for reporting to the customer any loss, damage, or unsuitability for use of customer-supplied property? |
| 3 | Are the records for the control and disposition of customer-supplied property maintained? |
| 5.7.6 | Preservation of Product |
| 5.7.6.1 | General |
| 1 | Does the organization maintains a documented procedure for describing the methods used to preserve the product and constituent parts throughout product realization and delivery to the intended destination in order to maintain conformity to requirements? |
| 2 | Does it includes identification and traceability marks, transportation, handling, packaging, and protection? |
| 5.7.6.2 | Storage and Assessment |
| 1 | Does the procedure for preservation of product identify the requirements for storage and assessment? |
| 2 | Does the organization uses designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery? |
| 3 | Does the procedure identifies to intervals to assess the condition of product or constituent parts in stock order to detect deterioration? |
| 4 | It the interval appropriate to the products or constituent parts being assessed? |
| 5 | Are the records of the results of assessments maintained? |
| 5.7.7 | Inspection and Testing |
| 5.7.7.1 | General |
| 1 | Does the organization maintains a documented procedure for inspection and testing to verify that product requirements have been met? |
| 2 | Does the procedure includes requirements for in-process and final inspection and testing? |
| 3 | Are the records of inspection and testing maintained? |
| 5.7.7.2 | In-process Inspection and Testing |
| 1 | Are the In-process Inspection and Testing of the products are conducted at planned stages as required by the product quality plan, process control documents, and/or documented procedures |
| 2 | Are the evidence of conformity with the acceptance criteria maintained? |
| 5.7.7.3 | Final Inspection and Testing |
| 1 | Are the Final Inspection and Testing of the products are conducted as required by the product quality plan, and/or documented procedures? |
| 2 | Does it validate and document conformity of the finished product to the specified requirements? |
| 3 | Is the final acceptance inspection at planned stages of the product realization process performed by personnel other then those who performed or directly supervised the production of the product? |
| 5.7.8 | Preventive Maintenance |
| 1 | Does the organization maintains a documented procedure for the establishment of preventive maintenance for equipment used in product realization? |
| 2 | Does the procedure identifies 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? |
| 5.8 | Control of Testing, Measuring, and Monitoring Equipment |
| 1 | How does the organization determines the testing, monitoring, and measurement requirements and the associated equipment needed to provide evidence of conformity to those requirements? |
| 2 | Does the organization maintains a documented procedure in order to ensure that testing, measurement, and monitoring equipment is calibrated and maintained? |
| 3 | How does the organization ensures that the equipment is used in a manner that is consistent with monitoring and measurement requirements |
| 4 | Does the procedure includes requirements for the specific equipment type that addresses unique identifier, calibration status, acceptance criteria and frequency of calibration, at specific intervals or prior to use? |
| 5 | Does the procedure includes equipment traceability to international or national measurement standards and where no such standards exist, the basis used for calibration or verification shall be recorded? |
| 6 | Does the procedure includes calibration or verification method, including adjustments and readjustments, as necessary? |
| 7 | Does the procedure includes the control of equipment identified as out-of-calibration in order to prevent unintended use? |
| 8 | When the equipment is found to be out of calibration, how is the assessment done on the validity of previous measurements? |
| 9 | When the equipment is found to be out of calibration what actions are taken on the equipment and product? |
| 10 | Are records being maintained on the assessment done and action taken? |
| 11 | Are there evidence of notification to the customer if suspect product has been shipped? |
| 12 | Are Testing, measuring, and monitoring equipment being calibrated or verified, or both, against measurement standards? |
| 13 | Are the calibration status of the testing, measuring, and monitoring equipment identifiable by the user for the activities being performed at all times? |
| 14 | Are Testing, measuring, and monitoring equipment safeguarded from adjustments that would invalidate the measurement result or the calibration status? |
| 15 | Are Testing, measuring, and monitoring equipment protected from damage and deterioration during handling, maintenance, and storage? |
| 16 | Are Testing, measuring, and monitoring equipment used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests being carried out? |
| 17 | When used in the testing, monitoring, or measurement of specified requirements, how does the organization confirm the ability of computer software to satisfy the intended application prior to initial use and reconfirmed as necessary? |
| 18 | When the equipment is provided from a source external to the organization, including third-party, proprietary, employee- and customer-owned equipment, how does the organization verify that the equipment is suitable to the requirements of Control of Testing, Measuring, and Monitoring Equipment? |
| 19 | How does the organization provide evidence of conformity? |
| 20 | Are the Records of the results of calibration and verification maintained? |
| 5.9 | Product Release |
| 1 | Does the organization maintains a documented procedure for product release? |
| 2 | How does the organization ensures that the release of product to the customer does not proceed until all the planned arrangements have been satisfactorily completed, or unless otherwise approved by a relevant authority and, where applicable, by the customer? |
| 3 | Are Records to enable identification of the individual releasing the product maintained? |
| 5.10 | Control of Nonconforming Product |
| 5.10.1 | General |
| 1 | Does the organization maintains a documented procedure to identify the controls and related responsibilities and authorities for addressing nonconforming product? |
| 2 | For addressing nonconforming product identified during product realization, does the procedure includes the controls for product identification 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 relevant authority and, where applicable, by the customer? |
| 6 | How does the procedure address identifying, documenting, and reporting nonconformances or product failure identified after delivery? |
| 7 | How does the procedure address taking action appropriate to the effects, or potential effects, of the nonconformance when nonconforming product is detected after delivery? |
| 8 | How does the organization ensure the analysis of product nonconformance or failure, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause? |
| 5.10.2 | Nonconforming Product |
| Does the organization addresses nonconforming product by performing one or more of the following: a) repair or rework with subsequent inspection to meet specified requirements; b) re-grade for alternative applications; c) release under concession d) reject or scrap | |
| 5.10.3 | Release of Nonconforming Product Under Concession |
| 1 | For the nonconforming product that does not satisfy manufacturing acceptance criteria (MAC), how does the organization ensures that its release under concession meet the one of the following condition: 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 are changed and the products satisfy the revised DAC and associated MAC requirements |
| 2 | How does the organization ensures that the organization’s relevant authority and the customer (where applicable) have authorized the release? |
| 5.10.4 | Customer Notification |
| 1 | How does the organization notifies customers of product not conforming to DAC or contract requirements, that has been delivered? |
| 2 | Are records of such notification maintained? |
| 5.11 | Management of Change (MOC) |
| 5.11.1 | General |
| 1 | What is the process of MOC of the organization? |
| 2 | How does the organization ensures that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented? |
| 3 | For MOC, does the organization identifies the potential risks associated with the change ? |
| 4 | What approvals are required prior to the introduction of such changes? |
| 5 | Are records of MOC activities maintained? |
| 5.11.2 | MOC Implementation |
| Are the process of MOC implemented for changes in the organizational structure? | |
| Are the process of MOC implemented for changes in key or essential personnel? | |
| Are the process of MOC implemented for changes in critical suppliers? | |
| Are the process of MOC implemented for changes to the management system procedures, including changes resulting from corrective and preventive actions? | |
| 5.11.3 | MOC Notification |
| For the changes that have either been initiated by the organization or requested by the customer, how does the organization notify relevant personnel, including the customer when required by contract, of the change and residual or new risk due to changes? | |
| 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 includes 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 maintains a documented procedure to measure customer satisfaction? |
| 2 | Does the procedure addresses the frequency of measurement, obtaining customer feedback, key performance indicators (KPIs), and other information that the organization uses to determine whether the organization has satisfied customers in meeting identified requirements? |
| 3 | 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 maintains a documented procedure to define responsibilities for planning, conducting, and documenting internal audits? |
| 2 | Does the Audits verifies that the quality management system is effectively implemented and maintained and conforms to the requirements of API Q1 specification? |
| 3 | Does the planning of internal audits take into consideration the results of previous audits and criticality of the process being audited? |
| 4 | Has the organization identified the audit criteria, scope, frequency, and methods of the internal audit? |
| 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 | Does the organization ensure that outsourced activities that impact the quality of the product and that are performed at the organization’s facility shall be included as part of the internal audit of the organization? |
| 6.2.2.2 | Performance of Internal Audit |
| 1 | Are the Audits shall be 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 audit maintained? |
| 3 | Do the records provide objective evidence that the quality management system is implemented and maintained? |
| 4 | Are all processes of the quality management system required to meet API Q1 specification audited prior to claiming conformance to the requirements of this specification? |
| 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 results of internal audits and the status of corrective actions reported in the management review? |
| Are the Records of internal audits maintained? | |
| 6.2.3 | Process Evaluation |
| 1 | Has the organization applied suitable evaluation methods to demonstrate the ability of the quality management system processes to achieve planned results, including conformity to product requirements? |
| 2 | Are correction and corrective action taken when planned results are not achieved? |
| 6.3 | Analysis of Data |
| 1 | Does the organization maintains 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 shall include data generated from monitoring and measurement, internal audits, management reviews , and other relevant sources. |
| 3 | Does the data analysis output provides information relating to customer satisfaction, conformity to product requirements,supplier performance and quality objectives? |
| 4 | Does it includes 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 it includes the characteristics and trends of processes and products including opportunities for preventive action? |
| 6 | 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 through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review? |
| 6.4.2 | Corrective Action |
| 1 | Does the organization maintains a documented procedure to correct nonconformities and to take corrective actions, both internally and within the supply chain, to eliminate the causes of nonconformities in order to minimize the likelihood of its recurrence? |
| 2 | Are the Corrective actions taken appropriate to the effect(s) of the nonconformity encountered? |
| 3 | Does the process identifies requirements for reviewing a process nonconformity (including customer complaints? |
| 4 | Does it identifies requirements for determining and implementing corrections? |
| 5 | Does it identifies requirements for identifying the root cause of the nonconformity and evaluating the need for corrective actions? |
| 6 | Does it identifies requirements for implementing corrective action to reduce the likelihood that a nonconformity recurs? |
| 7 | Does it identifies requirements for identifying the time frame and responsible person(s) for addressing corrections and corrective action? |
| 8 | Does it identifies requirements for verification of the effectiveness of the corrections and corrective action taken? |
| 9 | Does it identifies requirements for MOC when the corrective actions require new or changed controls within the quality management system? |
| 10 | Are the records of the activities for control of a nonconforming process maintained? |
| 11 | Does the Records identify the activities performed to verify effectiveness of the corrective actions taken? |
| 6.4.3 | Preventive Action |
| 1 | Does the organization maintains a documented procedure to determine and implement preventive actions, both internally and within the supply chain, to eliminate the causes of potential nonconformities in order to minimize the likelihood of their occurrence? |
| 2 | Is the preventive actions appropriate to the effect(s) of the potential problems? |
| 3 | Does the procedure identifies requirements for identifying opportunities for improvements? |
| 4 | Does the procedure identifies requirements for identifying a potential nonconformity and its potential cause(s)? |
| 5 | Does the procedure identifies requirements for evaluating the need for preventive action, including any immediate or short-term action required, to prevent occurrence of a nonconformity? |
| 6 | Does the procedure identifies requirements for identifying the timeframe and responsible person(s) for implementing a preventive action? |
| 7 | Does the procedure identifies requirements for reviewing the effectiveness of the preventive action taken? |
| 8 | Does the procedure identifies requirements for MOC when the preventive action require new or changed controls within the quality management system? |
| 9 | Are the records of the activities for control of potential process nonconformities maintained? |
| 6.5 | Management Review |
| 6.5.1 | General |
| Are the organization‘s quality management system reviewed at least every 12 months by the organization’s management? | |
| Does the management review evaluates the quality management system’s continuing suitability, adequacy, and effectiveness? | |
| Does the reviews includes assessing opportunities for improvement 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 management review includes effectiveness of actions resulting from previous management reviews? |
| 2 | Does the input to management review includes results of audits? |
| 3 | Does the input to management review includes changes that could affect the quality management system, including changes to legal and other applicable requirements? |
| 4 | Does the input to management review includes analysis of customer satisfaction, including customer feedback? |
| 5 | Does the input to management review includes process performance? |
| 6 | Does the input to management review includes results of risk assessment? |
| 7 | Does the input to management review includes status of corrective and preventive actions? |
| 8 | Does the input to management review includes analysis of supplier performance? |
| 9 | Does the input to management review includes review of the analysis of product conformity, including nonconformities identified after delivery or use? |
| 10 | Does the input to management review includes recommendations for improvement? |
| 6.5.3 | Output Requirements |
| 1 | Does the output from the management review includes a summary assessment of the effectiveness of the quality management system? |
| 2 | Does the assessment shall include any required changes to the processes and any decisions and actions, required resources, and improvement to products in meeting customer requirements? |
| 3 | Do the Top management reviews and approves the output of management reviews? |
| 4 | Are management review documented? |
| 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 applying the API Monogram to products developed, maintained, and operate at all times 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 | Does the marking procedure define the authority responsible for application and removal of the API Monogram? |
| 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 application of the API Monogram and its designated license number to API monogrammable products done by API Licensee? |
| 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 maintains 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 provides 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. |
