FM-186 API Q1 Conformity Matrix 10th Edition Update
FM-186 API Q1 Conformity Matrix 10th Edition Update
This conformity matrix provides a summary of each requirement in API Spec Q1. It must be used as a
FM-186 | Rev 5.0 | 11/14/2023
reference in conjunction with the Specification to identify how the organization documents and implements
each requirement of API Spec Q1. This summary does not include all the details and distinctions of the
specification requirements and is not a replacement for the API Q1 document. The summaries provided in this
Facility ID: document should not be interpreted to be clarifications or interpretations of the API Q1 document.
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
5.3.2
Risk Assessment
5.3.2.1 Product Delivery Risk assessment associated with product delivery includes items (a) & (b)
5.3.2.2 Product Quality Risk assessment associated with product quality includes items (a) & (b)
5.3.2.3 Changes Impacting Product If changes identified in (a)-(e) negatively impact quality of product, risk assessment is performed
Quality
5.3.3 Contingency Planning When contingency plan is required based on assessed risk, contingency plan includes (a) - (c)
Contingency plan(s) is documented, communicated, and updated
5.3.4 Records Records of risk assessment and management including actions taken are maintained
5.4
Design
5.4.1 General Organizations responsible for design conform to the requirements of 5.4
5.4 design requirements are not applicable for production activities, servicing, storage, distribution, or logistics
5.4.2 Design Planning Documented procedure to plan and control the design process
The procedure addresses items (a) - (f)
When design activities are outsourced or performed at a different location within the organization, the
procedure identifies controls for the requirements of 5.4
When design is outsourced, organization remains responsible for design and demonstrates supplier
conformance
5.4.3 Design Inputs Design inputs identified and reviewed
Any identified design input issues are addressed
Inputs include functional and technical requirements
Inputs include items (a)-(g)
Records of design inputs are maintained
5.4.4 Design Outputs Outputs are documented
Outputs conform to items (a) - (f)
Records of design outputs are maintained
5.4.5 Design Review Design reviews performed per items (a) & (b)
Review(s) participants include representatives of functions concerned with the the design stages being
reviewed
Records of the results of the review(s) and any necessary actions are maintained
5.4.6 Design Verification and Design verification and final review conducted and documented
Final Review
Records of design verification, any necessary actions, and the final review are maintained
5.4.7 Design Validation and Design validation conducted per organization procedure to ensure that product satisfies specified
Approval requirements
Validation completed before product delivery, when possible
Completed design approved after validation
Company: Instructions
This conformity matrix provides a summary of each requirement in API Spec Q1. It must be used as a
FM-186 | Rev 5.0 | 11/14/2023
reference in conjunction with the Specification to identify how the organization documents and implements
each requirement of API Spec Q1. This summary does not include all the details and distinctions of the
specification requirements and is not a replacement for the API Q1 document. The summaries provided in this
Facility ID: document should not be interpreted to be clarifications or interpretations of the API Q1 document.
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
Final design approved by competent personnel that did not develop the design
Records of the design validation, approval, and any necessary actions are maintained
5.4.8 Design Changes Design changes are identified
Design changes reviewed, verified, validated and approved prior to implementation
Review of design changes includes evaluation of the effect of changes on the product and components in
product realization and products already delivered
The review of design changes includes an evaluation to determine if customer notification is required
Changes to the design performed in accordance with the organization's procedure
Records of design changes, reviews of those changes, and any necessary actions are maintained
5.5
Purchasing
5.5.1
Purchasing Control
5.5.1.1 Procedure Documented procedure for the purchase of products, components and/or activities needed for product
realization
The procedure addresses items (a) - (g)
5.5.1.2 Initial Supplier Evaluation— Initial critical supplier evaluation addresses the scope of supply and is site-specific
Critical Purchases Initial critical supplier evaluation includes (a) verification of the supplier QMS
Initial critical supplier evaluation includes (b) verification of the supplier's internal and supply chain controls
Initial critical supplier evaluation includes (c) one or more of (1), (2), or (3) based on identified risk
For suppliers of critical purchases with high-risk severity where an on-site assessment is not performed, a
remote assessment and inspection/testing/verification is performed
Remote assessments include verification of objective evidence through real-time A/V observation of activities
and documentation
Supplier evaluation performed in accordance with this section requirements when change of scope or site
5.5.1.3 Initial Supplier Evaluation – Where 5.5.1.2 is not applied, the initial evaluation includes items (a) & (b)
Critical Purchases –
Customer Specified,
Proprietary, and/or Legal
Limited Scope of approval for customer-specified supplier is limited to the relevant customer contract
5.5.1.4 Initial Supplier Evaluation— For noncritical purchases, the evaluation criteria satisfies 5.5.1.2 or one or more of items (a) - (c)
Noncritical Purchases
5.5.1.5 Supplier Reevaluation Reevaluation frequency determined based on identified risk and supplier quality performance.
Re-evaluation of suppliers of critical purchases meets the requirements of 5.5.1.2
Re-evaluation of suppliers of critical purchases specified by the customer or limited by proprietary or legal
requirements meets the requirements of 5.5.1.3
Re-evaluation of suppliers of noncritical purchases meets the requirements of 5.5.1.4
Company: Instructions
This conformity matrix provides a summary of each requirement in API Spec Q1. It must be used as a
FM-186 | Rev 5.0 | 11/14/2023
reference in conjunction with the Specification to identify how the organization documents and implements
each requirement of API Spec Q1. This summary does not include all the details and distinctions of the
specification requirements and is not a replacement for the API Q1 document. The summaries provided in this
Facility ID: document should not be interpreted to be clarifications or interpretations of the API Q1 document.
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
5.5.3.1 General Documented procedure for verification of purchased products, components or activities
5.5.3.2 Critical Purchases For critical products, components or activities, the organization's procedure for verification addresses items
(a) - (c)
5.5.3.3 Noncritical Purchases For noncritical products, components or activities, verification is in accordance with the documented
procedure
5.5.3.4 Records Records of verification activities and evidence of conformity to specified requirements are maintained
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
5.7 Product Release Documented procedure for release of products to the customer
Product release does not proceed until the planned arrangements have been completed
Only release products that conform to requirements or released under concession
Records are maintained to enable identification of the individual releasing the product
5.8
Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)
5.8.1 General Determine the TMMDE requirements
Determine the TMMDE needed to provide evidence of conformity
TMMDE used to provide evidence of product conformity/monitor process parameters is controlled
Company: Instructions
This conformity matrix provides a summary of each requirement in API Spec Q1. It must be used as a
FM-186 | Rev 5.0 | 11/14/2023
reference in conjunction with the Specification to identify how the organization documents and implements
each requirement of API Spec Q1. This summary does not include all the details and distinctions of the
specification requirements and is not a replacement for the API Q1 document. The summaries provided in this
Facility ID: document should not be interpreted to be clarifications or interpretations of the API Q1 document.
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
Includes TMMDE owned by organization, employee-owned, and TMMDE from other sources
TMMDE calibrated at specified intervals
When the calibration interval is based on the date of first use, the date of first use is documented
When calibration of third-party, proprietary, and customer-owned TMMDE is limited by customer, contract,
or licensing agreements, records are maintained documenting the imposed limitations
5.9
Control of Nonconforming Product
5.9.1
Procedure
5.9.1.1 General Documented procedure that outlines the controls, responsibilities, and authorities for handling
nonconforming products during product realization and after delivery
5.9.1.2 Nonconforming Product Procedure for addressing nonconforming products identified during product realization includes items (a) - (d)
During Product Realization
5.9.1.3 Nonconforming Product Procedure for addressing nonconforming products delivered to the customer includes items (a) - (d)
After Delivery
5.9.2 Nonconforming Product Address nonconforming products by performing one or more of (a) - (d)
5.9.3 Release of Nonconforming Release under concession of nonconforming products is permitted when evaluation is conducted and release
Product Under Concession is authorized
Authorized release if one of (a)-(c) is satisfied
Company: Instructions
This conformity matrix provides a summary of each requirement in API Spec Q1. It must be used as a
FM-186 | Rev 5.0 | 11/14/2023
reference in conjunction with the Specification to identify how the organization documents and implements
each requirement of API Spec Q1. This summary does not include all the details and distinctions of the
specification requirements and is not a replacement for the API Q1 document. The summaries provided in this
Facility ID: document should not be interpreted to be clarifications or interpretations of the API Q1 document.
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
Organization does not release product not conforming to DAC or contract requirements without customer
authorization
5.9.4 Customer Notification of Organization notifies customers of product not conforming to DAC or contract requirements, that has been
Nonconforming Product delivered
Records of notifications are maintained
5.9.5 Records Records of nonconformities are maintained and include items (a) - (d)
5.10
Management of Change (MOC)
5.10.1 General Documented procedure for MOC
The MOC procedure addresses items (a) - (f)
5.10.2 MOC Application Use MOC for changes that may negatively impact the quality of the product
5.10.3 MOC Notification Notify relevant internal personnel about the change and the associated risk
When required by a contract, notify the customer of the change and the associated risk
MOC Notifications are documented
5.10.4 Records Records of MOC activities are maintained
6
Quality Management System Monitoring, Measurement, Analysis, and Improvement
6.1 General Plan and implement monitoring, measurement, analysis and improvement processes to ensure QMS
conformity
Continually improve effectiveness of QMS
QMS Monitoring, measurement, analysis and improvement includes determination of applicable methods,
including data analysis techniques, and extent of their use
6.2
Monitoring, Measuring, and Improving
6.2.1 Customer Satisfaction Maintain a documented procedure to monitor customer satisfaction
The procedure addresses items (a) & (b)
Records of the results of customer satisfaction information are maintained
6.2.2
Internal Audit
6.2.2.1 General Organization shall conduct internal audits
Documented procedure to define responsibilities for planning, conducting, and documenting internal audits
Identify the internal audit criteria, scope, frequency, and methods
Planning of internal audits considers results of previous audits, criticality of processes, and changes to the
QMS
All processes of the QMS are audited at least once every 12 months
If the QMS is not audited as one consolidated audit, the time between each part does not exceed 12 months
For processes identified as critical to product realization, audits include observation of the activity and
evaluation of conformity
6.2.2.2 Performance of Internal Audits performed by competent personnel who are independent of those who performed or directly
Audit supervise the audited activity
Company: Instructions
This conformity matrix provides a summary of each requirement in API Spec Q1. It must be used as a
FM-186 | Rev 5.0 | 11/14/2023
reference in conjunction with the Specification to identify how the organization documents and implements
each requirement of API Spec Q1. This summary does not include all the details and distinctions of the
specification requirements and is not a replacement for the API Q1 document. The summaries provided in this
Facility ID: document should not be interpreted to be clarifications or interpretations of the API Q1 document.
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
b) Each licensee shall develop and maintain an API Monogram marking procedure that documents the
marking/monogramming requirements specified by this annex and any applicable API product specification(s)
and/or standard(s)
The marking procedure shall:
1) define the authority responsible for application and removal of the API Monogram and license number;
2) define the method(s) used to apply the Monogram and license number;
3) identify the location on the product where the API Monogram and license number are to be applied;
4) require the application of the date of manufacture of the product in conjunction with the use of the API
Monogram and license number;
5) 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); and
6) define the application of the additional API product specification(s) and/or standard(s) marking
requirements.
c) Only an API licensee shall apply the API Monogram and its designated license number to API
monogrammable products.
d) The API Monogram and license number, when issued, is site-specific and subsequently the API Monogram
shall only be applied at that site specific licensed facility location.
e) The API Monogram may be applied at any time appropriate during the production process but shall be
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 Each licensee and/or applicant for licensing shall maintain a current design package for all of the applicable
Requirements products that fall under the scope of each Monogram license. The design package information shall provide
objective evidence that the product design meets the requirements of the applicable and most current API
product specification(s). The design package(s) shall be made available during API audits of the facility.
In specific instances, the exclusion of design activities is allowed under the Monogram Program, as detailed in
Advisory # 6.
A.7 Manufacturing Capability Facilities with capabilities that are limited to the processes or activities defined below do not meet the
manufacturing capability requirements to produce new products, and therefore, shall not be licensed or be
the basis for licensing under the API Monogram Program:
— Capabilities that are limited to performing final inspection and testing of the product;
— Buying, selling and/or distributing finished products and materials;
— Design and development activities;
— Tearing-down and/or re-assembling of products/components; and
— Repairing or remanufacturing of existing, used, worn or damaged products.
In all instances where requirements for manufacturing or manufacturing facilities are explicitly identified
within the API product specification, those requirements shall take precedence over this advisory.
Company: Instructions
This conformity matrix provides a summary of each requirement in API Spec Q1. It must be used as a
FM-186 | Rev 5.0 | 11/14/2023
reference in conjunction with the Specification to identify how the organization documents and implements
each requirement of API Spec Q1. This summary does not include all the details and distinctions of the
specification requirements and is not a replacement for the API Q1 document. The summaries provided in this
Facility ID: document should not be interpreted to be clarifications or interpretations of the API Q1 document.
Identify in each cell (Tier 1 , Tier 2, or Tier 3) the document(s) where your organization addresses each
requirement of the Specification. If you are excluding any clauses, indicate “Excluded”.
Date:
A.8 Product Marking These marking requirements shall apply only to those API Licensees wishing to mark applicable products in
Requirements conjunction with the requirements of the API Monogram Program.
A.8.2 Product Specification Manufacturers shall mark products as specified by the applicable API specifications or standards. Marking
Identification shall include reference to the applicable API specification and/or standard. Unless otherwise specified,
reference to the API specifications and/or standards shall be, as a minimum, “API [Document Number]” (e.g.
API 6A, or API 600). Unless otherwise specified, when space allows, the marking may include use of “Spec” or
“Std”, as applicable (e.g. API Spec 6A or API Std 600).
A.8.3 Units Products shall be marked with units as specified in the API specification and/or standard. If not specified,
equipment shall be marked with U.S. customary (USC) units. Use of dual units [USC units and metric (SI) units]
may be acceptable if such units are allowed by the applicable product specification and/or standard.
A.8.4 Nameplates Nameplates, when applicable, shall be made of a corrosion-resistant material unless otherwise specified by
the API specification and/or standard. Nameplate shall be located as specified by the API specification and/
or standard. If the location is not specified, then the licensee shall develop and maintain a procedure detailing
the location to which the nameplate shall be applied. Nameplates may be attached at any time during the
manufacturing process.
The API Monogram and license number shall be marked on the nameplate, in addition to the other product
marking requirements specified by the applicable product specification and/or standard.
A.8.5 License Number The API Monogram license number shall not be used unless it is marked in conjunction with the API
Monogram. The license number shall be used in close proximity to the API Monogram.