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Documented Procedures and Records Required by API Specification Q1 (9th Edition, June 2013)
Document No. CMS/BPD/P-005 Rev. 00 Published On 22 Dec 2019
Author: Nilesh Mistry (Quality Assurance Specialist)

Introduction

API Spec Q1 (9th Edition, June 2013) requires 28 documented procedures and 31 records. This article provides a
comprehensive list of documented procedures and records required by API Spec Q1 (9th Edition, June 2013).

Required Documented Procedures

Sr. # Clause # Topic Description

1 4.3.2.1 Human Resources 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.

Procedure for the identification, distribution, and control of documents required by

2 4.4.3 Control of Documents the quality management system and this specification, including required
documents of an origin external to the organization.

3 4.4.4 Use of External Documents in Product Procedure for the integration of these requirements into the product realization
Realization process and any other affected processes.

4 4.5 Control of Records Procedure to identify the controls and responsibilities needed for the identification,
collection, storage, protection, retrieval, retention time, and disposition of records.

5 5.1.1 Contract Review Procedure for the review of requirements related to the provision of products and
required servicing.

6 5.3 Risk Assessment and Management Procedure to identify and control risk associated with impact on delivery and quality
of product.

7 5.4.1 Design and Development Planning Procedure to plan and control the design and development of the product.

8 5.5.1 Contingency Planning Procedure for contingency planning needed to address risk associated with impact
on delivery and quality of product.

9 5.6.1.1 Purchasing Control Procedure to ensure that purchased products or outsourced activities conform to
specified requirements.

10 5.6.3 Verification of Purchased Products or Procedure for the verification or other activities necessary for ensuring that purchased
Activities products or activities meet specified purchase requirements.

11 5.7.1.1 Control of Production A documented procedure that describes controls associated with the production of
products.

12 5.7.1.2 Controls of Servicing Procedure that describes controls associated with the servicing (see 3.1.21) of
products.

13 5.7.1.5 Validation of Processes for Production Procedure to address methods for review and approval of the processes.
and Servicing

14 5.7.3 Identification and Traceability 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.

15 5.7.4 Product Inspection/Test Status 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.

16 5.7.5 Customer-supplied Property 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.

17 5.7.6.1 Preservation of Product Procedure 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.

5.7.7.1 Inspection and Testing

18 Procedure for inspection and testing to verify that product requirements have been
5.7.7.2 In-Process Inspection & Testing
met.
5.7.7.3 Final Inspection and Testing

Doc. No. CMS/BPD/P-005 Rev.00 © Conformity Management Solutions. All Rights Reserved. Page 1 of 3
 Conformity Management Solutions
Ahmedabad, Gujarat, India
Contact No.: +91 – 84696 16406
E-Mail: [email protected]
Web: conformityblog.wordpress.com

Sr. # Clause # Topic Description

19 5.7.8 Preventive Maintenance Procedure for the establishment of preventive maintenance for equipment used in
product realization.

20 5.8 Control of Testing, Measuring, and Procedure in order to ensure that testing, measurement, and monitoring equipment
Monitoring Equipment is calibrated and maintained and that the equipment is used in a manner that is
consistent with monitoring and measurement requirements.

21 5.9 Product Release Procedure to ensure release of product to the customer shall not proceed until the
planned arrangements (see 5.7) have been satisfactorily completed, unless otherwise
approved by a relevant authority and, where applicable, by the customer.

22 5.10.1 Control of Nonconforming Product Procedure(s) to identify the controls and related responsibilities and authorities for
addressing nonconforming product.

23 6.2.1 Customer Satisfaction Procedure to measure customer satisfaction.

24 6.2.2.1 Internal Audit Procedure to define responsibilities for planning, conducting, and documenting
internal audits.

25 6.3 Analysis of Data Procedure for the identification, collection, and analysis of data to demonstrate the
suitability and effectiveness of the quality management system.

26 6.4.2 Corrective Action 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. Corrective actions shall be appropriate to
the effect(s) of the nonconformity encountered.

27 6.4.3 Preventive Action 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.

28 A.5 Control of the Application and Removal -

of the API Monogram

Required Records

Sr. # Clause # Topic Description

1 4.3.2 Personnel Competence -

2 4.3.2.3 Training and Awareness Records of education, training, skills, and experience.

3 5.1.2 Determination of Requirements Where the customer provides no documented statement of the requirements, the
customer requirements shall be confirmed by the organization and records
maintained.

4 5.1.3 Review of Requirements Records of the results of the review of requirements related to provision of products,
including resulting actions.

5 5.2 Planning Records needed to provide evidence that the product realization processes meet
requirements.

6 5.3 Risk Assessment & Management Records of risk assessment and management including actions

7 5.4.2 Design and Development Inputs -

8 5.4.3 Design and Development Outputs -

9 5.4.4 Design and Development Review -

10 5.4.5 Design and Development Verification -

and Final Review

11 5.4.6 Design and Development Validation -

and Approval

12 5.4.7 Design and Development Changes -

13 5.6.1.5 Supplier Evaluation -

14 5.6.1.6 Outsourcing -

15 5.6.3 Verification of Purchased Products or -

Activities

16 5.7.1.5 Validation of Processes for Production -

and Servicing

17 5.7.3 Identification and Traceability -

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 Conformity Management Solutions
Ahmedabad, Gujarat, India
Contact No.: +91 – 84696 16406
E-Mail: [email protected]
Web: conformityblog.wordpress.com

Sr. # Clause # Topic Description

18 5.7.5 Customer-supplied Property -

19 5.7.6.2 Storage and Assessment -

20 5.7.7.1 Inspection and Testing -

21 5.7.8 Preventive Maintenance -

22 5.8 Control of Testing, Measuring, and Equipment traceability to international or national measurement standards; where
Monitoring Equipment no such standards exist, the basis used for calibration or verification shall be recorded.

23 5.9 Product Release Records to enable identification of the individual releasing the product.

24 5.10.4 Customer Notification Records of notifications of product not conforming to DAC or contract requirements,
that has been delivered.

25 5.10.5 Nonconformities Records of the nature of nonconformities and any subsequent actions taken,
including concessions obtained, shall be maintained (see 4.5).

26 5.11.1 Management of Change (MOC) -

27 6.2.1 Customer Satisfaction -

28 6.2.2.3 Internal Audit -

29 6.4.2 Corrective Action Records shall identify the activities performed to verify effectiveness of the corrective
actions taken.

30 6.4.3 Preventive Action Records of the activities for control of potential process nonconformities.

31 6.5.3 Management Review -

Doc. No. CMS/BPD/P-005 Rev.00 © Conformity Management Solutions. All Rights Reserved. Page 3 of 3