API Spec Q1 Procedure Document Package

List of Documents
 Certification Templates

API Spec Q1 Procedure Document Package

List of API Spec Q1 Procedures – Quality Management System

Procedures
1. Control of Documents Procedure
2. Control of Records Procedure
3. Personnel Competency, Awareness and Training Procedure
4. Contract Review Procedure
5. Risk Assessment and Contingency Planning Procedure
6. Design and Development Procedure
7. Supplier Evaluation and Purchasing Procedure
8. Verification of Purchased Products and Services Procedure

9. Control of Production and Servicing Procedure

10. Inspection and Testing Procedure

11. Validation of Processes for Production and Servicing Procedure
12. Identification and Traceability and Inspection & Test Status Procedure

13. Handling, Storage and Preservation Procedure

14. Control of Customer Property Procedure

15. Preventive and Breakdown Maintenance Procedure
16. Control of Testing, Measuring and Monitoring Equipment Procedure

17. Customer Satisfaction Procedure

18. Internal Audit Procedure
19. Control of Nonconformities Procedure
20. Corrective and Preventive Actions Procedure
21. Analysis of Data Procedure

22. Management of Change Procedure

23. Management Review Procedure

24. Control of Application and Removal of API Monogram Procedure

Product Code: CT17-3 Product Cost: $699.00 USD
API Spec Q1 Procedures Document Package – View Product
Procedure for Contract Review

Sample Document
 Organization Name
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Contract Review Procedure

Contents

1 Purpose ................................................................................................................................................................ 4
2 Scope..................................................................................................................................................................... 4
3 Responsibility...................................................................................................................................................... 4
4 Abbreviation ....................................................................................................................................................... 4
5 Procedure ............................................................................................................................................................. 5
5.1 Enquiry.......................................................................................................................................................... 5
5.2 Determination of Requirements ................................................................................................................ 5
5.3 Review of Requirements............................................................................................................................. 6
5.4 Contract Submission ................................................................................................................................... 6
5.5 Award of Contract ....................................................................................................................................... 6
5.6 Contract/Order Amendment .................................................................................................................... 7
6 Documents/Records Reference ........................................................................................................................ 7

DOCUMENT NO:

REVISION NO:

DATE OF REVISION:

PREPARED BY:

REVIEWED BY:

APPROVED BY:

SIGNATURE:

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Contract Review Procedure

1 Purpose

The purpose is to establish a procedure to ensure that customer purchase orders are
reviewed and managed in a systematic, consistent, and strictly controlled method from
receipt through the order entry process.

2 Scope

Applicable to all customer inquiries for products and services.

3 Responsibility

Sales/Marketing - Determine customer’s requirement, communication with

customers, hosting the contract review process.

Department Heads - Responsible for the review of the requirements along

with Sales/Marketing.

Identifying the contractual risks involved.

4 Abbreviation

QM - Quality Manual

MR - Management Representative

QMS - Quality Management System

MOC - Management of Change

5 Procedure

5.1 Enquiry

All the Enquiries received shall be entered in the Enquiry Register.

All essential features of the enquiry and customer requirements are reviewed and verified. If
necessary, any missing essential customer requirements and essential enquiry features are
obtained and verified either in writing (emails, fax) or verbal phone calls, or both.

Enquiries from the clients will be forwarded to the concerned departments with a
requirement for a quotation, the job will be evaluated, and the commercial department will
raise a quotation to the client.

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Contract Review Procedure

5.2 Determination of Requirements

Information to be recorded while determining the customer requirements shall include the
minimum

Requirements Specified by the Customer

A customer requirement for product manufacture is identified by the Sales/ Marketing

department initially through the following medium:

 Tender Notice put by customer

 Enquiry through emails
 Initial customer communication

Legal and Other Applicable Requirements

Sales/ Marketing department shall identify the legal requirements and ensure the
compliance with them. The legal requirements are as follows;

 Applicable local Acts, Rules and Regulations

 Contractual terms and conditions
 Applicable specifications, codes, etc.

5.3 Review of Requirements

The Contract Review department along with the concerned department heads shall review
the requirements from the enquiry and relevant attachments such as drawings, equipment
specification, and manuals for identifying the scope of work, operational criteria, terms and
conditions and shall include, as a minimum, a verification that

 All requirements are identified and documented;

 Requirements differing from those previously identified are resolved;
 Company has the capability to meet the requirements

5.4 Contract Submission

Upon completion of contract review and acceptance of contract, the sales/marketing

department shall communicate with the client on the acceptance of contract through tender
submission, contract signature, purchase order confirmation, acceptance of change order of
contract or purchase order.

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Procedure for Design and Development

Sample Document
 Organization Name
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Design and Development Procedure

Contents
1 Purpose ....................................................................................................................................................... 4
2 Scope............................................................................................................................................................ 4
3 Responsibility............................................................................................................................................. 4
4 Abbreviation............................................................................................................................................... 4
5 Procedure .................................................................................................................................................... 5
5.1 General .................................................................................................................................................... 5
5.2 Planning .................................................................................................................................................. 5
5.3 Inputs ...................................................................................................................................................... 6
5.4 Outputs ................................................................................................................................................... 6
5.5 Review..................................................................................................................................................... 7
5.6 Verification and Final Review ............................................................................................................. 7
5.7 Validation and Approval...................................................................................................................... 7
5.8 Changes................................................................................................................................................... 9
5.9 Design Package ...................................................................................................................................... 9
6 Document / Record Reference .............................................................................................................. 10

DOCUMENT NO:

REVISION NO:

DATE OF REVISION:

PREPARED BY:

REVIEWED BY:

APPROVED BY:

SIGNATURE:

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Design and Development Procedure

1 Purpose

The purpose of this procedure is to address the control of design and development.

2 Scope

This procedure is applicable to design & development activities for product falling under
product specifications as listed below.

Please list the applicable product specifications here. (Refer API Advisory 6 for products
excluded from design and development).

3 Responsibility

Management Representative - Ensure procedure and record requirements for design and
development of products manufactured follow the guidelines of this procedure.
Design Engineer - Prepare design plan, including plan updates, used for design development.
Identify responsible persons and required resources at each stages of design and throughout the
product realization. Prepare design out put through applicable drawings, calculations, process
sheets, etc.
Design Manager - Review and approve all the stages of design and development.

4 Abbreviation

MR - Management Representative

DAC - Design Acceptance Criteria

DCN - Design Change Note

5 Procedure

5.1 General

The design process is initiated after subsequent plans and contingencies based on risk
assessments are made.

Products that are manufactured against standard specific dimensions that do not require
designs, unless as required by the applicable standard, customer or as per Advisory 6. Design
needs shall be addressed in the product plan.

The API products manufactured that are required to be designed as per the guidelines of this
procedure are as determined in Annex A of this procedure.

5.2 Planning

For products requiring design, the Design Engineer shall prepare a plan to determine various the
stages of the process and identify the controls for design and development. The design engineer
shall consider,

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Design and Development Procedure

a. Product requirement determined by the customer and applicable product specifications;

b. The nature, duration and complexity of the design and development activities;

c. The required process stages, including applicable design and development reviews;

d. The verification and validation activities required for each stages of design and
development;

5.3 Inputs

The Product specific inputs are collected by the Design Engineer through a /product plan who
shall continue to document the design inputs to address the following,

a. Customer-specified requirements

b. Requirements provided from external sources, including API product specification: The
minimum required input necessary to carry out the design must be obtained at the
inquiry stage.

c. Environmental and operational conditions

d. Methodology, assumptions, and formulae documentation

5.4 Outputs

The Design Engineer shall prepare the design outputs that shall address as a minimum;

a. Verify all the input requirements are met for design and development

b. Appropriate information for purchasing (bill of materials, Technical Delivery condition,

etc.), production, and servicing (work instructions, Job Cards, Drawings, ITP, etc) are
provided

c. Reference Design acceptance criteria (DAC)

d. Include identification of, or reference to, products and/or components deemed critical to
the design

5.5 Review

Review shall be performed at suitable stages to evaluate the adequacy, suitability and
effectiveness of the design outputs to meet specified input requirements and to identify any
problems and propose necessary actions.

The design engineer shall ensure any actions required to be taken from the result of review is
documented and addressed.

Records of review and such activities shall be maintained.

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Procedure for Internal Audit

Sample Document
 Organization Name
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Internal Audit Procedure

Contents

1 Purpose ................................................................................................................................................................ 4
2 Scope..................................................................................................................................................................... 4
3 Responsibility...................................................................................................................................................... 4
4 Abbreviation ....................................................................................................................................................... 4
5 Procedure ............................................................................................................................................................. 4
5.1 Audit Plan..................................................................................................................................................... 4
5.2 Internal Auditor ........................................................................................................................................... 5
5.3 Audit Process ............................................................................................................................................... 5
5.3.1 Internal Audit Checklist ...................................................................................................................... 5
5.3.2 Opening Meeting .................................................................................................................................. 5
5.3.3 Performance of Internal Audit............................................................................................................ 5
5.3.4 Audit Reporting .................................................................................................................................... 6
5.4 Audit Review and Closure ......................................................................................................................... 6
5.5 Follow-Up Audit ......................................................................................................................................... 6
6 Documents/Records Reference ........................................................................................................................ 7

DOCUMENT NO:

REVISION NO:

DATE OF REVISION:

PREPARED BY:

REVIEWED BY:

APPROVED BY:

SIGNATURE:

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Internal Audit Procedure

1 Purpose

The purpose of this procedure is to define responsibilities for planning, conducting,

documenting internal audits to verify that work/process activities are consistent with the
defined Management System and to ensure that the system remains effective for achieving
the objectives set by the organization.

2 Scope

Applicable to all Internal Audits carried out in the Organization Name and outsourced
activities.

3 Responsibility

MR - Planning and conducting the internal audit

Internal Auditor - Audit the departments as per the plan

4 Abbreviation

MR - Management Representative

NC - Non-Conformance

NCR - Non-Conformance Report

MOC - Management of Change

5 Procedure

5.1 Audit Plan

MR plans the internal audits to be executed once in at least 12 months for all the processes,
products and outsourced activities. The frequency of internal audit may vary based on
circumstances such as Result of previous audit, Increase of non-conformance, customer
complaints, rejections product, and criticality of processes etc.

The processes identified critical to the quality management system are those processes
associated with design, verification, inspection, and testing.

Internal audit of outsourced activities is to be done at the time the activities are being
performed.

Audit Plan will be established prior to an audit to identify:

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Internal Audit Procedure

1. Activities (including criteria, scope methods)

2. Dates of the audit and
3. Auditor(s) to be assigned

5.2 Internal Auditor

MR shall identify competent and trained internal auditors responsible to conduct the audit
prior to the planning of internal audit. A List of Internal Auditors shall be maintained by the
MR.

The internal auditors shall be responsible for execution of the audit as per the plan.

Internal Auditors, independent of the function being audited, will perform the audit,
scheduled to cover all Quality System and processes.

5.3 Audit Process

5.3.1 Internal Audit Checklist

MR along with concerned department shall prepare an Internal Audit Checklist to identify
requirements of quality management system, requirements of process and activities to be
audited.

5.3.2 Opening Meeting

The audit will start with an opening meeting by the Auditor, wherein the audit criteria,
scope, depth of audit, time, list of attendees, etc., will be agreed. Record of opening meeting
shall be maintained.

5.3.3 Performance of Internal Audit

The Audit will cover and verify the effective implementation of management system,
product specific requirements, critical processes etc.

The finding shall be categorized as Minor NC, Major NC, Observation and the opportunities
for improvements shall be recorded in the Audit Report.

5.3.4 Audit Reporting

Upon completion of audit, a closing meeting will be held with all the attendance
summarizing the finding. The Auditor will send copies of the NCRs and Audit Report to the
MR for further action. Record of meeting shall be maintained.

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