QSP 02 - Record Control Procedure
QSP 02 - Record Control Procedure
UNIT-III
QUALITY SYSTEM PROCEDURE
[ISO 9001: 2008, ISO/TS 29001: 2010 & API SPEC Q1, 8TH EDITION]
RECORD CONTROL PROCEDURE
AMENDMENT HISTORY
1.0 PURPOSE
To define the methodology followed by QuEST GLOBAL MANUFACTURING PRIVATE LIMITED for coding,
review, approval, issue, control and changing records, data preparation, maintenance and control of Quality
Management System records.
2.0 SCOPE
This procedure is applicable to all the levels of documents pertaining to ISO 9001: 2008, ISO / TS 29001:
2010, API Spec Q1, 8th edition.
3.0 RESPONSIBILITY
1. Management representative
4.0 DESCRIPTION
This procedure describes about the identification, storage, protection, retrieval, retention and disposal of all
the records dealt by the organization.
Records are generated during operational processes to provide evidence of the effective operation of the
business and Quality Management System. The process for control of records will illustrate the steps taken to
ensure that all records essential to the business and the QMS are controlled, to prevent deterioration,
damage or loss, and ensure fast retrieval for audit and review purposes.
Amendment to formats used for records is carried out by MR with a request for change from the concerned
process owners. The same is updated in the Master list of records.
The records are retained for a minimum period of 5 years or as specified by the customer / standard
requirement and are then disposed under controlled condition.
Coding, review, approval, issue, control and changing documents and data
6.0 RECORDS
Management
Representative
Process Heads
8.0 PROCEDURE
1. If there is any need for records revision the concerned member raises Engineering Change
Request Form, describing the changes required, the reasons and forwards the same to MR -
QMS.
2. Management Representative - QMS assigns a serial number for the request, reviews
requirement and on acceptance forwards to approval authority.
3. Approval authority reviews the request and analyses the impact it has on the rest of the system.
4. Approval authority approves the Engineering change request form and issues to MR -QMS.
5. MR - QMS incorporates the changes in the relevant records and revises accordingly. Wherever
possible, the changes made in the records are highlighted in Italic Font, to differentiate the
changes made alone. Revised record is issued to the concerned Process for appropriate use.
6. MR - QMS issues records to the requester through an issue slip, which describes the records
name, number and revision level. All the records are legible and readily identifiable.
7. MR - QMS receives the signed copy of the issue control Register, as an acknowledgment of
issuing the records.
8. All records are identified using unique numbering system by Process Owners.
9. The originator of record has to ensure that all required regulatory and customer requirement are
considered
10. Respective Departmental heads store the records in separate files and are indexed date wise.
11. Each file is identified with file description for easy access of the records.
12. Internal quality system audit records and the Management review records are retained for 5
years and are maintained by MR.
13. If contractually agreed, MR / Manager QA ensure that the records are available for review to the
customer.
14. All records are legibly written and are stored in such a way that they can be easily retrieved.
15. Any supplier records required are intimated through the Materials purchase order and are
maintained by the Purchase process
1. Records prepared or generated by the Sub Contractors / Suppliers which are the part of Quality
Management System are maintained as company’s own records.
2. Such records generated by the Sub Contractors / Suppliers are verified for accuracy and endorsed
by the responsible person receiving these records.
3. The Supplier records are retained for a minimum period of 5 years or as specified by the customer /
standard requirement and are then disposed under controlled condition.
Normally, it’s the process owner, under the leadership of MR, does this activity
4. Records required by applicable industry, product standards such as ASTM, API, ISO, IS, DIN
,NACE, BS,EN ,ASNT,ASME etc. as well as Customer prescribed standards are retained for a
period of minimum 5 Years or as specified by the standards.
5. All other records required for demonstrating conformity to QMS as well as effective operation of
QMS are retained for a minimum of 5 years.