1.0 PURPOSE:
To establish & maintain documented procedure for identification, collection, indexing, access, filing, storage, maintenance, disposition and retention of records related to Quality management system.
2.0 SCOPE:
Applicable to all quality records of the organization related to Quality management system. This procedure is applicable to all the following systems and standards
- ISO 29001:2020/ API Spec Q1, 9th edition
- API Spec …..
- API Spec …..
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3.0 RESPONSIBILITY:
- Management representative/ Design & Quality Systems Manager
- All concerned process owners
4.0 INPUTS:
- Forms & formats
- Document change request
5.0 RESOURCES:
Competent Manpower, Computers, Printer & Internet connection, Stationary, International standards & specifications, XXX Procedures
6.0 PROCEDURE:
Records refer to documented information to be retained by XXX as evidence to have confidence that the processes are being carried out as planned. M.R. shall prepare the list of Records to be maintained across the organization & shall issue the same to the concerned.
6.1 IDENTIFICATION OF RECORDS:
All files/register are identified by using labels which indicates the reference no., description, the period to which the contained records belong.
6.2 COLLECTION OF RECORD:
- The origin of records & generating authorities are described in respective Quality management system procedures, work instruction, quality internal procedure method statements & check lists.
- Each department head shall ensure all the records are legible by the concerned users & specify the collection method in the list of records & shall maintain the records safely.
6.3 INDEXING & FILING OF RECORDS:
- The individual records shall be indexed in chronological order or date / serial nos. wise or subject of records as felt appropriate by the department in charge. The records in the form of book copies shall be kept in chronological order of period for each book, which lead to easy retrieval of any record needed.
- The records shall be filed in a new file when the current file becomes bulky for handling or after the predetermined time period.
6.3 ACCESS OF RECORDS:
- All the personnel performing various tasks addressed in the system shall have access to any record required by them in connection with their work, through the department incharge.
- Whenever required, the records are made available for analysis, audit purpose & for any other reference purpose.
- If contractually agreed, the appropriate records shall be made available to the customers as & when required.
- The records stored in departments or record room shall be provided adequate protection from any type of damage, deterioration or loss.
6.4 DISPOSITION OF RECORDS:
The records after the completion of retention period shall be destroyed by the department by shredding.
6.5 RETENTION PERIOD OF RECORDS :
- The retention period for each record shall be mentioned in the list of records, which is prepared & maintained by M.R.
- Records of internal quality system audit & management review shall be retained for a period of five years by M.R.
However for any other reasons, if felt necessary, any of the records shall be retained further for time period needed by department heads and destroyed subsequently.
6.6 COLLECTION OF RECORD:
- The origin of records & generating authorities are described in respective Quality management system procedures, work instruction, quality internal procedure method statements & check lists.
- Each department head shall ensure all the records are legible by the concerned users & specify the collection method in the list of records & shall maintain the records safely.
6.7 INDEXING & FILING OF RECORDS:
- The individual records shall be indexed in chronological order or date / serial nos. wise or subject of records as felt appropriate by the department in charge. The records in the form of book copies shall be kept in chronological order of period for each book, which lead to easy retrieval of any record needed.
- The records shall be filed in a new file when the current file becomes bulky for handling or after the predetermined time period.
6.8 ACCESS OF RECORDS:
- All the personnel performing various tasks addressed in the system shall have access to any record required by them in connection with their work, through the department incharge.
- Whenever required, the records are made available for analysis, audit purpose & for any other reference purpose.
- If contractually agreed, the appropriate records shall be made available to the customers as & when required.
- The records stored in departments or record room shall be provided adequate protection from any type of damage, deterioration or loss.
6.9 DISPOSITION OF RECORDS:
The records after the completion of retention period shall be destroyed by the department by shredding.
6.10 RETENTION PERIOD OF RECORDS :
- The retention period for each record shall be mentioned in the list of records, which is prepared & maintained by M.R.
- Records of internal quality system audit & management review shall be retained for a period of five years by M.R.
- However for any other reasons, if felt necessary, any of the records shall be retained further for time period needed by department heads and destroyed subsequently.
Sl. No. | Description | Retention Period | Responsibility |
1 | Internal Quality Audit Report | 5 years | Quality Systems Manager |
2 | Minutes Management Review Meeting | 5 years | Quality Systems Manager |
3 | Contract/Job order file including related documents | 10 years from the completion date | Commercial Officer |
4 | Quality records | 5 years or 10 years/As per API product spec requirements | QA/QC Engineer |
5 | Inspection records | 10 years or Part of contract/job order records | Commercial Officer |
6 | API Monogrammed Product records | 5 years or 10 years/As per API product spec requirements | Commercial Officer |
7 | Purchase documents | 10 year after settlement unless specified otherwise | Procurement Engineer |
8 | Finance documents | 5 years after settlement unless specified otherwise | Finance Controller |
11 | Training records | 5 years | HR Manager |
12 | Personnel records of Permanent employment | 5 years after end of employment | HR Manager |
13 | Legal documents | 5 years after closing all legal issues | Chairman |
14 | Product Specification…..records | 5 years | QA/QC Engineer |
15 | Product Specification ….. records | 10 years | QA/QC Engineer |
16 | Product Specification ….. records | 5 years | QA/QC Engineer |
6.11 EXTERNAL RECORDS
- Records prepared or generated by the Sub Contractors / Suppliers which are the part of Quality Management System are maintained as company’s own records.
- Such records generated by the Sub Contractors / Suppliers are verified for accuracy and endorsed by the responsible person receiving these records.
7.0 OUTPUTS
Completed forms & formats
8.0 KEY PERFORMANCE INDICATOR
All records available as per requirements.
9.0 ASSOCIATED DOCUMENTS & RECORDS
DESCRIPTION | FORMAT NUMBER | RESPONSIBILITY |
All Quality records (Master List of records) | XXX/MR/D02 | All functional heads |