Purpose:
To establish a procedure for identification, preparation, approval, issue, amendment and numbering of documents and records to ensure availability of pertinent issues of documents at the places of use as per IATF 16949:2016
Scope:
This process is applicable for all types of documents & records used within a Qualty Management System. It covers Quality Management System Manual, Quality Procedures, Process documents, Work Instructions, Formats, Inspection Standards, Process Sheets and external origin documents in the organization
Responsibility:
The MR is overall responsible for the implementation of this procedure. All Heads are responsible for implementing this procedure in their respective areas.
| S.No | Document Name | Prepared By | Issued By | Approved By |
|---|---|---|---|---|
| 1 | QMS Manual | MR | MR | MD |
| 2 | QMS Procedure | MR | MR | MD |
| 3 | QMS Formats | MR | MR | Plant Head |
| 3 | Process Documents (PFD, CP, PFMEA, WI) | Quality Head | MR | QA Head |
| 4 | PPAP | Quality Head | MR | QA Head |
| 5 | External Documents | ‘—- | MR | ‘———‘’ |
Description:
- MR prepares a ‘Master List of Documents indicating various types of documents that include preparation, identification, responsibility/authority/ review/approval and distribution of the same. All master copies will be kept with MR
- MR prepares the document through feedback received from HOD & whenever its need is felt based on requirements (e.g. Operational, Standards, Legal, Customer etc.)
Identification of documents:
- A title and document number identify all documents.
- Each document carries its revision no. indicated as Rev No.00, Rev 01, and Rev 02 etc.
- Quality Manual is identified as ‘QSM-01’.
- Quality management procedures are identified as XX-QMS-YY where XX is the company’s short name.
- Quality Formats identified as ‘XX / F / YY’, where:
- XX: Department code where the document belongs
- YY: Document’s serial No in that category.
Department Codes:
- NPD: Engineering Department
- HR: Human resources Management
- MKT: Marketing
- PRD: Production
- PUR: Purchase
- QA: Quality Assurance
- STR: Stores and dispatch
- TR: Tool Room
- MNT: Maintenance
Document Code:
- QMS: Quality Management System
- QSM: Quality Manual
- WI: Work Instruction
- IS: Inspection Standard
- F: Format
Review and approval of documents:
| S. No | Activity | Responsibility | Frequency |
|---|---|---|---|
| 1 | Review of the Standards/ Format/ WI/ Procedures etc. | Quality In-charge / MR | In the event of changes, once a year, Customer specific requirements, Customer complaint |
| 2. | Preparation of Standards | Quality In-charge /MR | As per the APQP timing Plan |
| 3 | Authorization of Standards | Quality In-charge/ Plant In-charge/MD | Once |
| 4 | Submission to customer | Quality In-charge | As per the APQP timing plan |
| 5 | Updating of standards | MR | After every change |
| 6 | Issue of the revised standard | MR | After every change |
- The documents (Quality Manual, Procedures, Formats, Drawings, Newly formed documents, amended documents & amendments required by customer) are reviewed by M.R. with the concerned department head.
- The review frequency of documents will be once a year.
- Approval of documents with sign and date by the department head, if documents are satisfactory; otherwise amend documents.
- If no change during the review, the master list of documents is updated, review date and next review date are written.
- After approval of the document, the original copy (Master Copy) will be retained by M.R.
- Affix ‘Master Copy Stamp’ in blue color at the back side of each page.
- Make an entry in the master list of documents.
Documents Distribution:
- Make the required no. of copies of documents for distribution, and put the ‘Controlled Copy’ stamp in red color on the front of each page of the document.
- Distribute the documents to all concerned HOD/functions owners as per the distribution sheet (Master list).
- If any old or invalid/obsolete copy is to be withdrawn, do it as per the system of withdrawal of old/obsolete documents.
Preservation and Storage of Documents:
- Distribute the documents to all concerned HOD/Processes department/functions owners as per the distribution sheet (Master list). If any old/obsolete copy is to be withdrawn, do it as per the system of withdrawal of old/obsolete documents
- File all the generated documents sequentially and keep the file at a defined location. For documents in soft copies, mention the location/directory/path in the Master List of Documents.
- Provide proper visual identification on all locations where documents are kept (in hard copies) to ensure they are readily retrievable.
- Review the list of documents every year and discuss with the concerned HOD about the disposal of documents that have crossed the retention period and take suitable decisions for disposal.
Revision of documents:
- User of document/ requester initiates ‘Document Change Request’ with approval of concerned HOD whenever a need is felt to amend the existing document and send it to M.R. OFFICE. If MR changes the document or format there will be no requirement for a document change request
- M.R. Review the change request and decide if the change is appropriate and can be incorporated (if required discuss with requester/relevant Function also).
- If the request is valid, make necessary changes with the latest rev. no. and enclose/incorporate the nature of change in the amendment record.
- Re-approve & Re-distribute as per.
- Note 1: Review and Re-approval have to be done by the M.R. OFFICE and Concern Authority.
- Note 2: No document change request is needed if changes are proposed by M.R.OFFICE for the M.R. document. In such cases, only amendment record is maintained.
Withdrawal of old/obsolete documents:
- Whenever withdrawal of any old/obsolete document is required, take back all controlled copies of documents from all departments/functions as per the document distribution record.
- Positively destroy all obsolete documents except one copy for reference purposes.
- Put the stamp ‘Obsolete’ in red color on this one copy to prevent its unintended use.
Control of external origin documents :
- Documents of external origin are determined by the process owners and received from various sources like customers, regulatory bodies etc. Documented information of external origin i.e. Drawing, Specification, National /International Standard is determined by the organization in hard copy/soft copy.
- Maintain a document distribution record whenever any individual takes documents for reference/use, make proper entries and after the documents are returned, update it. In case any external document is to be distributed among multiple persons, then mark the Original Copy received as the Master Copy and issue a Controlled Copy. Document issued by document issue record.
- Whenever a new document is added, update the master list.
- At least once in a year, get information through the Internet or from the standard originating body or the Customer regarding the latest revision status of documents
- Whenever a change in documents/standards comes to notice, get/purchase the document and update the master list.
- Put the ‘OBSOLETE’ stamp in red color on the superseded document.
Usage of Various Formats:
Various formats being used by the concerned department can be produced either in Soft/Hard Copy to ensure that the controlled copy of the same is available with the HOD.
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Control of Records:
Identify all the records to be maintained in the department/function on the basis of applicable processes or as per the following requirements:
- As mentioned in the IATF-16949 standard.
- Statutory and Regulatory requirements
- Customer-specific requirements
Prepare a “Record retention policy” indicating the retention period for each record.
- Generate legible records as and when needed in hard/soft copy in the necessary Formats; Utilize customer-provided and Legal formats, wherever applicable.
- File all the records, generated in formats, in respective files sequentially.
- Provide proper visual identification on all locations where records are kept (in hard copies) to ensure they are readily retrievable.
- The organization maintains APQP/PPAP Documents and tooling records including Maintenance of Tooling, Product Development and Manufacturing process design records, Purchase orders, Customer Contracts and Amendments records till the product is active for production plus one calendar year or specified by the customer. While deciding the retention period, due considerations are given as mentioned above.
- Review the list of records retention every year, and discuss with MR OFFICE about the disposal of records that have crossed the retention period and take suitable decisions for disposal.
- Disposal of the record will be by tearing the record.
- Records maintained on the computer can be deleted after the retention period is over.