This article is the complete guide on how control of documented information works in industry.
Learning documentation is the key challenge for every quality engineer.
And they are continuously try to learn those, but the correct method and explaination is the base factor to learn quickly.
Here we learn, how documents are control in any organization.
How documentations are structurize and maintain to comply with standards and requirements.
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Lets dive in.
What is a document in organization?
The document in any organization is the official writing or guideline provide the information, evidence and proof within organization.
Any information in organization written on paper and provide to the employee as a guideline, work instruction, standard, procedure all are the documents.
What is Control of Documented information?
Every documents in organization are identify by unique ID. Where it has a proper identification method to have traceability with wich department, and sub department where it belogs to.
QMS coordinator is the one who do this document control process.
Procedure of Control of Documented information Example
To establish a system, that will ensure only relevant and current documents are used in the organization.
[It is the statement shows actual purpose of this procedure]
Applicable for all documents and requirements of IATF 16949:2016. This includes Quality Policy, Quality Manual, Procedures, Work instructions, Records and formats includes external documents such as standards and customer design and drawings.
[It is the scope of our procedure]
3.0 Users or Responsibility:
QMS coordinator to co-ordinate maintain and control of documents in each function/department.
4.0 Procedure for Control of Documented information:
DISTRIBUTION, ACCESS, RETRIEVAL AND USE:
- Before release, we need to verify and approve all documents for adequacy and correctness, updating documents as needed through document change notes/requests. Additionally, all new and revised documents are recorde in document list before release.
- It is easily available and suitable for use case, where and when it is needed;
- It is properly protected (e.g. from loss of integrity and confidentiality, inappropriate use).
IDENTIFICATION OF DOCUMENTS AND RECORD
- Quality System Documentation is uniquely identified using identification method as below.
- Type of documents includes QD: For Documents and QF: For Formats and Records. Types could be format, procedures, files, work instructions, drawings, check points, process standard & International standards.
- Department Code includes the unique code of specific department the format is used for. For example For Quality=QU, Production=PD, Purchase=PU, Human Resource=HR, etc.
- Serial number are the numbering system followed by initial information, for example 001, 002,… 00n.
CONTROL OF CHANGES (VERSION CONTROL);
- Assign a unique issue number, rev no and rev date to all Quality Management System (QMS) documents. After modification or update in any document are manage by revision number. Initial revision number are 0, then futher revised documents numbering from 1 to onwards. Document change note refered to track and implement those changes.
- All controlled documents should have a rubber stamp “Controlled copy” put on them on every page in the front right bottom side before release or issue of any documents by QMS coordinator. Controlled copy stamp is in the custody of HOD (QA).
- All Master copy documents should have a rubber stamp “Master Copy” put on them on every page in front left bottom side. A master list of all Quality Management System related documents made. QMS coordinator are maintaining master list reflecting their current revision, unique issue number, and rev date. prepared & approved by status and distribution control.
STORAGE AND PRESERVATION, INCLUDING PRESERVATION OF LEGIBILITY
- All documents identified are legible, easily available, and control distribution at point of use.
- Forms carry it’s format no. and rev. number. Also it is approved and indicated by a stamp on it. The Master Copy stamp on front left bottom side and Controlled Copy stamp on front right bottom side.
- All documents should be easy to distribution, access, retrieval and use;
- storage and preservation, including preservation of legibility;
- control of changes (e.g. version control);
DOCUMENTS OF EXTERNAL ORIGIN
All documents of external origin like reference national & international standards are identified, maintained and
distributed as per list of external origin.
RETENTION AND DISPOSITION OBSOLETE DOCUMENTS
QMS coordinator identify all obsolute documents and marked those using obsolute stamps. All obsolute copies are store in seperate file, so that no one can access it, to avoid any nonconformity within organization. The obsolute file are keep only for reference purpose.
5.0 Reference documents
|Master list of Documents
|Master list of Records and Formats
|Master list of Work Instruction
|Change Request Note
|Employee Training Record
7.0 Change History
|Control of documented information Procedure released