STANDARD OPERATING PROCEDURE
Title : Procedure For Good Documentation Practices
Department : Quality Assurance
- To lay down a procedure for good documentation practices.
- This procedure is applicable for all Production, Quality Control, Quality Assurance, Warehouse, Engineering & utility and Personnel and Administration departments.
- Manager-Quality Assurance
Design and Preparation of Documents
- The master copies of all the documents like SOP’s, STP’s, specifications and test methods etc. shall be controlled by the Quality Assurance department.
- The basic format of each document shall be kept intact.
- The document shall be prepared in lucid and easy to understand language.
- Whenever the photocopy of the original document used, it shall be ensured that the photocopy is clear and the text is readable.
- Whenever register used for recording purpose, each page shall be identified by page number.
- Recording and Review of Documents
- Data shall be recorded directly into the document.
- Data shall be recorded concurrent to the activity performed.
- Postdated or backdated documentation shall be strictly not allowed.
- No data shall be written on scrap paper, rough paper or personal notebooks. One is allowed to record the data in a raw data register.
- All the manual recording of data in document shall be done with ‘Blue Ball Pen’ only.
- No space or column shall remain empty in the document, wherever no recording is required, N/A (Not applicable) shall be written in the respective column.
- The word ‘do’ and “ ” shall not be used during recording.
- In case any new word is to be inserted between two word, use ‘^’ to write a new word.
- The date (Wherever applicable) shall be written as DD/MM/YY.
- The whole data shall be cross checked or reviewed by the QA and signed with name and date using ‘Green Ball Pen’ only.
- The data sheet shall finally be checked and signed by authorized signatory with permanent ‘Blue Ball Point Pen’ only.
- Correction in wrong Entries
- In case of any wrong entry made or observed, shall be corrected by a single line cut with initial and date. If in case required the additional document/ page generate the requisition to QA department as per format No.
- Distribution of Documents
- QA Department shall control and record the distribution of documents related to manufacture and control of the product.
- Each copy shall be stamped ‘Controlled Copy’ in red colour at right side of page.
- Whenever a revised version of an existing document is issued, the existing version shall be retrieved immediately by the QA department.
- Storage /Disposal of Documents
- All the current version of the master documents shall be stored under the control of QA department.
- Laboratory has different types of documents and the records. All record / document have their current issue number. The old and previous records have specified time for their retention in the laboratory. The salvage of the relevant documents is recorded in a format.
- Adequate measures shall be taken to preserve all the documents in neat and clean condition.
- All the retrieved controlled copies shall be destroyed immediately.
- The document / record, after completion of the retention time are destroyed and disposed of by following means under the supervision of the Head of the Department.
- Shredding in a shredder
- Burying in an earthen pit
SOP – Standard Operating Procedure
QA – Quality Assurance
|Record the Retention time of Document
|Retention time of Record
|Dispose of Document and Record
|Additional Document Requisition
- DISTRIBUTION LIST
|VP-Plant & Operations