Procedure For Good Documentation Practices

by

STANDARD OPERATING PROCEDURE

Title :  Procedure For Good Documentation Practices

Department : Quality Assurance

  • OBJECTIVE                                                    
    •   To lay down a procedure for good documentation practices.
  • SCOPE
    • This procedure is applicable for all Production, Quality Control, Quality Assurance, Warehouse, Engineering & utility and Personnel and Administration departments.
  • RESPONSIBILITY
    • Officer/Executive-QA.
  • ACCOUNTABILITY
    • Manager-Quality Assurance
  • PROCEDURE

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

 

 

  • ABBREVIATIONS

SOP       –    Standard Operating Procedure

QA        –    Quality Assurance

 

  •          FORMAT
Sr. No. Title Format No.
Record the Retention time of Document
Retention time of Record
Dispose of Document and Record
Additional Document Requisition

 

  • DISTRIBUTION LIST
Copy No. Department
Quality Assurance
VP-Plant & Operations