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

• DISTRIBUTION LIST

Reshma Verma