SOP on Document Control

1.0 Purpose: This SOP describes the process of Documents Control. 

2.0 Scope: To establish and maintain a system which ensures that all quality system documents are controlled.  It covers various records of quality system to show effective operation and Implementation.

3.0 Responsibility: Quality Assurance Manager to ensure that the procedure is followed.

4.0 Materials and Equipment: None

– All the documents of various activities in the quality management system i.e. Quality Manual, SOP’s, Quality formats, have to be approved by the Quality Assurance.

– Master copy of each Quality Management System document is marked as “Master Copy” in Red at each page.

– A master list of all documents is generated in master file showing latest Issue No. and date of issue.

– All the “Master Copy” documents are allotted a unique number to each document.

– A list to determine the distribution of the documents is generated.

– Copy of the approved documents are prepared for distribution.

– Copy is marked as “CONTROLLED” in Red on all pages of the documents.

– The relevant documents are distributed to the various recipients and their signatures obtained and documented.

– Change control of Quality Management System:

– Accepting change requests in the documents.

– Modifying the documents after formal review and approval by the Quality Assurance.

– Indicating revision status, in the document itself to ensure all recipients are well aware of the changes.

– Escalate the changed Issue No. from 0 to 1.

– Added text may be underlined by highlighting for ease to identification of changes.

– Additional change of Control Quality Manual

– Each SOP has a Rev. No. which initially is 00.

– Each section is revised by escalating Revision No. by 1 and printing new effective date.

– The revisions to be recorded in control sheet of all controlled copies.

– New entries to be made in the distribution document for distribution of the revised documents and obtain the recipients signatures.

– The superseded documents are retrieved from the distributors.  One copy is marked superseded in Red and is retained for next two years.  Other are destroyed by shredding.

 

– Analytical records including test certificates, Certificate of analysis with original Data Sheets-Records of Analysis along with the identity and signatures of the personnel responsible for performance of the tests.

– Records of Analysis documents, the data and calculations recorded at the time they are undertaken and are identifiable to specific tests. Also relevant Instrumental graphs if required are available.

– In the events of any mistakes, they are crossed out and not erased, made illegible or deleted and the correct value made alongside.All such alterations to records are initialled by the person making the corrections.