SOP on the use of SOP

Quality Control
1

Please can someone help me with the procedure on how to train staff on the use of SOP?
Thank you

2

The procedure on how to train staff members on using any SOP correctly should cover following points,

  • To use current version pf SOP (To check for current version and date of implementation of SOP / Effective date)
  • To ensure that “Obsolete” version of same SOP is not in use. And is removed from the current SOPs file.
  • To ensure that user person is trained on SOP for SOP to understand basic structure of SOPs.
  • To train the staff on significance of current and Obsolete versions of SOP, Effective date etc.
  • To explain the terminologies like, Objective, Scope, Responsibilities, Procedure, References, Revision history of that SOP, What is “Current, Obsolete, Withdrawn” versions of SOP.
  • To differentiate between Annexures, Attachments, Flow charts, Decision trees etc. which are parts of any SOP.
  • To make them understand what is “Revision History, Issue number, Version number, Effective date, References” etc. as a part of basic structure of SOP.
  • To understand how to use blank forms attached to the SOP.
  • To understand the meaning of “Controlled copy, Obsolete copy, Withdrawn copy” of SOP.
  • Significance of “History of changes / Revision History” which is a part of SOP.

Please include above aspects in the training material on “How to train staff on use of SOP.”

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3

Sir what is withdrawn copy of Sop .is it implemented in form of stamp.we r having stamps of both controlled and obsolete sops .at the time of sop issuance controlled copy stamp is used and for previous version SOP obsolete is used.and the old issued copies of sops are retrieved and destroyed.but there is no withdrawn copy.

4

Generally the term “Withdrawn copy” of SOP is used when any SOP is permanantly withdrawn from the QA System. Foe example: if any instrument or equipemt is permanantely removed from production area or QC Laboratory then the Operation, Cleaning, Maintainance & calibration SOPs of that instrument / equipment should be withdrawn permanantly. There is no replacement of such SOPs. In such cases master copies of these SOPs should be stamped as “Withdrawn”.
We use the term “Obsolete” in case the old version of SOP is replaced by the new / current version.
In both the cases, “Withdrawn” OR “Obsolete” stamp should be affixed appropriately on master copies of such SOPs as the case may be.
The above aspects should be clearly specified in the “Document Control”- SOP.
This is a general industry practice. There is no specific guideline on this aspect.

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5

Thanks so much sir.you have cleared all my doubts

6

You are always welcome.

1 Like
7

hi everyone , hope you are doing well
i have a question about acceptance criteria
is it preferable to mention acceptance criteria after each test is our SOP?
is there any mandatory guide about this in guidelines ? whether for mentioning or not mentioning acceptance criteria in our analytic SOPs

8

Good afternoon all sir, I would like to ask you, How to download the SOPs have on your website, Please reduce to me

Thanks