Quality Assurance Procedures vs. Standard Operating Procedures

  • Thread starter Rajesh Anantharaman
  • Start date
G

Greg B

#11
Do whatever you want;

Call things whatever you want;

It doesn't really matter what you call them or what you do with them as long as you meet the requirements of 4.2.3 and 4.2.4.


Worry and fret over the really important stuff like actually doing it.

Everything else is dribble.
I only read this thread because I saw that Randy had replied. He has the perfect answer, as usual. Keep it Simple! It is after all YOUR business so do what you want.
 
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R

Rajesh Anantharaman

#12
Okay..I just got the news that all QAPs should be converted to SOPs to avoid confusion for everyone in the company as well as any and all external auditors.

Somehow it just makes sense to me now that this should have been done in the first place :frust:
 

Wes Bucey

Quite Involved in Discussions
#13
Okay..I just got the news that all QAPs should be converted to SOPs to avoid confusion for everyone in the company as well as any and all external auditors.

Somehow it just makes sense to me now that this should have been done in the first place :frust:
"news" from whom? I don't know this to be true or even a common practice. I have a strong suspicion some of the folks making these "decisions" are pulling comments out of context in someone's treatise on Quality Management Systems without any sense of "big picture" vis a vis harmonizing a QMS with a Standard like ISO 13485.

Many organizations have multiple types of documents with no confusion -why should the folks at YOUR organization become confused?
 

Jim Wynne

Staff member
Admin
#14
I have a strong suspicion some of the folks making these "decisions" are pulling comments out of context...
I have to agree, only I don't think that's where they were pulling comments out of, if you'll excuse my grammar. :D

Many organizations have multiple types of documents with no confusion -why should the folks at YOUR organization become confused?
:agree1:I wish everyone would spend a lot less time worrying about what documents are called, and a lot more worrying about what they say.
 
R

Rajesh Anantharaman

#15
We had a meeting regarding what to call the Procedures (QAP's or SOP's). The person making the decision seemed highly confused when i told her some are QAP's and some are SOP's. She wanted them to be consistent as SOP's since both QAP and SOP is telling a person what to do, how to do and what to use. The person i keep referring to is the company founder, who has quite a bit of Quality knowledge dealing with other companies and auditors in the past.

Thankfully for me, the format for both QAP and SOP is the same in this company and hence all I have to do is to change the Header and Footer and change the Title from "Doc 8.2.1 - Inspection and Testing" to "SOP M-0XX - Inspection and Testing"

Sounds reasonable??
 
G

Greg B

#16
We had a meeting regarding what to call the Procedures (QAP's or SOP's). The person making the decision seemed highly confused when i told her some are QAP's and some are SOP's. She wanted them to be consistent as SOP's since both QAP and SOP is telling a person what to do, how to do and what to use. The person i keep referring to is the company founder, who has quite a bit of Quality knowledge dealing with other companies and auditors in the past.

Thankfully for me, the format for both QAP and SOP is the same in this company and hence all I have to do is to change the Header and Footer and change the Title from "Doc 8.2.1 - Inspection and Testing" to "SOP M-0XX - Inspection and Testing"

Sounds reasonable??
This sounds perfect!!
 
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