Quality assurance

[former_member223028]

dear experts

1.How we can map Quality assurance in QM module

2..Any difference is there with quality assurance and QM module

3.QA is a seperate module in SAP?

Please give me some details answer

AF

[Former Member · Accepted solution]

Hi

"Quality Assurance" can not be termed as a module actually. It is a terminology used as a next level to Quality Control. So, QA is nothing but ensuring the quality of a product/service at all levels and at all aspects. Again it depends upon your company policies and standard operationg procedures to what level QA is required. QM module covers most of the QA aspects dependin on your company policies like for few examples: Source inspection, incoming inspection, inprocess inspection, Inspection at GR, Inspection at delivery, Stability study, control charts, trend analysis, vendor analysis, QM notifications with CA & PA. etc...

So here you need to define which are the things to implement & which are not.

Thanks

Sachin

[former_member42743]

QA typically has come from the pharma world.  Most people outside of Pharma tend to misuse the term QA.  QA groups in Pharma do not usually manage master data in SAP.  They do not do product quality checks.  In fact they rarely even touch the product.

QC groups are responsible for testing, analyzing, maybe sampling, but in some Pharmas even that is a separate group.  QC or a specific master data group are responsible for QM master data.  QM is simple the term SAP used to call their quality module.

QA groups are primarily tasked with verifying and ensuring adherence to company SOP's, policies and procedure.  They usually review all the final paperwork on drug product.  Make sure all analytical data has been properly recorded, signed off, reviewed and signed off again.  I.e. they don't determine that a particular result is good or bad. They don't really care in that sense.  Thy care that a proper sampling procedure was followed, samples were traceable to a particular result, testing was done in accordance with the method, personnel used to do the testing were trained to perform the test, qualified people reviewed the result, test equipment being used was properly cleaned, setup, used valid standards, etc.. etc.

Think of QA as your internal auditors almost.  In some places QA actually follow QC personnel around while testing is ongoing and they may countersign off on say a sampling sheet used to draw sample to indicate they witnessed the sampling and it was done according to procedure. 

So in the end, a QA group assures that whatever result is obtained, good, bad or indeterminate, the result is valid.

In SAP some job functions may be included in the blueprint.  QA might in fact be the only people allowed to make a UD and post certain products to unrestricted inventory. Since they have to review paperwork before release this might be their job.  SAP has an electronic batch record functionality in SAP.  QA would usually have responsibility to approve the batch record in the end.

FF

[Former Member]

Hi Quality assuarance is not different from QM module. Only in  business scenario they call the quality department as quality assuarance. Basically they do the inspection and quality planning. So it ll be the standard module only. There is no separate module in SAP as QA.

Smruti