How to be more efficient in Medical Device QA and save money?

sagai

Quite Involved in Discussions
#11
sorry, one more question, does it mean you are not creating, reviewing or approving the production related part of the QM system?
Regards
 
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S

SteveK

#12
sorry, one more question, does it mean you are not creating, reviewing or approving the production related part of the QM system?
Regards
I wrote the QM system! Within the audit I am ensuring that Production comply with all the relevant procedures (SOPs) or sections of in actual practice i.e. if it indicates that a serial number is generated in such a manner - then that is done as written - with examples, not generated by other means. As I said the external auditor was OK with this approach. Obviously procedures etc can develop/change - but as the QM I should be the first person to be told of any new proposals!

Steve
 

sagai

Quite Involved in Discussions
#13
Sorry for hanging on it, but I would like to understand and actually I have a more or less similar situation.

When you wrote the QMS, how can you be sure that you can identify your own mistakes in the course of the internal audit?
I understand you can audit the implementation of the QMS (real life follows or not the SOPs, however I would raise question of the effectiveness on the implementation, anyway its a completely different subject, sorry), I am okay with that.
Thank you
Sz.
 
S

SteveK

#14
Sorry for hanging on it, but I would like to understand and actually I have a more or less similar situation.

When you wrote the QMS, how can you be sure that you can identify your own mistakes in the course of the internal audit?
I understand you can audit the implementation of the QMS (real life follows or not the SOPs, however I would raise question of the effectiveness on the implementation, anyway its a completely different subject, sorry), I am okay with that.
Thank you
Sz.
Good point about checking your own mistakes – difficult area, nobody is perfect! With respect to internal auditing what has been done by the auditor (and me) is that at least for procedures, they are gone through with the nominal ‘owner’ line by line. Example for the Purchasing SOP “so Mr. Purchasing Manager is this what you actually do; do you send out supplier questionnaire form xyz on an annual basis or is it biannually etc etc”? As to the other tiers in the QMS the MD signs off the Quality Manual (and procedures), for Work Instructions you check with the operators etc "do you use gizzmo A when assembling widget B" - e.g. if you know there has been a design change etc. You have to rely on good communication to some extent and constant checking of the system. Hopefully the internal audit will then pick up on the fact that there has been some poor communication in some areas since the last audit etc leading to a NC.

Steve
 
C

CBAL08

#15
Was nice reading through the discussion in this topic. Having worked for a company ( similar to SteveK less people and small) I sometiems face the similar problem of evaluating the QMs efficieny?
This question is for SteveK-Regarding the Intrenal audits we often do a full audit once a year. However the Auditor suggested that we can rather do an Internal audit based on our Focus area- by this i was confused- do not know what he meant by this ? Did he mean that we can only do Intenal audits for Design and development process sometiems in June ( just and example) and Purchaing process in Octiber?) Please help. Or do we do a Risk analysis / Gap analysis and base our Audit schedule on that? Would be great to hear your thoughts as I am having problem scheduling the Internal Audits.
 
S

SteveK

#16
Was nice reading through the discussion in this topic. Having worked for a company ( similar to SteveK less people and small) I sometiems face the similar problem of evaluating the QMs efficieny?
This question is for SteveK-Regarding the Intrenal audits we often do a full audit once a year. However the Auditor suggested that we can rather do an Internal audit based on our Focus area- by this i was confused- do not know what he meant by this ? Did he mean that we can only do Intenal audits for Design and development process sometiems in June ( just and example) and Purchaing process in Octiber?) Please help. Or do we do a Risk analysis / Gap analysis and base our Audit schedule on that? Would be great to hear your thoughts as I am having problem scheduling the Internal Audits.
Without getting into the mind of the auditor (probably not a good idea!), your indication of audit scheduling certain areas/departments over a time period may well be what he/she meant – i.e. some type of matrix approach. From the information from the Cove etc, I believe this is how larger companies conduct audits – basically they would have no option. I’m certain companies like J&J, GE Healthcare and Siemens etc would not plan to do a full internal audit in a day or two like we do – with one IA and one QM! I guess it does not really matter how the IA is done so long as it is completed before the external audit. Don’t know if this helps.

Steve
 
T

The Specialist

#17
This is a tricky one! May I suggest...

...e.g. the customer orders the wrong item (Sales Department), [/QUOTE]
Teach customers how to read.

they have tampered with a device (Customer),
Cut off customers' fingers

our courier decides to have a head on crash thus causing some transit damage (Production/Dispatch),
Courier needs counselling...'Deciding' to crash is not normal behaviour

item costs too much (Purchasing Department),
Accept alternative currency, e.g. Cucumbers

customer does not like the colour of the device (Design Department)
Convince customer he is colour-blind and that everyone else will love it.

or they were overcharged (Accounts).
Pay refunds from newly acquired Cucumber stock-pile.



I think that just about covers it!

(it is 16:11 on a friday here!)
 
C

CBAL08

#18
Thank you SteveK. I was use to doing the full audit as it seemed to be possible and OK for small companies like ours. However the Auditor seems to think that its time consuming and does not have to be that way. They are concerned about focusing on the Focus areas rather than full audits.

That is why wnatde to look up for some ideas and suggestion in the cove.

Thank you once agin SteveK for your feedback.:thanx:
 
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