You may or may not have the same person managing Operations and QA

Jane's

Involved In Discussions
#1
Hi, if your employer is a small medical device manufacturer, you may or may not have the same person managing Operations and QA. How do you reconcile that situation with Section 5.5.1 of the standard.

Thanks in advance for your comments.

Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
My opinion -

It is a common mistake made by small organisations to place the QA function under Operations. QA can never be really independent in that situation, and typically commercial considerations will prevail. When the same person is in charge of both QA and Operations it becomes an internal/mental conflict, and QA will have a chance only if that person is coming from a very strong QA background, or is, alternatively, a saint ;)

I think that in order to properly fulfil its calling QA should be a completely separate entity answering only to the very top dog.
 
Last edited:

Golfman25

Trusted Information Resource
#4
It's kind of a silly problem. At some point the QA v. Production decision comes together into one individual. In a small company, whether it's the Production manager or the President, what is the difference.

We completely go rid of any distinction between Production and Quality. Everyone is responsible. They all work together to make good parts. We have very few "fights."
 

Ronen E

Problem Solver
Staff member
Moderator
#6
We completely go rid of any distinction between Production and Quality.
Great. That means no checks and balances.
Essentially Production is concerned with maximising throughputs and minimising costs. Typically, the easiest/quickest way to do that is to cut quality corners.
Good quality costs money.
Bad quality also costs money.
The issue is that the latter has much less visibility even though in the long run it has heavier bearing on business success, and it takes some vision among non-QA management to realise that.

Everyone is responsible.
So no one is responsible.
 

EthanLoh

Involved In Discussions
#7
I once had a client and he is the QA and Production manager. Normally, that will be a minor NC during audit. However he can proved his QA supervisors had the authorities to reject defectives products (with NCR reports) and these authorities are documented in the job descriptions.

It is undesirable to have QA and Production authority under the same person. However for small company, this a common fact.

It is all about documentation. :bigwave:
 

Ronen E

Problem Solver
Staff member
Moderator
#8
I once had a client and he is the QA and Production manager. Normally, that will be a minor NC during audit. However he can proved his QA supervisors had the authorities to reject defectives products (with NCR reports) and these authorities are documented in the job descriptions.

It is undesirable to have QA and Production authority under the same person. However for small company, this a common fact.

It is all about documentation. :bigwave:
It is the stuff that isn’t documented that matters most.

Of course they had documented authority to reject. The question is, how likely they’d be to exercise that authority when their boss (also the production boss) tells them (off-document) that they need to meet some production goals. Black and white is simple. The real challenge is when it comes to grey area decisions.
 

somashekar

Staff member
Super Moderator
#9
Great. That means no checks and balances.
Essentially Production is concerned with maximising throughputs and minimising costs. Typically, the easiest/quickest way to do that is to cut quality corners.
Good quality costs money.
Bad quality also costs money.
The issue is that the latter has much less visibility even though in the long run it has heavier bearing on business success, and it takes some vision among non-QA management to realise that.



So no one is responsible.
Quality is free. There is nothing like Good Quality / Bad Quality
It must be built in with optimization
Overdoing or under-doing will cost
 
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