Release Authorization - Does the authorization have to be from quality? Clause 8.2.4

K
#1
Question: Does the person authorizing release have to be from the Quality Department? My boss is trying to convince me that this is an ISO requirement (shows how much he knows), that's a non-starter. In some cases I see the people doing the test (Production, Software etc.) being the releasing authority. How do the rest of you handle this?
 
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Mike S.

Happy to be Alive
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#2
Ken,

Just my opinion, but I think the standard will allow someone from ANY "department" to authorize release of product (basically, give final approval for shipment) IF that person is deemed capable/competent and he/she has been formally authorized as specified in your procedures.

At our company, I say a "QA Department Representative" must authorize release of product. Some of these folks are actually "QA Department" employees but most are considered primarily "Manufacturing Department" or "Engineering Department" people whom I have trained and I trust to do the right things and make the right decisions -- i.e. they "represent" the QA Department in these decisions. When it comes to quality issues, I am their boss as far as what rules/procedures they must follow even though I am not their direct Manager, and I am ultimately responsible for their decisions. Our customers are okay with this. Does this make sense?
 
#3
Okay...I'll bite!

Ken, My first question is always: "What does the standard say?" There are some organizations out there (including manufacturing) that have no official "quality department", nor "quality inspectors" (I personally think we should abolish ‘quality’ functions and place the responsibility where it belongs). In these circumstances, the companies would have to add a level of bureaucracy just to meet the standard. Politely, and with all political correctness, ask your boss to “show you the shall”.
 

RoxaneB

Super Moderator
Super Moderator
#4
My organization uses a matrix (no surprise to some of you by now, I'm sure! ;) ) to show who can allow material(s) to enter their area and who can allow material(s) to leave their areas. We account for all key product (not just finished product) on our property.

Finished product can not even leave the site without a disposition certificate (we are legally required to state that our product meets specs and grade) from our QC Superintendent - the person who is responsible for ensuring that all is in order, however, is our Shipping Superintendent.
 

E Wall

Just Me!
Super Moderator
#5
KenS:
Depending on your business you will usually have different levels of monitoring and measurement. Ideally this should go hand-in-hand with your process control plan (where critical characteristics as well as who is responsible for checking them) that is already established.

Even final product must meet established criteria, so whoever you have authorized to evaluate those characteristics should be qualified to release the product as well.

We had one customer that had required Quality Certificates with each shipment, and those were done based on test performed by the Quality Department so the QA Manager had sign-off/release.

Eileen
 
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