Should QA procedures be separate processes?

M

miriambnk

Hi all,

I'm new here, I've been reading posts for a couple of days and you all seem very helpful and knowledgable so I thought you might be able to help with a query I have.

I'm fairly new to ISO and QA in general, having been put in charge of getting ISO certification from May of this year. We initially had a consultant in who gave us some regurgitated versions of the 6 specified procedures and quality manual, which had no relevance to our company or what we actually do (we're a construction company so have to think outside the box for a lot of ISO matters as our 'product' is very different to manufacturing or service industries). I was appointed to carry this forward and have ended up having to completely rewrite a lot of our procedures as well as implementing a number of changes in our practice.

My question now is this: Should QA procedures, i.e. Customer Feedback, Document Control, Internal Audits, etc. be separate processes or is it sufficient that they are defined procedures within a wider process (currently Management for us)? Our original consultant just had Management as a process and everything else included as procedures within that which is how I've kept it for the moment, but I've been getting the impression from both training courses that I've attended and documents that I've read that this might not be the correct approach.

I'd appreciate any clarification anyone can offer me, I did have a search for previous discussions but couldn't find an answer.

Thanks in advance,

Miriam
 

qusys

Trusted Information Resource
Hi Miriam,
nice to meet you.
I think that the Cove is one of the best place to share ideas and info about Quality matters.
I will give my thought about what you asked for, but I also think the other experts can help you as well to find the correct direction.
You talked about QA procedures, in reality it could be not a proper definition, because the six procedures that you mention ( they are mandatory vs ISO 9001) belongs to the organization.
I should know more about your organization, but from what you reported it looks to me that the organization has not clearly established the QMS processes yet.
Probably the process approach, advocated in ISO 9001, has not been embodied by your organization yet.
My advice could be to fine tune well the core process of the QMS and then think about the procedures. Probably you are also referring to another level of procedures ( related to single process). In this case , you could assess these processes in order to undestand what it is still missing, basend upon the real needs ( I suggest a process mapping here).
Generally speaking, you should try to make your organization driven by QMS and not technology.
Hope this helps
 
A

anil123

Hi all,

I'm new here, I've been reading posts for a couple of days and you all seem very helpful and knowledgable so I thought you might be able to help with a query I have.

I'm fairly new to ISO and QA in general, having been put in charge of getting ISO certification from May of this year. We initially had a consultant in who gave us some regurgitated versions of the 6 specified procedures and quality manual, which had no relevance to our company or what we actually do (we're a construction company so have to think outside the box for a lot of ISO matters as our 'product' is very different to manufacturing or service industries). I was appointed to carry this forward and have ended up having to completely rewrite a lot of our procedures as well as implementing a number of changes in our practice.

My question now is this: Should QA procedures, i.e. Customer Feedback, Document Control, Internal Audits, etc. be separate processes or is it sufficient that they are defined procedures within a wider process (currently Management for us)? Our original consultant just had Management as a process and everything else included as procedures within that which is how I've kept it for the moment, but I've been getting the impression from both training courses that I've attended and documents that I've read that this might not be the correct approach.

I'd appreciate any clarification anyone can offer me, I did have a search for previous discussions but couldn't find an answer.

Thanks in advance,

Miriam

Hello,


Actually 1st step is to identify the process required to run the organization. Once you finalise it you have to document the same that how these processes will work. You will understand then that which procedure is required and which is not. I this this will serve the purpose
:agree:
 

SteelMaiden

Super Moderator
Trusted Information Resource
Welcome Miriam, we are glad to see you here, and hope that we can help you on your ISO journey.:bigwave:

First of all, construction is really not all that different from any manufacturing job, I used to be the design manager for a construction company. Sure your product doesn't get put in a cardboard box and loaded onto a UPS truck to ship it, but you still have a tangible product.

You are absolutely on track to create documentation that reflects who you are (as a company) and what you do instead of trying to force yourself into a mold that wasn't made for you. So, as stated, think about your entire process, and the steps/sub-processes that get you there and what happens during those steps, what info do you recieve, what do you do with it, what do you pass on to the next step? Keep on coming back and don't be shy about asking questions.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Welcome to the Cove!:bigwave:

Along with the really good responses I simply want to make two points:

1. Nothing dictates having a separate set of procedures for QA, or indeed even a QA department. I would resist an "expert" trying to shoehorn my organization into procedures that are not a good fit for use. The consultant's advice can be worked into what is already established, and in some cases the consultant's advice can even be rejected...as long as the standards' requirements are met, and of course your stakeholders' and customers'.

2. The move to break down "silos" and make Quality part of everyone's daily life invites an approach you already have: to address the subjects in management procedures.
:2cents:
 
J

John Martinez

Hi all,

My question now is this: Should QA procedures, i.e. Customer Feedback, Document Control, Internal Audits, etc. be separate processes or is it sufficient that they are defined procedures within a wider process (currently Management for us)? Our original consultant just had Management as a process and everything else included as procedures within that which is how I've kept it for the moment, but I've been getting the impression from both training courses that I've attended and documents that I've read that this might not be the correct approach.

Hi, Miriam. Welcome. I'm concerned that in your question you are confusing "process" with "procedure". If you do not have a copy of ISO 9000:2005 Quality Management Systems Fundamentals and vocabulary, I'd suggest you get one as these are defined in there.

If you are put in charge of this system, I'd first define the processes of your organization, then rebuild your system around that.

To answer your specific question, if you had a process that made sense to your organization that was "management" and it included management review, continual improvement, internal audits, corrective actions, preventative actions as sub processes, that would be acceptable.

Again, the above paragraph are processes of which three are required to have procedures. A procedure does not make a process in and of iteself.
 

Randy

Super Moderator
Do whatever works for you and don't woory about how others feel. In a case like this the only wrong way is the way that doesn't make the right things happen.
 
M

miriambnk

Thanks for all the responses :agree1:

We have defined our core business processes (i.e. purchasing, design, sales, etc.) and have identified management as a support process which incorporates all of the areas required by ISO, i.e. dealing with customer feedback and complaints, document and record control, internal audits, etc. as well as facilities/resources, training, etc. So I think we're covered from what you're all saying!

Thanks for the advice, I'm second guessing everything I'm doing at the moment as I'm worried about getting it 'wrong' but at the end of the day I want to implement ISO in a way which works for our business and actually improves the way we operate, not by adding a layer of bureaucracy that nobody cares about.

I'm sure there'll be more questions soon!

Miriam
 
A

anil123

Thanks for all the responses :agree1:

We have defined our core business processes (i.e. purchasing, design, sales, etc.) and have identified management as a support process which incorporates all of the areas required by ISO, i.e. dealing with customer feedback and complaints, document and record control, internal audits, etc. as well as facilities/resources, training, etc. So I think we're covered from what you're all saying!

Thanks for the advice, I'm second guessing everything I'm doing at the moment as I'm worried about getting it 'wrong' but at the end of the day I want to implement ISO in a way which works for our business and actually improves the way we operate, not by adding a layer of bureaucracy that nobody cares about.

I'm sure there'll be more questions soon!

Miriam

you are on the right track now
 
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