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Where do I start when I Internal Audit the Quality Management System?

B

baby12

#1
Where do I start when I audit the quality management system? I mean, must I start with documentation or operation? (Audit Path)
 
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qusys

Trusted Information Resource
#2
Re: Auditing quality management system

where do i start when i Audit quality management system i mean must i start with documentation or operation?(Audit Path)
I guess you are dealing about an internal audit of your organization.
Quality Management System is the whole system that the organization has put in place. If you are performing an audit for each process of QMS you should examine inputs and ouputs of the audited process, documentation , training , tools, measurements, records, link with support process, I mean the turtle diagram approach:bigwave:
 

DannyK

Trusted Information Resource
#3
Re: Auditing quality management system

Begin with familiarizing yourself with the process. Read any procedures that are available and note any objective evidence requirements.
Refer to the standard that applies to the QMS and ensure that all requirements are being addressed.

The process approach is the most effective method for auditing as mentioned by qusys.
 

Raffy

Quite Involved in Discussions
#4
Hi :bigwave:
In our end, what I normally do from what I learned from my tutor is that I begin with the performance of the QMS, i.e. quality objectives.. If the quality objectives are met you might ask how to sustain such standing and/or improve from the current level to a much higher level. If the quality objectives are not met, then ask them, what is your corrective action for unmet goals...that could be a starting point to ask about their current process, competence of personnel, etc.
Hope this helps.
Best regards,
Raffy :cool:
 
T

Ted Schmitt

#5
I like starting from the point when my organization receives a quotation from our customers... how this quotation is answered, checked, and answered, hopefully then we´ll get an order .... how is this order checked with what was quoted....etc... factory capacity... can we make it in the customer needs... move on to Purchasing... did we have to buy anything for this order? Where the suppliers qualified? Move on to incoming inspection of raw material... records? inspected with what documents? Moving to production.... drawings? specs? machine capacity? Operator capacity? Assembly... specs? Assembly instructions? Final inspection? Packaging? Transport? Shipping?
That cycle finished... how did the customer receive his order? was he happy? is he going to buy again?
Alot of this info will feed Management Review which you can audit at the end...

There are alot of points (4.2.3 / 4.2.4 / 7.6 / and a bunch more) which i left out during the whole process but it´s to give you an idea of how I like to audit...

Auditing this way, I get a feel of the process approach in an organization...

Hope this helps...
 

qusys

Trusted Information Resource
#6
I like starting from the point when my organization receives a quotation from our customers... how this quotation is answered, checked, and answered, hopefully then we´ll get an order .... how is this order checked with what was quoted....etc... factory capacity... can we make it in the customer needs... move on to Purchasing... did we have to buy anything for this order? Where the suppliers qualified? Move on to incoming inspection of raw material... records? inspected with what documents? Moving to production.... drawings? specs? machine capacity? Operator capacity? Assembly... specs? Assembly instructions? Final inspection? Packaging? Transport? Shipping?
That cycle finished... how did the customer receive his order? was he happy? is he going to buy again?
Alot of this info will feed Management Review which you can audit at the end...

There are alot of points (4.2.3 / 4.2.4 / 7.6 / and a bunch more) which i left out during the whole process but it´s to give you an idea of how I like to audit...

Auditing this way, I get a feel of the process approach in an organization...

Hope this helps...
If you also customize this approach for a specific product, you will have the trail for the product audit requested from ISO TS . I agree with what you said in the last sentence, that this approach helps to have the pulse of how much the process approach is real in the QMS of the audited organization. Most of times the issues are in folds of an organization, in the so-called grey areas between two different processes.:bigwave:
 
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#7
Where do I start when I audit the quality management system? I mean, must I start with documentation or operation? (Audit Path)
Can we assume that you've had some kind of auditor training? If so, then the next step is to determine what the scope of the audit, criteria and objectives are. Before you determine anything more about reading documentation etc, you must have these items identified. Others have waded in with their ideas about starting what appears to be a system wide audit (much like a CB audit) but until we have knowledge of the scope and criteria and why you are doing the audit. Please let us know what those are and then we can give you much more helpful feedback on where to start...
 

sagai

Quite Involved in Discussions
#8
type in browser: google.com
type into the search field: iso 19011
and check the first link given.

:popcorn:
Sz.

Aaaandyyy --- :lmao:
 
D

darkopsghost

#9
All of what has been posted above is the same methodology that I have used; start at the beginning and work all the way to the end, including Management Review, both at the beginning of the process all the way to the end resultant; was the customer happy?

Think of the items that you were asked during the last audits, whether Customer, Prime, or Registrar Audits.

Also, don't forget to look at findings from previous audits, either internal or other. Check this area, to see if your findings and your corrective actions were correct and further more correct.
 
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