Tips for a first Process Audit on the QMS system at a new company

yehardeb1

Starting to get Involved
#1
Hi,
In a general sense - has anyone got tips for a first process audit on the QMS system at a new company?
Important criteria to check? KPI? Continual Improvement effectiveness? pitfalls to watch out for?

Sorry for being general - new employee to a company just want to make sure im not missing anything......

:thanx: in advance........
 
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D

Duke Okes

#2
Re: QMS Audit

Hi,
In a general sense - has anyone got tips for a first process audit on the QMS system at a new company?Important criteria to check? KPI? Continual Improvement effectiveness? pitfalls to watch out for?Sorry for being general - new employee to a company just want to make sure im not missing anything......
:thanx: in advance........
1. Does the documented QMS meet external requirements (e.g., ISO 9001 or other standards, plus customer-specific/contractual requirements)?

2. Are the defined/documented processes being followed?

3. Are the processes meeting objectives?

4. When processes don't meet objectives, is appropriate action being taken and is that action effective?

5. When objectives are being met are opportunities/needs for improvement being defined, and actions taken to address them?
 

Stijloor

Staff member
Super Moderator
#3
Re: QMS Audit

Hi,
In a general sense - has anyone got tips for a first process audit on the QMS system at a new company?
Important criteria to check? KPI? Continual Improvement effectiveness? pitfalls to watch out for?

Sorry for being general - new employee to a company just want to make sure im not missing anything......

:thanx: in advance........
Welcome to The Cove Forums! :bigwave: :bigwave:

Have you been trained (and deemed competent) as an internal auditor?
The training includes a section about how to prepare for a(n) (process) audit.

Also, there are many great threads and posts about internal auditing here.
Have you searched?

Stijloor.
 

yehardeb1

Starting to get Involved
#4
Re: QMS Audit

Hi and thanks for the welcome :) - i am deemed competent as an internal auditor (main area of expertise however is NC's - RC analysis and CAPA) - but now moved into a brand new industry therefore one of my initial goals is to perform a general audit of the QMS system - i havent had much exposure to this forum but it looks a great resource for information that i will duly explore......
just looking for quick tips and obvious pitfalls in the general sense
 
#5
Re: QMS Audit

Hi and thanks for the welcome :) - i am deemed competent as an internal auditor (main area of expertise however is NC's - RC analysis and CAPA) - but now moved into a brand new industry therefore one of my initial goals is to perform a general audit of the QMS system - i havent had much exposure to this forum but it looks a great resource for information that i will duly explore......
just looking for quick tips and obvious pitfalls in the general sense
Good advice and question so far, and we hope you'll come back for/with more.

I'm interested in you statement on being 'deemed competent', but not in any process requirements (only what appears to be what happens when things go wrong)! For example, my competencies lie in design/manufacture of light mechanical assemblies, electronics etc. To know about 'nc's and the actions after, would also have to include the process that caused them, IMHO - otherwise it's difficult to know if the fix has even half a chance!

Tell us more about your experiences and what kind of industry you're in now.

BTW there have been score of really good discussions around getting started with auditing. Welcome, again - from an ex-pat!
 
D

DrM2u

#6
Re: QMS Audit

Hi and thanks for the welcome :) - i am deemed competent as an internal auditor (main area of expertise however is NC's - RC analysis and CAPA) - but now moved into a brand new industry therefore one of my initial goals is to perform a general audit of the QMS system - i havent had much exposure to this forum but it looks a great resource for information that i will duly explore......
just looking for quick tips and obvious pitfalls in the general sense
My (good, bad or indiferent) approach would be:
- review the quality manual, specifically the scope and the process interraction diagram(s); this way I can get a good understanding of what the organization doeas and a good picture of the processes employed by the organization
- follow the major product realization process(es) step by step and sample each; this way I can see and record the actual process, the process & product performance monitoring, documentation, records, employees, gages, materials, equipment & environment; I can also ensure that the interractions are as described in the quality manual
- from here I can follow up on support processes like calibration, maintenance, purchasing, training, document & record control, quality planning, engineering, NC product control, etc.
- after I review all these processes I would look at customer satisfaction and business planning ; this is the evidence of management's commitment to meet customers' requirements and meet the requirements of the standard
- after I finish reviewing all these processes I would take any questions and collected performance indicators and look at data analysis, internal audits, management review and improvement actions system for actions to address any previously identified nonconformances and opportunities; this will evidence the support and commitment from the management to implement, monitor & maintain the QMS, and to continually improve.

Note that the last two bullet points more or less reflect the requirements for an organization's quality policy. By following this approach to auditing I can get a very good picture of any organization that I can expand on as needed. If you are consulting, then use the findings to formulate your proposal to the organization; this way you will be very close to the actual amount of time and effort you have to trade for the quoted price.
 
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