Building up a global quality management system

A

Aphel

Involved In Discussions
#1
#1
Dear all,

Has anyone experience in building up a global quality management system (starting point: zero) within a global acting company group, bringing a group of legal manufacturer sites under one QMS umbrella.

What are your experiences?
What are pitfalls?
what are do's and dont's?

Thank you in advance!
BR Aphel
 
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shimonv

shimonv

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#2
#2
Hi Aphel,
Since you are at a starting point zero, I would not advise to build a global quality system. It's a very big project and the effectiveness depends greatly on accumulated experience. There is something very appealing about one quality system, but it doesn't fit all situations.

The two biggest disadvantages (pitfalls) that I know off are:
1. Luck of flexibility at the various sites. Everybody needs to follow the same process.
2. Since processes run across sites, the review and approval usually takes longer.

Shimon
 
C

cferrer

Involved In Discussions
#3
#3
Just a quick comment on the fly:
I am currently leading the creation of a global system but we are not at zero. We have a combination of sister companies some of which are up and running, some are starting, some are already certified some are not. It is a challenge. The approach of having some common global elements shared by all companies with local specific elements is a good overall concept. Customization to your whole organization is key. Balance between rigidity and agility is also key.

There are some other threads that have dealt with this before. Even some in which I was looking for advice myself. Search around. If I have some time in the coming days (assuming you are still interested), I can share more ideas and we can discuss.

Cheers,
C
 
William55401

William55401

Involved In Discussions
#4
#4
Here are some things to think about.

Harmonize / standardize one QMS process at a time. Enabling IT systems (global application with same deployment at all sites) is a key success factor. In order of importance, focus on Complaints / MDR / Vigilance first. CAPA next. NC could be next but that often depends on the mfg execution systems (ERP) at the various sites.

Don't under estimate the resistance that sites can put up. Don't give in. A project like this will test your influence / leadership / change management skills. have fun
 
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