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
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
shimonv

shimonv

Trusted Information Resource
#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

Quite 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
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A Building up a global quality management system ISO 13485:2016 - Medical Device Quality Management Systems 2
JAMESH Building a "Lean" Job Shop Training Program Training - Internal, External, Online and Distance Learning 0
DuncanGibbons FAA's Building Block approach to certification Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
John Broomfield Informational Chartered Institute of Building - Code on Quality Management Service Industry Specific Topics 2
J Facilities - Placing our assembly group into a separate building ISO 13485:2016 - Medical Device Quality Management Systems 8
T FAI (First Article Inspection) of Large Assemblies/Tooling after move to new building AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
A Process moved to new building - Now we are in trouble IATF 16949 - Automotive Quality Systems Standard 8
M Building Production / Manufacturing Facility for Class 2 Medical Device US Food and Drug Administration (FDA) 1
H Two Business Units Combined in the same Building ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
L Building your own Leakage Current Tester IEC60990 Other US Medical Device Regulations 4
C Acceleration Calculation - Building Vibration Requirements Misc. Quality Assurance and Business Systems Related Topics 3
R How much Protective Current Rating of Building Branch Circuit should be considered? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Building Heavy Pollution Factory next to Medical Device Factory (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 6
S Building and Warehouse requirements of OHSAS 18001 Occupational Health & Safety Management Standards 8
C Building a Dimensional Metrology Laboratory to Inspect various Physical Measurements General Measurement Device and Calibration Topics 2
M System Building - What are the key steps? Quality Manager and Management Related Issues 2
M Building an AS9100 QMS (Quality Management System) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
B Building a Class 10,000 Clean Room Manufacturing and Related Processes 2
P Specifying the building of a new Calibration Laboratory General Measurement Device and Calibration Topics 6
P Heavy Manufacturing Supplier QA - Building Units at a Supplier's Facility Supplier Quality Assurance and other Supplier Issues 1
R Building an OEE System to our Production Lines - New concepts to me Lean in Manufacturing and Service Industries 12
Marc Green Building: A Real Estate Revolution? University Of Michigan Banks On LEED Sustainability, Green Initiatives and Ecology 1
E Building a Calibration Room Test Bench - Finding components, test leads, etc. General Measurement Device and Calibration Topics 8
J Building the QMS (Quality Management System): Getting Started Document Control Systems, Procedures, Forms and Templates 16
T Inspection Records for a Building Contracting Firm Service Industry Specific Topics 1
B Get design from outside. Is it an outsourced process? Ship Building ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Customer Care - Building relationships to acquire, satisfy and retain customers Customer and Company Specific Requirements 2
Marc World's largest building struck by lightning - The Burj Khalifa World News 3
DanteCaspian Recommended Andons? Building 3 light-4 light andons, with or without sound Lean in Manufacturing and Service Industries 8
C Long Term Risk of Building without full set of Released Drawings Design and Development of Products and Processes 2
P Quality control system in building sites - Construction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Building a Database for Equipment Failures Document Control Systems, Procedures, Forms and Templates 9
hogheavenfarm Extent of certification - Companies sharing manufacturing space in a building ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Leak Test - Building a master pump to calibrate pump tester Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Is 6 sigma suitable for ship building where the nature of work is non repetitive? Six Sigma 12
Antonio Vieira Requirement 7.3 Exclusion - Building Construction Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Y Outdoor and Indoor Team Building Program Suggestions Training - Internal, External, Online and Distance Learning 1
J Product Realization Plant Layout - Moving to a Larger Building - Need info Manufacturing and Related Processes 7
B PFMEA Risk Assessment - Transfer of Production to a New Building (Relocation) FMEA and Control Plans 9
H How to Start Building New Management System for OHSAS 18001 and to Start Implementing Occupational Health & Safety Management Standards 10
M Defining the Problem and Building Experience - For Discussion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Building a Balanced Scorecard The Reading Room 11
S Visual Inspection Variation - What can we do? Building slot machines Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
C Quality Plan in a Service Company - Civil engineering service - Building construction Service Industry Specific Topics 4
C Building a Home and Cost of Poor Quality Coffee Break and Water Cooler Discussions 14
M What are all the possible building blocks or inputs for a process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Y ISO applied Information - Building the organization effectively ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Y Team Building Exercise - Training that boosts group motivation level Misc. Quality Assurance and Business Systems Related Topics 2
I Building a new cleanroom - ISO 14644-3 or ISO 14644-4 ISO 13485:2016 - Medical Device Quality Management Systems 4
R Designing and building our own machines Design and Development of Products and Processes 5

Similar threads

Top Bottom