Big companies suffer from quality management system?

Developer_Germany

Starting to get Involved
#1
Big companies often have a variety of different product types, internal departments, internal processes and many many people involved. Thus, the quality management system is often so big and complex that product ideas will never reach the market or after a so long time that any innovation is killed.
What are your principle concepts and ideas to make quality management systems in big companies really lean?

Here are some examples from me:
- break up large structures into small units with their own, self-sufficient QMS
- completely outsource development and production and work via supplier monitoring
- less content in process descriptions and work instructions. Thus more freedom is achieved within product realization projects. Regulatory compliance is therefore more likely to be represented by development plans than by the procedural instructions in the QMS
 

William55401

Quite Involved in Discussions
#2
Here's my first quick take. I am assuming you are talking about a multi-site, multi-national, and multiple product types organization. When I think about lean in a MNC, it is about how do you create standard work and leverage the scale. I agree that certain processes will be unique like product development. Software only will be different from hardware will be different from software integrated into hardware. Does the company create their EBIT from mfg volume? Is mfg a core competency? Then do alot of it. If not, then outsource it.

Areas to scale (standardize) across the enterprise via software include Complaints, CAPA, and the Purchasing process (to leverage spend and manage supplier risk consistently).

There is no one size fits all solution. A key part of a MNC is integrating new / acquired businesses to leverage the scale.

Procedures need detail to maintain compliance. In an MNC, you will have specialist that will rely on detailed WI. Open ended / simple block diagram procedures have compliance risk.

One more. I am not a fan of many small QMS. Alignment from site to site can be challenging. It can hinder product transfers on the make side. It creates maintenance costs via hosting Notified Body audits and the like and having more documents to maintain from many sites. How many CAPA and complaint procedures do you really need if everyone is on the same enterprise e solution?.

Most MNCs have a "One (insert company name)" project to get aligned to what makes sense for their org. Gotta run. HTH. Have fun.
 
Last edited:
Thread starter Similar threads Forum Replies Date
K IoT, AI, Big Data and National Strategies of Other Countries (in your country, do you have any?) IEC 27001 - Information Security Management Systems (ISMS) 12
Ninja Getting eaten by Big Business - My company was bought by a huge multinational Coffee Break and Water Cooler Discussions 54
A Demonstration Test Plan for Reliability of Big Equipment Reliability Analysis - Predictions, Testing and Standards 5
J What's the big picture on Notified Bodies? EU Medical Device Regulations 4
H Interesting Article:Weak Supplier Relations Costing Big 3 Automakers, Nissan Billions World News 4
L Continental Automotive (or any other big German OEM) APQP list wanted VDA Standards - Germany's Automotive Standards 5
A VSM: Between OP1 and OP2 there is a big conveyor. How to represent that on VSM?? Lean in Manufacturing and Service Industries 6
Q ISO 9001 - 3 BIG questions to help a Newbie's Sanity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Electrical Surgical Tool with Big Metal Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Setup Time Reduction Project - How big should my team be? Six Sigma 2
AnaMariaVR2 Big Tobacco Lawyers going after Big Food US Food and Drug Administration (FDA) 1
AnaMariaVR2 Big Data The Reading Room 4
1 A New Job - Replaced a QM who passed away - BIG Problems Quality Manager and Management Related Issues 25
R Ppk vs Cpk: Big Differences - What conclusion can I reach about my process? Six Sigma 3
F ISO 9001 Certification for a Big Government Entity - One Certificate for each Dept.? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
T The best way to pull some meaningful stats from a really big project? Using Minitab Software 3
S How big is your Medical Device Technical File? CE Marking (Conformité Européene) / CB Scheme 3
Manix Engaging 'Big' Suppliers in Quality Improvement Supplier Quality Assurance and other Supplier Issues 3
A When a Company is Too Big for Quality Service Industry Specific Topics 20
A How Big/How Small - Size limitation on a company being ISO 9001 certified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
AnaMariaVR2 3 Regulations that Could Have a Big Bearing on Pharma in 2011 US Food and Drug Administration (FDA) 0
T Big problems with Inspection - Manual Operation - Needs experts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 27
M Gage R&R for Big Parts - Approving a Variable Gage using only 1 Part Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
N G8D (the form) - No one will want to use a big, long form Problem Solving, Root Cause Fault and Failure Analysis 7
Marc Microsoft Losing Big To Apple On Campus After Work and Weekend Discussion Topics 18
Marc Google Bargains Away Net Neutrality - Big Business Winning After Work and Weekend Discussion Topics 1
Stijloor "Big Brother" Google? World News 1
M ISO 29001 Certification Industry - How big and who are the players? Other ISO and International Standards and European Regulations 2
G First time flyer - My big concern other than crashing is air sickness! Coffee Break and Water Cooler Discussions 41
J Internal Audit Teams - How big the audit team should be and who should be on it General Auditing Discussions 6
A The ?Big D? (aka Dallas, TX) becomes the ?Green D? Other ISO and International Standards and European Regulations 3
T The "Big Three" can do something right! World News 11
S The Big 3 - Customer Specific Requirements Customer and Company Specific Requirements 6
Marc The end of the road for U.S. carmakers? Are the Big Three worth saving? World News 27
R Can I use Nonparametric Method to big samples? Statistical Analysis Tools, Techniques and SPC 22
Wes Bucey Big Brother! - Even in your color laser printer After Work and Weekend Discussion Topics 15
U SPC, The Big Picture Statistical Analysis Tools, Techniques and SPC 10
Stijloor ASQ's (American Society for Quality) Next Big Thing...... ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 16
C Gutting the Control Plan of all details and and getting it accepted by the big 3 FMEA and Control Plans 11
H Big Batch (Large Lot) Sampling - Label Printing - MIL-STD-105E Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
J Auditor training - Is there a big difference between auditing ISO 13485 & ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 8
A My Company wants to Implement ISO 9001-2000 and become Certified - The Big Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
ScottK Local Community Message Board - Big Brother? Coffee Break and Water Cooler Discussions 18
ScottK Is using a 3rd party auditor for supplier audits a big trend? Supplier Quality Assurance and other Supplier Issues 14
Marc Big Three get March 2007 U.S. sales beating, Toyota cheers World News 0
L Big Shipping Error - Shipped without the CE mark on them - Need advice! CE Marking (Conformité Européene) / CB Scheme 5
D Big *ss Fans World News 6
J BIG 3 customer asks us - Will TS 16949 make you more effiecient? IATF 16949 - Automotive Quality Systems Standard 4
O PPAP Process Map - Does anyone map out the PPAP process for the Big Three? Process Maps, Process Mapping and Turtle Diagrams 2
Marc Detroit's Big Three seek White House help World News 6

Similar threads

Top Bottom