Big companies suffer from quality management system?


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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
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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.
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