Procedures & PLM

I am working with a medical manufacturer to help them get into compliance with ISO13485.  Simply put, ISO13485 provides a list of procedures that you are to have in place.  These procedures are written documents so that you could be compliant without the use of software. Maintaining procedures is complicated enough without adding a person…

Maintaining Compliance…

Whether your company must comply with ISO9001, ISO13485 or other regulations, it is your responsibility to maintain compliance. I have knowledge of one company that, for one reason or another, did not maintain their compliance.  The ‘regulators’ pulled their license to sell their product.  They were not able to renew their compliance for 6 months. …

PLM in the Cloud or…

There are many ways to implement PLM software.  Your PLM software can be installed on a server within your company’s 4 walls, on a server in the ‘cloud’ or in some hybrid manner. When choosing PLM software, you will need a requirements document.  The first order of business is to perform a thorough analysis to…

The Last Mile for PLM

Oleg Shilovitsky posted a blog recently discussing the Last Mile – I will be describing my concept of the Last Mile. It got me thinking about how I see it relating to my PLM projects.  We all create a project plan to implement PLM solutions and schedule it to be finished at some time in…

Document Retention & PLM

It is important for an ISO audit that you have a document retention policy.  You must document all of your work and make sure that all documents are saved properly, secured [access controls] and backed up, etc.  When they look at a document, you must be able to show them how it got to this…

Scope Creep

A couple of weeks ago, I addressed the importance of your PLM requirements document. In that blog I did mention scope creep, but it deserves more attention. One result of your PLM requirements document should be a project plan. The project plan will have a time frame. Let’s assume for a moment that you did…

A Good Reason for PLM

John Stark posted a blog listing the ‘Top 10 business reasons for implementing PLM’.  While I agree with his reasons, I would like to emphasize the need to manage your engineering change process. A typical Engineering Change Control process might look like this: Someone writes up a change request and gives it to their manager.…