Employees perceive CAPA as Bad - How to cope with the situation

[QE]

Probably I need to work for that GM, because the Class III Medical Device Manufacturer I work for Sucks Big time, and there are no jobs out there to make a switch. It seems like economy is slow and Quality Department is to blame. What a shame.

[JaneB]

In Reply to Parent Post by QE

It seems like economy is slow and Quality Department is to blame.

My heavens, but the Quality Department has some incredible power then!

[QE]

QE's Hands are tied. Quality managers dont allow to do any thing.

[Randy]

In Reply to Parent Post by QE

QE's Hands are tied. Quality managers dont allow to do any thing.

That's because 999 times out of 1,000 Quality is looked at and managed as a cost instead of an investment therefore return is never realized.... More often that not it's a self inflicted wound that starts with whoever is in charge of Quality because their focus is on stats and not finance.

[QE]

Randy,

Thanks for the feedback so I guess I have lost my belief from the Quality System. There is only one system and thats business system. Any program managers jobs out there ?

[MIREGMGR]

In Reply to Parent Post by QE

The company I work for (class III) sees and perceives CAPAs as a bad thing.

Presumably your CAPA program is only used for Corrections and Preventions. Both of these usually originate with an auditor or customer identifying something that's being done wrong.

Start to also use it for those Improvements that are more benignly based, i.e. a good suggestion to improve product conformance or to make some other improvement that the current specs don't control optimally, or maybe an opportunity to decrease costs, or some other improvement. If that idea doesn't get across without a new name, call them CAPAIAs.

Keep a score each quarter for the department, or production sub-department, that's closed out the most CAPAIAs. Give out some kind of tangible reward...maybe a piece of candy. Keep a log of quarterly winners.

[John Broomfield]

In Reply to Parent Post by QE

The company I work for (class III) sees and perceives CAPAs as a bad thing.

The program managers can not plan around it as they have no control over it and there is some reactive data streams that they are totally aware of. Can my fellow members at cove advise me how to operate in this environment ? How CAPA's are perceived in other places. is it a time for me to start looking around at this point ?

QE.

QE,

Sounds like you work in a blame culture. Blame creates fear and loathing of reporting a potential nonconformity for PA and reporting actual nonconformity for CA. Hopefully PA comes before you have to do CA!

Can you hold a one-day workshop for the leaders so they understand and can explain that their system is meant to help people to determine and fulfill requirements? Where their system fails to help people to determine and fulfill a requirement they need to fix their system. They also need to understand the damage they do by blaming employees for nonconformities caused by their system.

Their mantra should be "the only bad nonconformity is the one we do not know about". And "think not what you can do for our system but what our system can do for you".

I wish you well in ridding your organization of blame culture. it could take a few years!

John

[Randy]

In Reply to Parent Post by QE

Randy,

Thanks for the feedback so I guess I have lost my belief from the Quality System. There is only one system and thats business system. Any program managers jobs out there ?

If you've been managing a QMS or have been an MR you've been doing Program Management.

You're just in a rut, turn the negative stuff into positive, it's just perpective and attitude. When surrounded by Chinese troops during the Korean War, Chesty Puller said and I'll paraphrase "simplifies the problem, we can shoot in any direction now". Figure out a way to break the problem down into its simple parts and go after each one seperately.