Come up with a solution to our CAPA system

[goldcoastwestie]

Hi everyone - this is my first post, I have been an avid viewer for a while.

I work for a smallish company 32 employees in the Design and Manufacturing industry.

We are ISO9001:2008 compliant. We have our CEO who is the QM, but really he has no interest. I am the 'lead' internal Auditor and have been involved in this for about 12 years.

We are trying to come up with a solution to our CAPA system. Currently we have a central box with Problem Notification Forms which staff can complete. The box gets checked daily and our Customer Service Manager reviews and records them on to a controlled spreadsheet. Anything urgent is addressed there and then, but anything deemed non-urgent is placed in a 'pending' tray for review by the QM.
The QM is not pro-active in reviewing these so they just sit there...waiting and waiting.

Just wondering what systems other Manufacturing companies use out of interest, and would it be prudent for our team of 3 auditors to get together to review them?

Any assistance would be appreciated. Thanks

 

[Jen Kirley]

Re: CAPA

Welcome to the Cove!

I take it these are nonconformances issued by the three auditors?

There have been other discussions about the relative and perceived value of nonconformances, and the resulting inactivity when people in charge do not agree with the CARs. What happens after this lack of activity from the QA Manager? If nothing, I wonder if the CARs really were important.

It makes sense for the audit team to review the CAs together and come to an agreement on the CAs' relevance, practicality and value. The added visibility could also help understand if the issue is occurring in another process. If you can get this done it may help - maybe you can make the QA manager agree it would lighten his work load. :

 

[somashekar]

Re: CAPA

Who decides what is urgent and what is non-urgent.
Do the non-urgent become urgent at a later time, or do they remain non-urgent.
If they become urgent, then they get addressed, hence no issue.
Can you along with QM / 3 auditors, or others assess to find out if any of the non-urgent, if addressed will reduce any typical urgent stuff that keeps coming up...
If you do, then someone has suggested a PA situation.
Convert to urgent and address the same.
If you assess that addressing any non-urgent would not reduce the frequency or numbers of any urgent stuff, then assess if it makes any work easier / faster. Does it need an investment or can it be tried with some changes as suggested.
If Yes, then feel free to propose for investment with due justification OR make changes on a trial basis with due permissions.
If No, feel free to discard.

 

[John Broomfield]

Re: CAPA

goldcoastwestie,

Please post your Problem Notification Form here. I doubt it calls for sufficient information for the CEO to determine the value of solving the reported problems.

Are you saying the top manager is failing to demonstrate commitment to customers, quality and improvement? As the auditor have you had a private face to face discussion with the CEO of the evidence and consequences of this?

Normally, problem notifications go through the system manager's office or a panel or small committee before becoming formal requests necessary to invoke preventive or corrective action.

It appears that your CEO needs help to become an effective system manager. A 3 person cross-functional committee may provide the resources required to encourage timely problem solving at the system-wide level. Supervisors may already engage their employees in making local improvements on a daily basis.

Lastly, please note the order. Preventive action should happen before corrective action not as implied by the acronym CAPA.

John