CAPA

Scenario - Quality Head making the Pareto diagram Defect wise and Part wise after month completion. And sent it to the Production Heads of different sections via mail to take the action and submit the CAPA.
My question is that- Is it right way of working to send Pareto to Production HOD and expect from Production to make CAPA by leading himself without involving the quality person?
In my opinion it should be lead by Quality and involves the other department for analysis and implementing the agreed action.
what do you say?

*CA & root causes determinations or analysis are the responsibility of audited / process owner " production Mgr. in the case above " , the auditor & Q. stuff should be independent in this stage ;
*verification ; follow up & closeout of NCs should be done by auditor / Q. Mgr. " as the process statements" ; it’s done after agreed completion time of the action taken / action plan completion ;
*Pareto chart is a tool for analysis; it’s could be done after gathering enough information , in above case it's not a tool for measuring the correction & corrective action effectiveness in this stage , in this stage the correction & corrective action should be initiated without delay; it’s initiated as raising the finding & audit reports ; the auditor should be away of any determinations of NCs causes including any analysis ;
*the above cycle considerations should be done hardcopy or electronically;
*Pareto should be done after closing out all opened points & after checking the effectiveness ' it's a tool for measuring the effectiveness also ; let's the analysis tool is the responsibility of each process owner ; the company management system should clearly define this responsibility ; anyhow the final review of all system elements should be inputs of management review including risk determination

For clarification: are you talking about product defect/nonconformance or audit findings/nonconformance?
If this is product defects then having QA perform the Pareto analysis and asking the production or product engineering group to initiate and lead the problem solving is appropriate. In my experience it is best to have a cross-functional small team that includes Quality, Production and Engineering. It is also best to have someone on the team who can coach them in problem solving methods.

abdul42550 said:

Scenario - Quality Head making the Pareto diagram Defect wise and Part wise after month completion. And sent it to the Production Heads of different sections via mail to take the action and submit the CAPA.
My question is that- Is it right way of working to send Pareto to Production HOD and expect from Production to make CAPA by leading himself without involving the quality person?
In my opinion it should be lead by Quality and involves the other department for analysis and implementing the agreed action.
what do you say?

Click to expand...

In your opinion?
How about their opinion which seems to be the way they are doing it.
Now my opinion is "Do it the way it works for you unless required to do otherwise"

Bev D said:

For clarification: are you talking about product defect/nonconformance or audit findings/nonconformance?
If this is product defects then having QA perform the Pareto analysis and asking the production or product engineering group to initiate and lead the problem solving is appropriate. In my experience it is best to have a cross-functional small team that includes Quality, Production and Engineering. It is also best to have someone on the team who can coach them in problem solving methods.

Click to expand...

Yes talking about the Quality Defect

Than

Enghabashy said:

*CA & root causes determinations or analysis are the responsibility of audited / process owner " production Mgr. in the case above " , the auditor & Q. stuff should be independent in this stage ;
*verification ; follow up & closeout of NCs should be done by auditor / Q. Mgr. " as the process statements" ; it’s done after agreed completion time of the action taken / action plan completion ;
*Pareto chart is a tool for analysis; it’s could be done after gathering enough information , in above case it's not a tool for measuring the correction & corrective action effectiveness in this stage , in this stage the correction & corrective action should be initiated without delay; it’s initiated as raising the finding & audit reports ; the auditor should be away of any determinations of NCs causes including any analysis ;
*the above cycle considerations should be done hardcopy or electronically;
*Pareto should be done after closing out all opened points & after checking the effectiveness ' it's a tool for measuring the effectiveness also ; let's the analysis tool is the responsibility of each process owner ; the company management system should clearly define this responsibility ; anyhow the final review of all system elements should be inputs of management review including risk determination

Click to expand...

thanks for sharing input

Don't be closed to other ideas or methods. If what they are doing is working, then go with it. If it's not working, try to help them improve it so it does, or help them find a better method. It's always best to work as a team, but not everyone works well that way. Have you attempted to understand their reasoning for doing it that way? Ask them why it's done this way.

abdul42550 said:

My question is that- Is it right way of working to send Pareto to Production HOD and expect from Production to make CAPA by leading himself without involving the quality person?
In my opinion it should be lead by Quality and involves the other department for analysis and implementing the agreed action.
what do you say?

Click to expand...

What does your QMS process documentation say? Who is listed as responsible for creating CAPAs (or CAPAs specifically for quality defects)?

If your QMS documentation does not say, then I agree with you that it could be more helpful for Quality to work collaboratively with Production, but it depends on company culture, etc. At the very least, Quality should be available as a resource in such matters.

*if there’s culture of Quality orientation in organization ;” i.e.: self detection; self control ; self direction; if they do the best to determine the causes of deviations ; discovering problem which equal to discover opportunity for improvement ; they always sharing the lessons generated from problems happened ; top management are sharing them in decision making accordingly ,---- encourage the all to be more competent & cumulated experienced by the time ; --- etc,--- this organization work environment could be added value for more progressing & more sustainable ----*if this is the work environment ‘ I see we shouldn’t be stand alone ; we are always have open invitation to share information & completely be involved with the 10 fingers in manufacturing team work & problem solving & sustainable improvement;

* actually this not work environment & not organization culture ; all above are slogans & still materials in Q. awareness courses ; therefore the separation of rules & independent responsibility should be settled in processes ,not all have this culture or ability to build; many are still mixing money with characters trends ;limited managerial/ leadership skills ; ---the decisions issues & the actually spread seeds are far of what they announce

* hence the 20 fingers should be apart from involving ; Quality stuff main duties could be still routine ‘ as upgrading the system according certification requirements , systematic independent checking of the compliance ; evaluate the effectiveness of actions taken ; upgrading the system measures accordingly

Tagin said:

What does your QMS process documentation say? Who is listed as responsible for creating CAPAs (or CAPAs specifically for quality defects)?

If your QMS documentation does not say, then I agree with you that it could be more helpful for Quality to work collaboratively with Production, but it depends on company culture, etc. At the very least, Quality should be available as a resource in such matters.

Click to expand...

Thanks for valuable input