"Control" as used in 4.1 c) - Process Flow Charts (Process Sequence Chart)

[Paul Simpson]

Thank you. TS and ISO audit has become a stressful experience because, the audits seems to make their own rules. They do not like our documentation and it turns out to be a negotiation experience.

Couple of points. The automotive industry developed QS-9000 and the auditor qualification process and subsequently followed this up with TS 16949 and their own control of auditor qualification specifically because they were unhappy with accredited certification of their suppliers to ISO 9001.

So how far have we come? This (and examples from the Cove and my own experience) indicate the system is just as bad / corrupt as the days of the CBs managing the process themselves and even the days of 2nd party audits by the OEM's SQA engineers.

The 'boardroom' auditor is alive and well - when I used to do auditor training I recounted stories like this to delegates and they were always open mouthed in horror. I've now supplanted this story with one of a 2 auditor / 1 day audit that started and finished in the time it took the QM to go from the board room to the coffee machine and back.

It never ceases to amaze me how many bad apples there are out there and how anyone can have so little respect for their profession and themselves to be seen in this light.

BTW - rant over - you are 100% right that the controls don't have to be in the flow diagram. The automotive industry above most is renowned for documenting process controls - think process flow diagrams, FMEA, control plan from the supporting manuals for TS.

 

[qusys]

Couple of points. The automotive industry developed QS-9000 and the auditor qualification process and subsequently followed this up with TS 16949 and their own control of auditor qualification specifically because they were unhappy with accredited certification of their suppliers to ISO 9001.

So how far have we come? This (and examples from the Cove and my own experience) indicate the system is just as bad / corrupt as the days of the CBs managing the process themselves and even the days of 2nd party audits by the OEM's SQA engineers.

The 'boardroom' auditor is alive and well - when I used to do auditor training I recounted stories like this to delegates and they were always open mouthed in horror. I've now supplanted this story with one of a 2 auditor / 1 day audit that started and finished in the time it took the QM to go from the board room to the coffee machine and back.

It never ceases to amaze me how many bad apples there are out there and how anyone can have so little respect for their profession and themselves to be seen in this light.

BTW - rant over - you are 100% right that the controls don't have to be in the flow diagram. The automotive industry above most is renowned for documenting process controls - think process flow diagrams, FMEA, control plan from the supporting manuals for TS.

Agree with you Boris.
However the original poster mentioned ISO 9001 not ISO TS that includes Control plan etc. etc. where to report controls.
I confirm that the CB auditor ( as the same poster said) was not so open mind, as ISO 19011 suggests, in finding the related controls in the associated procedures or work instructions or other document that the oganization declared to use to make its QMS work in effective way.

 

[Paul Simpson]

Agree with you Boris.
However the original poster mentioned ISO 9001 not ISO TS that includes Control plan etc. etc. where to report controls.

My apologies. I'm having a bad 'standard spotting' day. I followed LUV-d-4UM's reference to TS and didn't check back through the full thread. 13485 is mentioned in one of the OP's posts and I am sure there is a similar requirement for control mechanisms under Medical Device legislation. The 'coffee machine' audit example I gave was TS.

I confirm that the CB auditor ( as the same poster said) was not so open mind, as ISO 19011 suggests, in finding the related controls in the associated procedures or work instructions or other document that the oganization declared to use to make its QMS work in effective way.

Agreed. Generally process controls are specified in process measures, procedures and control plans not in the Manual.