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

RCW

Quite Involved in Discussions
#1
I have a flow diagram (Process Sequence Chart) in my quality manual which shows the flow of information and material between functions (purchasing , incoming inspection, assembly, shipping, etc.). During a recent audit, there was a finding that "the chart does not clearly document the methods of control of these processes as referenced in clause 4.1" Besides showing the flow of manufacturing from customer (start) to shipping (finish), I also have another page which shows activites such as internal audits, training, corrective action, customer feedback and how it relates to each of these same functions (as stated above). What am I missing as far as 'controls'?
Besides that, where is it required that controls be documented, other than the required documented procedures referenced in the standard?
 
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Randy

Super Moderator
#2
Re: "Control" as used in 4.2 c)

All control means is "show how you manage the way it happens" and you don't have to do it in some chart which isn't required to begin with. Your demonstration of control is contained within the verbiage of your manual, procedures and instruction.
 

RCW

Quite Involved in Discussions
#3
Okay, here is what I responded with in the Cause of the Nonconformity in my corrective action response:

- Clause 4.1 c) states to “determine criteria and methods…” but does not explicitly state to “document” the methods, especially in a chart form. Methods used to control the processes identified in the chart are defined in the quality procedures, an index of which is listed in Appendix X of the Quality Manual, document number.

The auditor's response:

Root cause insufficient with regard to specific methods used to control these processes.


This is really ticking me off! :mad:
Any suggestions on how to proceed with this??
 

Big Jim

Trusted Information Resource
#4
Okay, here is what I responded with in the Cause of the Nonconformity in my corrective action response:

- Clause 4.1 c) states to “determine criteria and methods…” but does not explicitly state to “document” the methods, especially in a chart form. Methods used to control the processes identified in the chart are defined in the quality procedures, an index of which is listed in Appendix X of the Quality Manual, document number.

The auditor's response:

Root cause insufficient with regard to specific methods used to control these processes.


This is really ticking me off! :mad:
Any suggestions on how to proceed with this??
Have a talk with your CB.

The auditor seems to be making up his own rules. 4.1 does not require you to include such information in your interaction of processes description. For that matter, it does not require you to use a chart. Technically, the only requirement as far as documentation of you interaction of processes is concerned is in 4.2.2 which says that you need to describe the interaction of processes in the quality manual. 4.2.2 doesn't even require that the sequence be included in the quality manual. Obviously he is inflexible so it is time to go over his head. You did the right thing by trying to talk to him first, but his response is inappropriate.

Before doing anything else, it may help if you post exactly what he wrote on the original nonconformance so we can help you understand what the requirement actually is.
 

RCW

Quite Involved in Discussions
#5
Before doing anything else, it may help if you post exactly what he wrote on the original nonconformance so we can help you understand what the requirement actually is.
4.1 The following observations are made with regard to quality management system processes:
• The Process Sequence Chart Appendix X of the Quality Manual document number does not clearly identify service as a QMS process
• The chart does not clearly document the methods of control of these processes as referenced in clause 4.1 of ISO 13485: 2003.


The first bulleted finding I can accept. Since our servicing and test/manufacturing departments are one in the same, it was an oversight in not calling out servicing. The second bulleted finding is the one this post is referring to.
 

qusys

Trusted Information Resource
#6
4.1 The following observations are made with regard to quality management system processes:
• The Process Sequence Chart Appendix X of the Quality Manual document number does not clearly identify service as a QMS process
• The chart does not clearly document the methods of control of these processes as referenced in clause 4.1 of ISO 13485: 2003.


The first bulleted finding I can accept. Since our servicing and test/manufacturing departments are one in the same, it was an oversight in not calling out servicing. The second bulleted finding is the one this post is referring to.
Can you also atatched the chart flow so that we can see?
My guess is that the auditor found that the planned results for this process were not achieved, so that he wrote that the control criteria were not present.
I do not believe that the organization has not established them, I think you have procedures and other evidences and you can show them to him.
Explain the dynamic of the audit, if yiu really showed them to hin and showed their effectiveness. It could only be a documental issue.
Pls let us know:bigwave:
 

RCW

Quite Involved in Discussions
#7
Can you also atatched the chart flow so that we can see?
I would prefer not to disclose it here.

My guess is that the auditor found that the planned results for this process were not achieved, so that he wrote that the control criteria were not present.
That could be but I doubt it. He sat at the table for two days looking at procedures and spent less than an hour actually walking the production floor and looking at output records.

I do not believe that the organization has not established them, I think you have procedures and other evidences and you can show them to him.
Explain the dynamic of the audit, if yiu really showed them to hin and showed their effectiveness. It could only be a documental issue.
Pls let us know:bigwave:
He doesn't accept how my system works as there are only two quality systems out there, his way and the wrong way. No, he didn't say that but his attitude sure projected that opinion.
 

Big Jim

Trusted Information Resource
#8
I would prefer not to disclose it here.



That could be but I doubt it. He sat at the table for two days looking at procedures and spent less than an hour actually walking the production floor and looking at output records.



He doesn't accept how my system works as there are only two quality systems out there, his way and the wrong way. No, he didn't say that but his attitude sure projected that opinion.
When you talk to your CB, let them know the the auditor spent nearly all his time in the conference room. They won't like that.
 
J

JaneB

#9
He sat at the table for two days looking at procedures and spent less than an hour actually walking the production floor and looking at output records.

He doesn't accept how my system works as there are only two quality systems out there, his way and the wrong way. No, he didn't say that but his attitude sure projected that opinion.
That's unacceptable from many points of view.

No auditor can make up their own rules - from what you say in other posts, it sure sounds like he is.

I'd take it up with the CB - get on to his boss or your client contact and request a change of auditor and explain why. Be polite, factual and objective. Don't worry that it will 'count against' you. It won't.

You neither want or need an auditor who spends 2 days at a table reading procedures and less than an hour actually looking!! That's quite appalling. I had an auditor in a client site once who did something not unlike that - I took it straight back to the CB and said 'not again'.

I also refused to accept the audit report, because it couldn't be valid. I told them I would only do that IF they (in their office) verified it by reviewing which particular samples and evidence the auditor had actually examined - because he spent about 30 mins in the client's workshop (a 1-day audit). They withdrew it.

Really - this kind of auditor needs recalibrating, retraining or redirecting. Don't put up with it.
 

LUV-d-4UM

Quite Involved in Discussions
#10
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.
 
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