"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?
 
Last edited:
Elsmar Forum Sponsor

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

Super Moderator
#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

Super Moderator
#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.
 
Thread starter Similar threads Forum Replies Date
S Different Standard Deviations used in Control Charting Statistical Analysis Tools, Techniques and SPC 8
S used excel formula calculated the ARL's with Rule1&Rule2 for Shewhart control chart Statistical Analysis Tools, Techniques and SPC 0
Q Control of Standard Operating Manuals used as Reference AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q How to Control Forms used across Multiple Sites Document Control Systems, Procedures, Forms and Templates 8
M Has anyone used "Paradigm 3" software to Control their Quality or Management System? Quality Tools, Improvement and Analysis 2
E Could a BBS (internal forum like phpBB) be used as a Document Control System? Document Control Systems, Procedures, Forms and Templates 3
J What Control Chart should be used for Microbial Limit (NMT 100 cfu/m3) Statistical Analysis Tools, Techniques and SPC 12
O Methods used to Control Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N How do you control weblinks used for external document requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Labels - How do you control the number of product labels printed, scrapped and used? Document Control Systems, Procedures, Forms and Templates 5
M 21 CFR Part 11 & Control of Raw Data Records used as input into Validated Spreadsheet Qualification and Validation (including 21 CFR Part 11) 2
D Control of Fixtures used during Machining ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Operator understanding of what Control Plans are and how they are used Document Control Systems, Procedures, Forms and Templates 8
T What is Average Run Length & Average Production Length when used in Control Charts? Statistical Analysis Tools, Techniques and SPC 4
A Dynamic Control Plan used by Ford Powertrain division APQP and PPAP 5
S Are 'Standard Work Documents' used by "All" who implemented LEAN & Control Needed? Lean in Manufacturing and Service Industries 33
I Can Change Control be used to Control Major Infrastructural Projects? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Has anyone heard of or used ITAZ doQuments for document control? Document Control Systems, Procedures, Forms and Templates 1
C Acceptance sampling should never be used for processes in statistical control Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Electronic Forms control - Making sure the most current version of a form was used Document Control Systems, Procedures, Forms and Templates 13
B Can Training be used as Preventative Control on FMEA? FMEA and Control Plans 10
J ISO 9001:2000 - 4.2.3 Control of Documents - Used to be document and data control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Document Control Matrix - Will it ever be used? Document Control Systems, Procedures, Forms and Templates 11
H 4.16 File Index per department? List used as the Record Control List (4.16)? Records and Data - Quality, Legal and Other Evidence 2
T Linking Control Plans and PFMEA's FMEA and Control Plans 2
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 7
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
D All Dimensions listed on control plan FMEA and Control Plans 10
W Need for current design or process control FMEA and Control Plans 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Control chart and sample time Statistical Analysis Tools, Techniques and SPC 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
J Control chart for huge sample size Statistical Analysis Tools, Techniques and SPC 9
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
J 510(k) for a control kit for an external IVD test kit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom