IATF 16949 Clause 8.5.6.1.1 - Temporary Change of Process Controls

Peters

Quite Involved in Discussions
#1
I have a problem with 8.5.6.1.1 Temporary change of proces controls
1.I have a problem with interpretation of this text:

The organization shall identify, document, and maintain a list of the process controls…
…The organization shall maintain and periodically review o list of approved alternate process control methods that are referenced in the control plan.


The text indicates that the list of alternative tests and inspections is expected, which is not a control plan. Question how does it differ from the control plan, what structure and content should it has? Would it be more a part of the control plan (as variant lines) or a completely separate document? Does it contain only list of alternative gages/devices or also list of alternative measurements with alternative frequency, sampling and criteria?

2.I have a problem with understanding of this text:

Restart verification is documented for a defined period based on severity and confirmation that all features of error-proofing device or process are effectively reinstated.

What is “Restart verification” in this context?
What is “defined period” in this context?
What is “features” in this context?
 
Last edited:
Elsmar Forum Sponsor

Sebastian

Trusted Information Resource
#2
Re: IATF 16949 Clause 7.5.6.1.1 - Temporary Change of Process Controls

The organization shall identify, document, and maintain a list of the process controls…
…The organization shall maintain and periodically review o list of approved alternate process control methods that are referenced in the control plan.


The text indicates that the list of alternative tests and inspections is expected, which is not a control plan. Question how does it differ from the control plan, what structure and content should it has? Would it be more a part of the control plan (as variant lines) or a completely separate document? Does it contain only list of alternative gages/devices or also list of alternative measurements with alternative frequency, sampling and criteria?
In further part of this sentence process controls are referring to listed devices and related methods. Coming from risk based thinking, we shall select back-up devices and methods during APQP activities, document them and get customer approval in advance, if required.
It may be documented by:
- control plan (e.g. additional line in Evaluation/Measurement Technique column in AIAG form),
- contingency plan (e.g. table listing alternate work (inspection) instruction in case of primary control device failure),
- other document.

Focus of "back-up / alternate" words is on device & methods, but I see there also "opportunity" for specification, control frequency or sample size of controlled characteristic. "Opportunity" means, that "back-up / alternate" can make them only more severe e.g. specification range narrowed due to lower reliability of alternate inspection device.
Restart verification is documented for a defined period based on severity and confirmation that all features of error-proofing device or process are effectively reinstated.

What is “Restart verification” in this context?
What is “defined period” in this context?
What is “features” in this context?
Similar wording we can find in GM CSR Section 4.1.21 Bypass Management, but "bypassing" sounds a little bit "negative" to me, comparing to "back-up".
 

joekirk

Involved In Discussions
#3
I had an interested discussion with an IATF auditor yesterday regarding this clause.

My interpretation is that you would develop and document back-up or alternate methods for inspection processes based on risk and include those in our process control plan.

Auditors interpretation is that you must have a back-up or alternate method for each process control listed on the control plan.

Someone please clarify.
 

Peters

Quite Involved in Discussions
#4
Auditors interpretation is that you must have a back-up or alternate method for each process control listed on the control plan.
I can't see such requirement in 8.5.6.1.1
What for?
For example:
Auditee: For this inspection my inspector uses caliper.
Auditor: Please show me back-up or alternate method for this process control.
Auditee: What for?! I have a lot of inspectors and a lot of calipers!
 

jelly1921

Quite Involved in Discussions
#5
I had an interested discussion with an IATF auditor yesterday regarding this clause.

My interpretation is that you would develop and document back-up or alternate methods for inspection processes based on risk and include those in our process control plan.

Auditors interpretation is that you must have a back-up or alternate method for each process control listed on the control plan.

Someone please clarify.
Not for each process control.

IATF training PPT comments:
• This new requirement for temporary control of process changes addresses issues experienced by the IATF OEM customers.
• The organization must identify, document, and maintain a list of process controls that includes both the primary process control (example: automated nut driver) and the approved back-up or alternate methods (example: manual torque wrench). The list must be updated regularly to reflect the current and approved process controls.
• The use of alternative control methods is considered a process; therefore, the organization is expected to manage these activities appropriately.

GM's CSR says more clearly: The organization shall keep a list of all error proofing devices and identify which can be bypassed and which cannot (also see clause 8.5.6.1.1).

Jelly
 

QualitySpirit

Involved In Discussions
#6
What is “Restart verification” in this context?

Verification after the standard process controls have been resumed.

What is “defined period” in this context?

A period of close monitoring after the standard process controls have been resumed. It should be based on severity if it has a high severity then it should be closely monitored for a longer period.

What is “features” in this context?

Features = intents of each process controls - it must be made sure that all process controls are working as they are intended to.
 

Blaest

Involved In Discussions
#7
I had an interested discussion with an IATF auditor yesterday regarding this clause.

My interpretation is that you would develop and document back-up or alternate methods for inspection processes based on risk and include those in our process control plan.

Auditors interpretation is that you must have a back-up or alternate method for each process control listed on the control plan.
During training at SMMT Industry Forum Birmingham the trainer had the exact same attitude and insisted for an alternate control methold for each inspection on the control plan, he even stated that every entry on the control plan was by definition an inspection - so this would mean every control plan would be exactly double the size compared to TS 16949 requirements. Now that I look for the 'shall' it it not so easy to see why the trainer put it like that.
 
#8
Hi

I have two questions:

1- do you think the third party auditor will look for "a list" of all primary and back up process controls? or as long as those items are listed in the control plan, it would be enough? I mean should we keep a separate list for this clause?

2- do we need alternative methods for all process controls, or we can determine which ones we can bypass?

in our plant, we have more than 10,000 process controls, including automated, error-proofing, manual, visual, etc.
 

mihir.bajekal

Starting to get Involved
#9
Hi

I have a question. We were recently audited for IATF 16949 by a third party auditor. During the audit, he raised a non conformity for not having covered contingency plan in the temporary change of process controls. However, after going through the standard once again, I could not find any linkage to that. So, can anyone confirm to me whether the two are linked and whether we should include the contingency plan also in the same document?

Mihir
 

Sebastian

Trusted Information Resource
#10
6.1.2.3 c) prepare contingency plans for continuity of supply in the event of any of the following: key equipment failures (also see Section 8.5.6.1.1)
He was right, as expected.
 
Thread starter Similar threads Forum Replies Date
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
P IATF 16949 Clause 8.4.2.3 - Justification for non-certified suppliers IATF 16949 - Automotive Quality Systems Standard 14
M IATF 16949:2016 clause 8.4.2.3 - We don't have ISO 9001:2015 certificate IATF 16949 - Automotive Quality Systems Standard 26
R Material safety data sheet (MSDS) related clause in IATF 16949 manual IATF 16949 - Automotive Quality Systems Standard 17
R IATF 16949 Clause 8.5.1.6 a) maintenance and repair facilities - Production tooling management and personnel IATF 16949 - Automotive Quality Systems Standard 4
QChas IATF 16949 Clause 8.5.1.2 - C -Standardized Work IATF 16949 - Automotive Quality Systems Standard 1
N Looking for input on the attached Process / IATF 16949 Clause Matrix IATF 16949 - Automotive Quality Systems Standard 4
R IATF 16949 Clause 6.1.2.1 - Lessons Learned and Risk Analysis IATF 16949 - Automotive Quality Systems Standard 6
L IATF 16949 Clause 9.2.2.2 Quality Management System Audit IATF 16949 - Automotive Quality Systems Standard 9
H IATF 16949 Clause 9.2.2.2 Audit System / CSR IATF 16949 - Automotive Quality Systems Standard 1
B IATF 16949 clause 7.1.5.1.1 - Statistical studies shall be conducted IATF 16949 - Automotive Quality Systems Standard 3
P Interesting Discussion IATF 16949:2016 Clause 9.2.2.3 and Layered Process Audits IATF 16949 - Automotive Quality Systems Standard 18
M Reference to IATF 16949 clause 8.4.3 in clause 8.3.4.4, Is it right? IATF 16949 - Automotive Quality Systems Standard 1
M IATF 16949 Clause 8.3.5.2 sub-clause (l) - Process maintainability requirements IATF 16949 - Automotive Quality Systems Standard 15
J IATF 16949 Clause 9.3.2.1 - How to understand "measures" IATF 16949 - Automotive Quality Systems Standard 4
J How to address IATF 16949 clause 5.1.1.1 in my Quality Manual IATF 16949 - Automotive Quality Systems Standard 6
B IATF 16949 clause 8.3.4.3 Prototype programme IATF 16949 - Automotive Quality Systems Standard 0
DeeDeeM IATF 16949 - Clause 8.5.2 Identification and Traceability IATF 16949 - Automotive Quality Systems Standard 7
W IATF 16949 Clause 6.1.1 - My first Major NCR (Management Review) IATF 16949 - Automotive Quality Systems Standard 57
A Escalation Process - IATF 16949 Clause 4.4.1.2 IATF 16949 - Automotive Quality Systems Standard 11
E IATF 16949 Clause of 8.4.3 - Approvals - Can you explain to me IATF 16949 - Automotive Quality Systems Standard 1
B IATF 16949 Clause 9.2.2.2 - Which QMS Processes are Included IATF 16949 - Automotive Quality Systems Standard 1
J What are sample documents of IATF 16949 Clause 8.6.4 a? IATF 16949 - Automotive Quality Systems Standard 2
S IATF 16949 Clause 8.3.3.3 - Documentation of all Special Characteristics in Drawings IATF 16949 - Automotive Quality Systems Standard 2
B IATF 16949 Section Clause 8.3.4.1 - Monitoring - Design and Development Input(s) IATF 16949 - Automotive Quality Systems Standard 3
B IATF 16949 Clause 8.6.2 - Layout Inspection and Functional Testing IATF 16949 - Automotive Quality Systems Standard 11
B IATF 16949 Clause 9.3.2.1 - Management Review Inputs IATF 16949 - Automotive Quality Systems Standard 1
T Customer Authorization for Concession - IATF 16949 Clause 8.5.1.1 IATF 16949 - Automotive Quality Systems Standard 3
W IATF 16949 Clause 8.4.2.4.1 Second Party Audits (Supplier Management) IATF 16949 - Automotive Quality Systems Standard 45
T Record Retention Requirements - IATF 16949 Clause 7.5.3.2.1 Records and Data - Quality, Legal and Other Evidence 15
B IATF 16949 Clause 8.5.6.1.1 (Temporary Process Control Change) IATF 16949 - Automotive Quality Systems Standard 24
T Temporary Change of Process Controls - IATF 16949 Clause 8.5.5.1.1 IATF 16949 - Automotive Quality Systems Standard 16
B IATF 16949 Clause 8.4.1.2 - Supplier Selection Process - Service Providers IATF 16949 - Automotive Quality Systems Standard 11
J IATF 16949 Clause 8.7.1.7 Nonconforming Product Disposition - Scrap Rendered Unusable IATF 16949 - Automotive Quality Systems Standard 64
M IATF 16949 Clause 4.4.1.2 - Product Safety - Concept of the Title IATF 16949 - Automotive Quality Systems Standard 4
M IATF 16949 Clause 7.1.5.1.1 - What are "inspection equipment systems"? IATF 16949 - Automotive Quality Systems Standard 4
P Setup Verification in IATF 16949 Clause 8.5.1.3 IATF 16949 - Automotive Quality Systems Standard 6
D Does IATF 16949:2016 Clause 7.3 (now 8.3) Apply to "Grandfathered" Products IATF 16949 - Automotive Quality Systems Standard 4
J IATF 16949 Clause 8.7.1.7 Nonconforming Product Disposition Compliance IATF 16949 - Automotive Quality Systems Standard 38
M Exclusion of IATF 16949 Clause 4.4.1.2 - Product Safety IATF 16949 - Automotive Quality Systems Standard 2
P Problem with IATF 16949 Clause 7.2.3 Requirements (Internal Auditor Competency) IATF 16949 - Automotive Quality Systems Standard 3
M IATF 16949 Clause 4.4.1.2 - Product Safety IATF 16949 - Automotive Quality Systems Standard 13
M Compliance with IATF 16949 Clause 8.3.4.4 Product Approval Process IATF 16949 - Automotive Quality Systems Standard 2
dubrizo IATF 16949 Clause 8.7.1.6 - Customer Notification - Your Inputs Requested IATF 16949 - Automotive Quality Systems Standard 4
M IATF 16949 Clause 8.3 - Rework Records Requirements IATF 16949 - Automotive Quality Systems Standard 1
J What results need to be defined in IATF 16949 Clause 8.3.4 IATF 16949 - Automotive Quality Systems Standard 3
P IATF 16949 Clause 10.2.4 - Error Proofing IATF 16949 - Automotive Quality Systems Standard 25
P IATF 16949 Clause 8.5.1.4 - Verification after Shutdown IATF 16949 - Automotive Quality Systems Standard 12
J How to understand IATF 16949 Clause 8.5.6.1.1 - Process Controls IATF 16949 - Automotive Quality Systems Standard 2
J How to understand IATF 16949 Clause 8.5.2.1 - Traceability IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom