IATF 16949 Clause 6.1.2.1 - Lessons Learned and Risk Analysis

  • Thread starter Retired Member 37256
  • Start date
R

Retired Member 37256

#1
The clause 6.1.2.1:
The organization shall include in its risk analysis, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, and rework.

This mean that we should include the lessons learned from product recalls, also lessons learned from product audits, also lessons learned from complaints, and so on?

Or the "lessons learned" is only referred to the "product recall"?

:bonk:
 
Elsmar Forum Sponsor

SamuelB

Starting to get Involved
#3
This mean that we should include the lessons learned from product recalls, also lessons learned from product audits, also lessons learned from complaints, and so on?
That would be the case. In our organization we have FMEAs and some of the risks got added as a result of customer complaint investigations and issues pointed out by internal or external auditors. It's difficult to determine every possible scenario the first time round.
 
R

Retired Member 37256

#4
Uhmm I still don't understand how to satisfy this clause 6.1.2.1, what the auditor expect from our organization?..

Should I prepare a stand alone document where I list historical non conformances data (from product recalls, product audit, complaints, reworks, etc) as a risks and take actions to prevent happen again? If yes, is not this a PFMEA?

Hope anyone can address me with examples? thanks.
 

AMIT BALLAL

Trusted Information Resource
#5
Uhmm I still don't understand how to satisfy this clause 6.1.2.1, what the auditor expect from our organization?..

Should I prepare a stand alone document where I list historical non conformances data (from product recalls, product audit, complaints, reworks, etc) as a risks and take actions to prevent happen again? If yes, is not this a PFMEA?

Hope anyone can address me with examples? thanks.
Assume you had to make product recall / observed NC during production /received customer complaint / any rejection/ rework occurred. You'll do analysis about what was the root cause and what could be / were risks during such cases. Based on this you'll identify actions to be taken and will include same as part of system.

Eg. If you receive a customer complaint, you'll do the problem solving and identify areas where there is a potential risk of occurring same problem and you'll horizontally deploy those actions. This can be used to fulfill requirements of this clause.

Intention and requirement is to learn from failures.
 
Last edited:

jack770214

Involved In Discussions
#6
Risks and opportunities, lessons learned are like improvement. It is rolled into each process not to be a single process or activity by itself. We have a corporate document that describes our R&O procedure and its sources just like continuous improvement. All of our process owners implement that document within the process they own. The only difficulty we may run into is keeping R&O at the level one process level and not forcing people to do this at the activity level 10 levels down.

Sent using Tapatalk
 

Johnson

Involved In Discussions
#7
Firstly the lessons learned should cover all the other items, if applicable.
Secondly you may use a different method for lessons learned, like a Lessons Learned database, a lessons learned list, or a combination of some individual lessons leared documents (like PPT), etc.
 
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
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
P IATF 16949 Clause 8.5.6.1.1 - Temporary Change of Process Controls IATF 16949 - Automotive Quality Systems Standard 21
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