IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

Peters

Quite Involved in Discussions
#1
I have a problem with the interpretation of the "risk assessment" in gages control.

7.1.5.2.1 Calibration/verification records
b) any out-of-specification readings as received for calibration/verification;
c) an assessment of the risk of the intended use of the product caused by the out-of-specification condition

Risk assessment - before or after?
First option: Preparation for each measurement (and each gage) the assessment of the risk associated with the failure of every gage used in measurements and giving incorrect results.
Second option: After finding the failure of the gage - preparation of the risk assessment for this gage failure (risk connected with giving by this gage incorrect results).
First option - it will be a lot of work...
 
Elsmar Forum Sponsor

qusys

Trusted Information Resource
#2
Re: Problem with 7.1.5.2.1 "Calibration/verification records" interpretation

In my opinion this clause comes from the prior 7.6.2. of the old standard. The focus should be on the measured product that could be potentially suspect, just in case.

In my opinion the risk assessment could be done after the organization has caught a non conformity and evaluate the risk to ship a potential non conforming product to customer. The organization could analyze other additional data and evaluate that risk.

At a prior stage the organization could make a risk assessment from a general standpoint of the measurement system in place, to decide the risk to manage or accept for that process.
 

Sebastian

Trusted Information Resource
#3
Re: Problem with 7.1.5.2.1 "Calibration/verification records" interpretation

Risk assessment - before or after?
First option: Preparation for each measurement (and each gage) the assessment of the risk associated with the failure of every gage used in measurements and giving incorrect results.
Second option: After finding the failure of the gage - preparation of the risk assessment for this gage failure (risk connected with giving by this gage incorrect results).
First option - it will be a lot of work...
7.1.5.2.1 requires risk assessment after out of specification condition was found and 6.1~ sections require risk assessment before out of specification condition was found.
You have to establish system with documented information clearly pointing when equipment for whom out of specification condition was found, had been used. Limit quantity of inspection equipment used at the same time or record every time ID of inspection equipment used.
 

Peters

Quite Involved in Discussions
#4
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

Thank You!

Next question:

What's the difference between g and i?
g) verification that the software version used for product and process control is as specified;
i) production-related software verification used for product and process control.

Difference I can see:
g) verification of the software version
i) verification of the software (for example - is properly processing the data or not)

That's all?
 
C

cj80f

#5
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

I agree with interpretation, I gave the same.
 
E

ec1608

#6
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

But the scope of verifying the software csn be very wide. Is it really expecting a calibration technician to verify the production-related software? I would expect the tool user to br responsible.
 
A

ashepherd

#7
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

Wondering if anyone has any thoughts related to verifying software version as Peter mentioned below. Obviously any device with software used to inspect to test product product should be managed.

In our scenario, we have vision cameras that are used to verify product components which we believe would be covered by 7.1.5.2.1.

Would this potentially extend to process controllers that are not used to inspect or verify product, but that have an influence on the product such as water temperature controllers or equipment automation PLC's (again that have no designed functionality related to inspection). They are not necessarily inspection and test equipment so I believe the answer is no, but wondering what others interpretation may be.

Thanks,
Aaron


What's the difference between g and i?
g) verification that the software version used for product and process control is as specified;
i) production-related software verification used for product and process control.

Difference I can see:
g) verification of the software version
i) verification of the software (for example - is properly processing the data or not)

 
A

aprice006

#8
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

I have the same question. Have you received any feedback or guidance on the expectations and difference between 7.1.5.2.1 g) & i) ?
 
Y

yw8906

#9
re: IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation

I also confused on different between clause 7.1.5.2.1 g&i. Can anyone clarified on this?:confused:
 

Sebastian

Trusted Information Resource
#10
g)
Work instruction used for product manufacturing, specifies its engineering change level. When needed, it is updated following new engineering change level. This update is identified with a document revision number.
Software used for product and process control shall be treated in a same manner as work instruction. It means controlled and I see here relations to 7.5.3.1 (b) and 7.5.3.2 (a, b and especially c).
At the end we have "...as specified". So, what documented information specifies software version? Work instruction, drawing, testing standard and does currently used version complies to specified one?

i)
Let's take example of welding process. Software specifies displacements, angles and speeds of torch movement and current and voltage parameters during product welding. So, what are real displacement, angle, speed, current, voltage when we press "RUN"?
 
Thread starter Similar threads Forum Replies Date
M IATF 16949 SI # 10: Integrated self-calibration of measurement equipment- Needs for explanation IATF 16949 - Automotive Quality Systems Standard 2
J IATF 16949 Calibration/Verification records question ISO 26262 - Road vehicles – Functional safety 6
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
N IATF 16949 7.1.5.3.2 External Laboratory - Calibration of Nikon machine in factory IATF 16949 - Automotive Quality Systems Standard 24
I IATF 16949, accredited logos, calibration capabilities, etc. IATF 16949 - Automotive Quality Systems Standard 17
B IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
sswaim IATF 16949 7.1.5.3.2 External Calibration Laboratory Requirelents IATF 16949 - Automotive Quality Systems Standard 15
J Calibration/Verification Records (IATF 16949 7.1.5.2.1) IATF 16949 - Automotive Quality Systems Standard 5
J IATF 16949 Calibration Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 22
E IATF 16949 Cl. 7.1.5.2.1 - Calibration and Verification Records Requirements IATF 16949 - Automotive Quality Systems Standard 1
M Producing IATF 16949 compliant calibration certificates IATF 16949 - Automotive Quality Systems Standard 24
B IATF 16949 - 7.1.5.3.1 Internal calibration laboratory requirements IATF 16949 - Automotive Quality Systems Standard 9
J IATF 16949 Cl. 7.1.5.2.1 - Gauges (Measuring Jigs) Calibration/Verification Records IATF 16949 - Automotive Quality Systems Standard 6
M Clarification on Calibration/Verification Records 7.1.5.2.1d (IATF 16949) General Measurement Device and Calibration Topics 11
B Calibration/Verification Records - IATF 16949 section 7.1.5.2.1 f) IATF 16949 - Automotive Quality Systems Standard 6
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
T Justification of "Design Excluded" in IATF 16949 Design and Development of Products and Processes 5
Sidney Vianna Job Opening in the USA - IATF 16949 Lead Auditor Position Job Openings, Consulting and Employment Opportunities 0
Ron Rompen IATF 16949 8.5.1.4 IATF 16949 - Automotive Quality Systems Standard 7
P IATF 16949:2016 Letter of conformity IATF 16949 - Automotive Quality Systems Standard 5
D IATF 16949 SI 10, External non-accredited lab IATF 16949 - Automotive Quality Systems Standard 4
S IATF 16949 - Summary at a glance Clause wise - changes from ISO TS IATF 16949 - Automotive Quality Systems Standard 4
T IATF 16949 Recording inspection results IATF 16949 - Automotive Quality Systems Standard 2
S IATF 16949 Supplier selection criteria 8.4.1.2 IATF 16949 - Automotive Quality Systems Standard 2
D IATF 16949 M&TE Laboratory scope IATF 16949 - Automotive Quality Systems Standard 7
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
D Bulk Materials (Greases) and IATF 16949 IATF 16949 - Automotive Quality Systems Standard 11
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 18
B Remote IATF 16949 audit preparation General Auditing Discussions 10
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 4
B IATF 16949 Cert Expire- New certification body IATF 16949 - Automotive Quality Systems Standard 5
M IATF 16949 - Audit of Remote Location/Support Site and IT IATF 16949 - Automotive Quality Systems Standard 4
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
O Release of Sanctioned Interpretations (SIs) related to Rules 5th Edition and Sanctioned Interpretations related to IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 0
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
R IATF 16949 - Outsourcing of internal audits Internal Auditing 11
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
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 12
L IATF 16949 certification costs IATF 16949 - Automotive Quality Systems Standard 3
B FCA US Customer Specific IATF 16949- Critical Characteristics 8.6.2 Customer and Company Specific Requirements 2
B IATF 16949 News Six month extension on all valid IATF 16949 certs IATF 16949 - Automotive Quality Systems Standard 10
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1

Similar threads

Top Bottom