IATF16949:2016 8.7.1.4 Control of non-applicable reworked product

try2makeit

Quite Involved in Discussions
#1
Hi everyone,

quick question. We don't rework non-conforming parts. The cost of labor would be more extensive than running a new lot of correct parts and tossing the non-compliant. Will I still be required to have a rework FMEA? Or will a simple paragraph stating that rework is not an option because of the cost in labor and time would be more extensive and that we replace non-conforming parts? Would a auditor accept that?

Thanks :)
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Will I still be required to have a rework FMEA?
Common sense says it would be a waste of time and effort to develop a FMEA for something that would never happen.

In your position, I would document the context that rework is non-applicable in your organization, for the reason you have already explained and add a sentence to the effect that, if future products change that context, a rework FMEA would be developed.

Quality systems have to get rid of non-value added documents, processes, systems, etc.

As for your external auditor's potential rejection of your approach, I would "cross that bridge" if and when it comes. The last paragraph in 4.3 supports your position.
 
Last edited:

try2makeit

Quite Involved in Discussions
#3
Common sense says it would be a waste of time and effort to develop a FMEA for something that would never happen.

In your position, I would document the context that rework is non-applicable in your organization, for the reason you have already explained and add a sentence to the effect that, if future products change that context, a rework FMEA would be developed.

Quality systems have to get rid of non-value added documents, processes, systems, etc.

As for your external auditor's potential rejection of your approach, I would "cross that bridge" if and when it comes.
Thank you Sidney. I was thinking the same thing, but needed someone else to confirm my thoughts.
 

Golfman25

Trusted Information Resource
#4
Per 8.7.1.4 you need to do risk analysis "prior to a decision to rework the product." Since your decision will always be no (at this point), you should be fine. Good luck.
 
Thread starter Similar threads Forum Replies Date
S IATF16949:2016 certified without ISO:9001:2015 IATF 16949 - Automotive Quality Systems Standard 9
Jimmy123 IATF16949 Control Plan FMEA and Control Plans 1
M IATF16949 Clause 9.1.2.1e - Customer notification related IATF 16949 - Automotive Quality Systems Standard 4
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
D IATF16949 - Interpretation of Customer Requirements clauses IATF 16949 - Automotive Quality Systems Standard 3
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
P Definition of production tooling in IATF16949 clause 8.5.1.6 IATF 16949 - Automotive Quality Systems Standard 4
I IATF16949 Audit Preparation, Need "searchable" ANPQP 3.1 or latest IATF 16949 - Automotive Quality Systems Standard 1
T QMS Training for my organization - IATF16949 and also AS9100 or 9145 Manufacturing and Related Processes 2
J Your opinion on the better training org for IATF16949 Internal auditor and Lead Auditor IATF 16949 - Automotive Quality Systems Standard 3
K IATF16949 inputs/outputs & KPIs Internal Auditing 3
K Caliso IATF16949 Auditor Training question Internal Auditing 1
D Identifying externally provided services referenced by IATF16949 IATF 16949 - Automotive Quality Systems Standard 2
K IATF16949 8.5.1.5 Total Productive Maintenance IATF 16949 - Automotive Quality Systems Standard 9
E Ask for supplier control procedure which conforms to IATF16949 IATF 16949 - Automotive Quality Systems Standard 0
K Online IATF16949 training Internal Auditing 10
DeeDeeM IATF16949, clause 8.5.2.1 Identification and traceability-supplemental IATF 16949 - Automotive Quality Systems Standard 1
A Documented Processes as per IATF16949 - Requirements for Turtle Diagrams IATF 16949 - Automotive Quality Systems Standard 3
D IATF16949 Second Location Certification IATF 16949 - Automotive Quality Systems Standard 2
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO13485:2016, MDSAP and Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
Louddogsbark When your 13485:2016 certificate has been pulled ISO 13485:2016 - Medical Device Quality Management Systems 2
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
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
K Comparison wanted: ISO 15378:2018 vs. PS9000:2016 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
Q AS9100:2016 D - Intent of 8.4.3 (K) - Implement QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
I IATF 2016 - 8.5.1.4 Verification after shutdown due to COVID19 Process Maps, Process Mapping and Turtle Diagrams 1

Similar threads

Top Bottom