Must we have FMEA for ALL the products by the registration audit?

D

Daniel

#1
#1
Hi.

My company is in the process of implementing QS 9000 and FMEA is currently one of our biggest headaches. By nature of our products, it is almost impossible to implement FMEA for all of them by the certification audit. Can we set up a FMEA implementation master and at least complete a few of the product FMEA? Will this be acceptable to the QS 9000 auditors? Must we have FMEA for ALL the products by the audit?

Please advise.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
D

Don Watt

#2
#2
Would it be possible for you to group products in "families" and then to develop FMEA's to cover a range of products?

If you can do this it should save you a considerable amount of time & effort.
 
A

auditor16949

#3
#3
I would suggest you talk to the registrar to establish their policy and to your customers.
If I were carrying out the audit, I would be looking for evidence that your current APQP system works and is generating FMEAs so I would audit a current project. It might be acceptable to establish a breakpoint, jobs created after a certain date have an FMEA, those before don't.
Will your customer give you a waiver?
How did you gained PPAP approval without FMEAs?
If you don't currently have QS-9000 customers and your existing customers have not required FMEAs then generating historic data may not be necessary.
If you do need FMEAs, I would support the advice given by others to create generic documents if possible, this will undoubtedly be the quickest way.
Good luck.
 
Kevin Mader

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#4
#4
Follow Don's advice. Additionally, you might want to address specific processes individually. You will inevitably reduce the redundancy of effort by doing both.

Regards,

Kevin
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M What kind of instrument that must be calibrated? General Measurement Device and Calibration Topics 3
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Customer VDA Audit - We must provide refresher training? VDA Standards - Germany's Automotive Standards 4
J Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting ISO 13485:2016 - Medical Device Quality Management Systems 13
I Sampling processes - Who must define the AQL level? AQL - Acceptable Quality Level 9
M Which documents must be updated upon product validation? Document Control Systems, Procedures, Forms and Templates 1
Q IATF 16949 - Product audit - Must each product be audited? IATF 16949 - Automotive Quality Systems Standard 6
G From an ISO 17025 auditor perspective must micrometer calibration check anvil flatness? General Measurement Device and Calibration Topics 4
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
T Must all Disposable Medical Devices be DEHP Free for MDR? EU Medical Device Regulations 1
W Product Audit - It must be a separate and distinct activity (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 4
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
S. Moore Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
A ISO 9001:2015 Clause 9.3.2 - Management Review Inputs must be Documented? Management Review Meetings and related Processes 15
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
M Contacting a "Must Use" (aka Sole Source) Supplier's Registrar Supplier Quality Assurance and other Supplier Issues 6
T Auditor states my Oven Thermocouples must be Calibrated General Measurement Device and Calibration Topics 18
K Must I update the Quality Policy? (ISO 9001:2008) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B Must a Design Outsourcing Company have ISO13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
U Must every procedure be proceeded by a policy? Document Control Systems, Procedures, Forms and Templates 2
P Must all parts of a product be RoHS compliant? EU Medical Device Regulations 5
N Must electrodes for Rx/prescription stimulators be Rx only? Other US Medical Device Regulations 2
V Is there an approach to define the "must 'or' should" in supplier audits? US Food and Drug Administration (FDA) 2
F Electronic Signatures (21CFR Part 11) - Must They Appear on Printed Documents Document Control Systems, Procedures, Forms and Templates 9
R What are the "Must Have" Specs and Standards for AS9100 Certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
L Must we do Receiving Inspection for everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
U Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited labs? ISO 17025 related Discussions 8
C Must we identify steps taken to identify the Root Cause of a failure Nonconformance and Corrective Action 15
Y Must every Process have a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
L Must the Signature on a Quality Record be Legible? Records and Data - Quality, Legal and Other Evidence 33
N Must Employees Be Evaluated Annually? Training - Internal, External, Online and Distance Learning 19
AshleyE Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540? ISO 17025 related Discussions 38
D How long must we provide service parts to Ford? IATF 16949 - Automotive Quality Systems Standard 7
E Must Patent Numbers be Shown on Product Labels? Other Medical Device and Orthopedic Related Topics 18
Ronen E FDA Must Have New Authorities to Regulate Pharmacy Compounding US Food and Drug Administration (FDA) 8
P Trip to the USA - Must-Eat Food? Holiday Planning Coffee Break and Water Cooler Discussions 57
Colin What QMS Internal Audits must cover and ISO 9001 Internal Auditing 19
R Is insulation between F type applied part and other parts a must? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Must Forms be referenced in applicable Procedures? Supplier Quality Assurance and other Supplier Issues 6
U Must We Audit Critical Suppliers? How often? Supplier Quality Assurance and other Supplier Issues 7
S Integrating a Multi-Management System - What documents & records must we have? Various Other Specifications, Standards, and related Requirements 6
R Risks which must be Distinctly Identified - Harm, Hazard, Severity ISO 14971 - Medical Device Risk Management 7
O ISO 9001 requirements for what Internal Audits must cover Internal Auditing 7
Q Who must write Quality Manual as per ISO 9001 Clause 5.5.2? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
C Is an Initial Environmental Review a must while implementing ISO 14001 ISO 14001:2015 Specific Discussions 5
R Who must sign 510(k) Submission? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JodiB Interlaboratory Testing - Must they all be accredited? General Measurement Device and Calibration Topics 2
W X-ray based NDT Test Equip. Mfger. seeking CE Mark - Must X-Ray Source be included? CE Marking (Conformité Européene) / CB Scheme 5
Similar threads
Top Bottom