Master FMEA for "like processes" - Does an FMEA have to match the CP and PM directly?

#1
Has anyone created a Master FMEA that covers all possible Item / Functions for "like processes" and then just pulls the relevant Item/Functions into the Control Plan and Process Map for the Individual Processes? Or does a FMEA have to match the CP and PM directly?

Thanks in advance.
 
Elsmar Forum Sponsor

Ron Rompen

Trusted Information Resource
#2
Re: Master FMEA for "like processes" - Does an FMEA have to match the CP and PM direc

Yes, I have created a 'master' PFMEA and Flow Chart in the past, which I used for any new product by cutting and pasting to match the defined process. The control plan would then be made to match the process as defined in the two preceding documents.

It does take some time (and work) to create a good master document, but in the end it is well worth it.
 
#3
Re: Master FMEA for "like processes" - Does an FMEA have to match the CP and PM direc

Thank you Ron, I will bring your response to my team and hope they also agree. I too believe it will drive Standard Work within the plant as a result of a master FMEA.
Jean
 

Golfman25

Trusted Information Resource
#4
Re: Master FMEA for "like processes" - Does an FMEA have to match the CP and PM direc

We do a master FEMA which allows us to create a one time FEMA for anything. What we were finding is that any changes, upgrades, improvements, etc could be applied accross the board and it was impossible to keep everything updated. Now the master is always current and updated as needed.
 
#5
Re: Master FMEA for "like processes" - Does an FMEA have to match the CP and PM direc

Thank you Golfman25, a 2nd vote of affirmation is great to hear. Our team is on board and everyone is looking forward to exactly the results you mentioned - everything updated and easier maintenance going forward. We are putting in the work now on Master FMEAs.
Jean
 

Nadaabo

Starting to get Involved
#6
Re: Master FMEA for "like processes" - Does an FMEA have to match the CP and PM direc

Thanks for asking this. I would love to know how the implementation went :) I have been to get my team to consider this, but everyone is too scared it's a huge undertaking.
 
#7
Re: Master FMEA for "like processes" - Does an FMEA have to match the CP and PM direc

Your team is correct, it is a huge undertaking, but today I can speak to the benefits of the work involved. We committed a cross-functional team to 3 meetings a week to stress the importance that once we started this we could not stop until complete.
we have been working for months, but the end is near.

First we listed all individual FMEAs and then grouped them into the Master Families of products. We went from 33 Ind. FMEAs to 16 Master Families FMEAs. ( some groups must stand alone.

The first FMEA was of course was the most difficult to get through. But once we did, we all had a good feeling for what we were about to accomplish. We brought in SMEs from each processes so the scoring was fair and accurate.( Sev., Occ., & Det.)

Our benefits to date: Std. Work improved plant wide; CARS will cover "Like products" easier; Process Audits will be simplified; Future Product Planning will be simplified; Document Updates, time saving and greatly improved; and Internal Audits, redundancy reduced.

Go for it.
 

Golfman25

Trusted Information Resource
#8
Re: Master FMEA for "like processes" - Does an FMEA have to match the CP and PM direc

Your team is correct, it is a huge undertaking, but today I can speak to the benefits of the work involved. We committed a cross-functional team to 3 meetings a week to stress the importance that once we started this we could not stop until complete.
we have been working for months, but the end is near.

First we listed all individual FMEAs and then grouped them into the Master Families of products. We went from 33 Ind. FMEAs to 16 Master Families FMEAs. ( some groups must stand alone.

The first FMEA was of course was the most difficult to get through. But once we did, we all had a good feeling for what we were about to accomplish. We brought in SMEs from each processes so the scoring was fair and accurate.( Sev., Occ., & Det.)

Our benefits to date: Std. Work improved plant wide; CARS will cover "Like products" easier; Process Audits will be simplified; Future Product Planning will be simplified; Document Updates, time saving and greatly improved; and Internal Audits, redundancy reduced.

Go for it.
That's a pretty good list. And a lot will depend on your processes. Ours are pretty simple -- a punched hole is generally a punched hole regardless of the application.

The only thing I would caution is be careful of what industry you're in. Anything other than automotive (aerospace might have different requirements), IMO modify the concepts to fit you. But in Automotive, people generally freak out if you do something that makes sense when it isn't by the book. So you need to be ready to "explain."
 
Thread starter Similar threads Forum Replies Date
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
Q Forms Master List versus Record Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
R No design history file or device master record ISO 13485:2016 - Medical Device Quality Management Systems 5
Sam Lazzara Medical Device File (MDF per 13485:2016 4.2.3) versus FDA Device Master Record (DMR) ISO 13485:2016 - Medical Device Quality Management Systems 3
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
M Master Dot for quality planning/improvement Manufacturing and Related Processes 1
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 7
G Comparing Gauge Blocks - Translating the calibration between the master set and the QA set General Measurement Device and Calibration Topics 2
R Are DMR (device master record) and DHR (device history record) inspected by FDA or audited by an NB ISO 13485:2016 - Medical Device Quality Management Systems 6
S Foreign Manufacturer and DMR - Who keeps the DMR (Device Master Record)? ISO 13485:2016 - Medical Device Quality Management Systems 2
S DMR (Device Master Record) for Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 3
D Design Outputs vs DMR (Design Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Carbon Black (Master Batch) - Basic Requirements Manufacturing and Related Processes 5
H Korea DMF (Drug Master File) Fees Various Other Specifications, Standards, and related Requirements 5
K Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template Qualification and Validation (including 21 CFR Part 11) 4
R Master Gage Block Calibration (We have 2 sets) question General Measurement Device and Calibration Topics 3
P DMF (Drug Master File) type V for Sterilization Processes for USFDA Submission Other US Medical Device Regulations 3
S Looking for templates of Master Production Record and Master Batch record Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
T Master Document List - Obsolete Documents Document Control Systems, Procedures, Forms and Templates 23
V Site Master File for multiple business units within same premises/facility Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
rob73 Digital DMF (Device Master File) Records EU Medical Device Regulations 3
I DMR (Device Master Records) and similar for standalone software device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Switching Master Product in EO (Ethylene Oxide) Other Medical Device Related Standards 5
S Device Master Records for a Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S DMR (Device Master Record) Management and Index questions Other US Medical Device Regulations 18
P "Bayer" Black Resin vs. Master Batch Manufacturing and Related Processes 1
R Master Level - I would appreciate any input on a Master Level Calibration and Metrology Software and Hardware 1
J Referencing the DMR (Design Master Record) in the PO Document Control Systems, Procedures, Forms and Templates 2
C Lowest Acceptable Grade for Master Gage Set Calibration and Metrology Software and Hardware 1
C Calibration of Master Thread Plug Gages General Measurement Device and Calibration Topics 2
P DMR (Device Master Record) for Class I and Class II Dental Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
G Where to get a NIST Traceable Master Glass Refractive Index Sample General Measurement Device and Calibration Topics 5
M ASQ CMBB Master Black Belt - anyone appearing for Mar 1, 2014 exam ? Professional Certifications and Degrees 6
H Is "Master Documents and Records list" required per ISO 9001 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Error in Master Weighing Stone General Measurement Device and Calibration Topics 2
J Resistance to Change as a Master Thesis in Quality Assurance Professional Certifications and Degrees 7
I Device Master Record Requirements for Component Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B Degree equivalent to a US Master Degree Career and Occupation Discussions 1
S Help with Master Thesis focusing on ISO/TS 16949 and CSR in automotive SC IATF 16949 - Automotive Quality Systems Standard 2
P The difference between Six Sigma Black Belt and Master Black Belt Six Sigma 2
R Change of DMF (Drug Master File) US Food and Drug Administration (FDA) 2
T Document Control Master List for Obsolete Documents Document Control Systems, Procedures, Forms and Templates 6
S MDR (Master Document Register) for Planning of Documents in Process Engineering Document Control Systems, Procedures, Forms and Templates 2
K Calibration Standards - Master weight having more tolerance than our gram scale General Measurement Device and Calibration Topics 3
drgnrider Bore Gage and Adjustable Set Master General Measurement Device and Calibration Topics 3
S Site Master File inquiry - Distribution in India EU Medical Device Regulations 6
N Uncertainty of Calibration Master Reference Measurement Uncertainty (MU) 1
R Retention Period requirements for DMFs (Drug Master Files) US Food and Drug Administration (FDA) 4
K Definition MVP (Master Validation Plan) and VMP (Validation Master Plan) - Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4

Similar threads

Top Bottom