When to Update PFMEA (Process FMEA) - Rejection is found at the customer

jkittle

Involved - Posts
#1
If a rejection is found at the customer and you make a process change, shouldn't the PFMEA be changed?

Under what circumstance would the PFMEA not be changed?
 
Elsmar Forum Sponsor
P

prototyper

#2
Re: When to Update PFMEA

If there is a reject at the customer then your current controls are not effective and the PFMEA should be reviewed.
If you make a process change then the impacts of the change should be reviewed in the PFMEA.
Even if the review results in no change to the PFMEA, it may be good practice to record that the PFMEA has indeed been reviewed for the issue and no change made. This is documented evidence that the PFMEA is live and reviewed for all issues.
 

jkittle

Involved - Posts
#3
Re: When to Update PFMEA

I guess my question would be if the defect was produced and went undetected by the supplier and you made no change to your PFMEA then you must have not done a very good corrective action that wouldn't have affected your detection number or occurrence number.

Jerry
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#4
Re: When to Update PFMEA

I guess my question would be if the defect was produced and went undetected by the supplier and you made no change to your PFMEA then you must have not done a very good corrective action that wouldn't have affected your detection number or occurrence number.
Not only that, if it occurred, and you never expected it to occur before, it should be a new failure mode line item. If it was in the FMEA, you may have an opportunity to update the frequency...:cool:
 

Jim Wynne

Staff member
Admin
#5
Re: When to Update PFMEA

If there is a reject at the customer then your current controls are not effective and the PFMEA should be reviewed.
There is nothing in evidence to positively indicate that the OP's current controls are not effective. We don't know the definition of "effective" that's in use.

If you make a process change then the impacts of the change should be reviewed in the PFMEA.
Even if the review results in no change to the PFMEA, it may be good practice to record that the PFMEA has indeed been reviewed for the issue and no change made. This is documented evidence that the PFMEA is live and reviewed for all issues.
Yes. :agree1: Review is definitely in order--even if the review is based on the understanding that a single escape isn't worthy of changing anything--and there should be a record of the review.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
absolutely Jim.
without understanding the specifics of the fmea (which is often only guesses not analytically or empirically determined) we can make no assumptions about the efffectiveness.

we can't guarantee perfection.
what is/was the probability of occurence?
what is the detectability?
how were they determined?
what was the actual escape rate?

these are all things we must know.
 
P

prototyper

#7
Re: When to Update PFMEA

There is nothing in evidence to positively indicate that the OP's current controls are not effective. We don't know the definition of "effective" that's in use.
I was not suggesting that the OP's current controls are ineffective. The question was, under what circumstances should the FMEA be reviewed!
 
A

alebrijes

#9
Hi :bigwave:

I will apreciate if somebody can tell me what is the difference between method control defined in the FMEA vs. Control Plan. The method control in the Control Plan is for the product & the FMEA consider only for the process ?
 

Jim Wynne

Staff member
Admin
#10
Hi :bigwave:

I will apreciate if somebody can tell me what is the difference between method control defined in the FMEA vs. Control Plan. The method control in the Control Plan is for the product & the FMEA consider only for the process ?
The PFMEA (which precedes the PCP chronologically) has fields for current process controls (prevention controls and detection controls). Depending on the output of the PFMEA process, they could change, but ultimately the existing or new control(s) will be transferred to the control plan. In other words, the controls shown on the PFMEA and PCP will normally be the same.
 
Thread starter Similar threads Forum Replies Date
H Corrective Action: When to update the Process FMEA (PFMEA) FMEA and Control Plans 15
J When to update a PFMEA (Process FMEA) FMEA and Control Plans 17
B Update our PFMEA after Supplier updates their PFMEA? FMEA and Control Plans 4
Ninja Windows 10 100 % disk use after update Coffee Break and Water Cooler Discussions 21
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 2
M Do we need to create a new CER or can we just update the existing CER EU Medical Device Regulations 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
F Software development plan for SW update IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational Update on ISO TC 210 JWG 1 activities Medical Device and FDA Regulations and Standards News 0
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
M Informational US FDA Final and update guidances – Software Medical Device and FDA Regulations and Standards News 2
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational Update from GOV.UK – Regulating medical devices in the event of a no-deal Brexit – UK Responsible Person Medical Device and FDA Regulations and Standards News 0
M Informational Device Shortages Update – The US FDA Announces Two New Innovation Challenges on Device Sterilization Medical Device and FDA Regulations and Standards News 0
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 7
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Digital Health Update: Mid-Year Update on Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Device Shortages Update: Challenges to encourage the development of new approaches to device sterilization Medical Device and FDA Regulations and Standards News 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Is it compulsory to update the obsolete GMDN codes in ARTG? Other Medical Device Regulations World-Wide 4
M Informational USFDA – Digital Health Update: The FDA Announces an Opportunity for Test Case Volunteers for the Test Plan for the Software Precertification Program Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Guidance update – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD) Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
E Gamma Sterilization Product Update Manufacturing and Related Processes 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
B IEC 62304 - Update Checklist IEC 62304 - Medical Device Software Life Cycle Processes 2
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
C Do we need to make a new OFI (Opportunity for Improvement) for each document/form we update? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Digital Health Update – New actions and documents Medical Device and FDA Regulations and Standards News 0
M FDA News Digital Health Update: USFDA Report on Non-Device Software Functions Now Available Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
Marc Software Update 23 November 2018 Forum News and General Information 1
M Medical Device News Joint Action On Market Surveillance Of Medical Devices (JAMS) Releases Progress Update EU Medical Device Regulations 0
Marc Attachment List Update - 2018-11-16 Forum News and General Information 0
K Medical Device Software Update in Field of AIMD IEC 62304 - Medical Device Software Life Cycle Processes 1
M Medical Device News Health Canada update - Applications for Medical Device Investigational Testing Authorizations Canada Medical Device Regulations 0
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0
M Medical Device News TGA update 26-09-18 - Medical Devices Safety Update, Volume 6 September 2018 Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
S How to enforce my colleagues to update SOPs? Document Control Systems, Procedures, Forms and Templates 4
M Medical Device News Health Canada update 28-08-18 - Licensing Requirements for 3D-Printed Devices Canada Medical Device Regulations 0
Marc 2018 Software update - Donations Appreciated Forum News and General Information 21
J Update Technical File for EU Class IIa Medical Software Products EU Medical Device Regulations 3
L Re-calibrate after software update? Calibration Frequency (Interval) 3
W EU GDPR General Data Protection Regulation - What we need to update for our QMS EU Medical Device Regulations 10
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Similar threads


















































Top Bottom