Process Failure Mode Effects Analysis (PFMEA) Basics

S

sureshramadurgam

#1
#1
Hello every one out there,

i am new to this discussion forum.dont know whether i am posting this question to all. but my request is please help me in preparing PFMEA and control plan for the company which i am working. This is my own initiativeness to prepare fmea and control plan for the company.please help me i am in the begining stage.
 
Elsmar Forum Sponsor
Tom W

Tom W

Living the Dream...
#2
#2
Re: process failure mode effect analysis

Well welcome to the Cove...

If you complete a search for FMEA and/or Control Plan you will find an incredible amount of information on both. Click on the search feature in the blue bar above the forum and you should be able to find what you are looking for. Please make sure to ask more questions if you do not understand or cannot find what you want.

I am sure a moderator or two can help you get started.

Again - welcome and come back often.
 
Stijloor

Stijloor

Staff member
Super Moderator
#3
#3
Re: Process Failure Mode Effects Analysis (PFMEA)

sureshramadurgam said:
Hello every one out there,

i am new to this discussion forum.dont know whether i am posting this question to all. but my request is please help me in preparing PFMEA and control plan for the company which i am working. This is my own initiativeness to prepare fmea and control plan for the company.please help me i am in the begining stage.
Click to expand...
Hello and welcome to The Cove Forums! :bigwave::bigwave:

Thank you for your post.

I did an advanced forum search on PFMEA and found this.

I also found some documents in the Post Attachments List. Look here.

You may want to start there. If you have some specific questions about PFMEA, please post them here. We are happy to help. And you may be able to assist others. We're all about sharing knowledge and experience here. :agree1:

Hope this helps.

Stijloor.
 
G

gholland

Involved In Discussions
#4
#4
One thing to remember is that in a FMEA you are looking for harms to the patient/caregiver. In the case of pFMEA you must assume that your design is perfect and that something in the process causes not only a failure but a failure that will cause a harm to your end user/patient.

You will want to take each step in the process separately and evaluate them in terms of 'what can make the output of the process harmful?' Your control plans will then be driven off of your FMEA results.

For example I had a project where a machine was cycling once every few seconds. A piece of the machine was sliding back and forth and had the potential to cause aluminum shavings. These shavings, while very small, could cause an embolysm if infused into the patient as the process that was considered had the potential to introduce these shavings into a fluid path. The FMEA identified this and drove a material change from aluminum to plastic for this part.

It is helpful to have a process flow diagram while doing this.

:2cents:
 
P

pmwong

Involved - Posts
#5
#5
Hi,

It is also to have some of the basics:

1) A copy of the NEW APQP 2nd Edition and the FMEA 4th Edition Reference manual where you can learn from the start. (ensure that you know your customer requirements, whether you are using customer specified format or your own format ) as this is important.

2) Before preparing any FMEA and Control Plan, you will need to have a basic process flow of your internal process activities, which you can number from 1 to 10 for example.

3) Where to start? Start from process flowchart, follow by FMEA and then Control Plan.

4) You would need to specific your parts manufactured as different industries have differ failure mode and control points.

5) The rest can search at this forum for formats that you need :)
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Relation b/n Process Failure Mode RPN Value and the associated Process Failure Cost FMEA and Control Plans 3
P Problem with "failure mode? interpretation in PFMEA (Process FMEA) FMEA and Control Plans 8
S Basic PFMEA (Process Failure Mode Effects and Analysis) Questions FMEA and Control Plans 22
kedarg6500 Potential Failure Mode - Mix Charge for Hardness - Casting Process FMEA and Control Plans 1
A Process FMEA - Help in deciding "detection ranking" of a failure mode FMEA and Control Plans 5
Y Design (DFMEA) and Process (PFMEA) FMEA Failure Mode Identification Design and Development of Products and Processes 8
P Root Cause for a Process Validation Batch Failure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Auditor Sued for Damages, for Failure to Warn of Process Risk Misc. Quality Assurance and Business Systems Related Topics 32
M Process Controls - Wood Glue Adhesive Failure Manufacturing and Related Processes 7
V Common Failure Modes for a Product/Process Line ISO 14971 - Medical Device Risk Management 1
V Examples for failure modes of Design & Process FMEAs FMEA and Control Plans 5
M FMEA for Drilling Process - What kind of failure can happen during drilling process? FMEA and Control Plans 8
R Lyophilization: Causes of process failure? Manufacturing and Related Processes 3
M PFMEA (Process FMEA - Potential Causes and Failure) - Operator's Role FMEA and Control Plans 11
M PAA (Process Assurance Assessment) vs. FMEA (Failure Modes and Effects Analysis) FMEA and Control Plans 3
Q FMEA (Failure Modes and Effects Analysis) and Control Plan Process Diagrams FMEA and Control Plans 3
J Updating a PFMEA (Process FMEA) after a Process Failure FMEA and Control Plans 3
R Failure analysis process or activity need to be audited? Internal Auditing 3
N PFMEA on lean tools - Failure modes of a PFMEA of the tool "implementation process", FMEA and Control Plans 6
M Family or individual PFMEA's (process failure modes effects analysis)? FMEA and Control Plans 3
G PFMEA failure modes for Process Function of Inspection/test FMEA and Control Plans 10
L Where should the Process Failure Form reside? Document Control Systems, Procedures, Forms and Templates 6
T Process FMEA (Failure Modes Effects Analysis) Severity Rating and RPN IATF 16949 - Automotive Quality Systems Standard 17
Q Process Correction vs. Corrective Action - Failure to React when Out of Control Nonconformance and Corrective Action 8
A Seeking Ideas: Raw Material Storage Process Failure Modes FMEA and Control Plans 3
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 4
LostLouie Manufacturer divorced from Design process, is he justified in design process deficiencies? ISO 13485:2016 - Medical Device Quality Management Systems 3
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
D Question regarding customer feedback process ISO 13485:2016 - Medical Device Quality Management Systems 3
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 5
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Error Proofing Label process Manufacturing and Related Processes 4
B New Release of CQI-12 Coatings Process (Revision 3- Release date- 7/2020) Customer and Company Specific Requirements 2
D Layered Process Audits - FCA 9.2.2 - Exemption Clause? IATF 16949 - Automotive Quality Systems Standard 5
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
Q Example Process orientation to the process leadership, management, goals (tasks of the top management) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Process Inspection -Sub assembly process inspection sheet Lean in Manufacturing and Service Industries 3
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
K Problems with process equipment ISO 13485:2016 - Medical Device Quality Management Systems 4
W Need for current design or process control FMEA and Control Plans 2

Similar threads

Top Bottom