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.
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
T

Tom W

#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

#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
J NCR- Failure of contract review process - NADCAP audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
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
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
F Is this misuse of the MRB process? Manufacturing and Related Processes 7
L Product and process Deviation procedure Manufacturing and Related Processes 1
Ch00Ch00 How to evaluate a process ? Document Control Systems, Procedures, Forms and Templates 3
M Implants made by Additive Manufacturing process approved by USFDA Other Medical Device and Orthopedic Related Topics 1
Q Process Key figures and reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Ch00Ch00 Evaluate a process - Issue number Lean in Manufacturing and Service Industries 7
F Rules of process outsourcing in China China Medical Device Regulations 1
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
P Certification process for registered device China Medical Device Regulations 11
Melissa Process Validation of Rotary Heat Sealer Speeds Design and Development of Products and Processes 4
C Validation of process for releasing the UDI EU Medical Device Regulations 4
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 10
C Validation of process for production and servicing 5.7.1.5 API Spec Q1, 9th Edition Oil and Gas Industry Standards and Regulations 9
Z IA Construction Procurement Process Internal Auditing 3
H Risk Management Plan in agile process ISO 14971 - Medical Device Risk Management 14
DuncanGibbons Process flow & PFMEA for production planning and simulation activities? Process Maps, Process Mapping and Turtle Diagrams 7
N Help with understanding Process Controls Manufacturing and Related Processes 7
M VDA 6.3 – Workshop for Certified Process Auditor VDA Standards - Germany's Automotive Standards 2
C Process Consistency Manufacturing and Related Processes 5
I PFD (Process Flow Diagram) approach. Setup details as part of PFD? APQP and PPAP 5
K Business Process Flowchart Process Maps, Process Mapping and Turtle Diagrams 2
L Looking for Control Plan and FMEA Stamping process FMEA and Control Plans 2
J License renewal process in Iran Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom