Example of a P-Diagram for Process FMEA - Uncontrollable noises

Sleepy Cat

Registered
If I create PFMEA with 6M, I don't know how to write the following items for "Method".
Step2 Process Step - Process Work Element
Step3 Function of the Process Step / Product Characteristic - Function of the Process Work Element / Process Characteristic
Step4 Failure Mode (FM) of the Process Step - Failure Cause (FC) of the Work Element
For example, is the following correct?
Step2 Mixing - Stirring speed according to the work instruction
Step3 Uniform agitation - the work instruction instructs the procedure to achieve uniform stirring
Step4 Uneven mixing - Incorrect or insufficient instructions, damaged or dirty, not near the operator
 

Bev D

Heretical Statistician
Leader
Super Moderator
Sleepy Cat: Have you had any formal training on PFMEA? Are you working on this alone or with a trained team? I ask because your example is a “hot mess” and I don’t say this to be mean but to be clear that this example is not how a PFMEA is intended to be.

The basic method of FMEA is to:
1. List the functions of the process (not ‘steps’ in a process)
2. List the failure modes of the functions (full failure, partial failure, intermittent failure and/or unexpected failure as appropriate)
3. List the Effects of each failure mode.
4. List the potential causes of each failure mode.
The ‘6Ms’ (Man, Machine, Method, Measurement, etc) is helpful in thinking about causes of failures but it is not required or even appropriate to always list causes in all categories

So, “uneven mixing” is not a step, it is a failure mode of mixing. Now think about what the effect of uneven mixing is. How severe is uneven mixing? Next think about how uneven mixing can occur. This is often a multi step thing (like dominoes in a line falling). For example uneven mixing can occur because the mixing time is too short; how can the mixing time be too short? Then you need to think about how you might prevent, detect or mitigate uneven mixing…

FMEA is not a form you fill out. It is a guide to developing robust processes (and designs).
FMEA is complex and requires substantial training, coaching and experience.
 
Thread starter Similar threads Forum Replies Date
O Example of Turtle Diagram with Risk/Opportunities General Auditing Discussions 1
C IT Internal Audit Turtle Diagram example wanted Internal Auditing 3
B Example Turtle diagram needed Process Maps, Process Mapping and Turtle Diagrams 3
Anerol C Corrective Preventive Action Turtle Diagram example needed Process Maps, Process Mapping and Turtle Diagrams 6
D Section 10: Improvement Best example from auditor perspective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T AS9100 Process Sequence and Interaction Map Example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
GreatNate Looking for Hazardous Material Management Plan example or HMMP assessment checklist Occupational Health & Safety Management Standards 6
S AS9100 Supplier Audit Checklist example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
F Interpretation of 60601-1 Figure J.5 (Isolation, example 5) for a rechargeable, battery operated device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Customer Survey Example - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
D 62304 code review, unit test, integration test example IEC 62304 - Medical Device Software Life Cycle Processes 2
K Definition and Example of Shelf life, Expiry date, Expected service life and Lifetime EU Medical Device Regulations 6
Anerol C In Charge of Safety - New- Safety program Example Occupational Health & Safety Management Standards 6
Eva lee Which is the range for the validated batch size(for example ±5%, 10%) is acceptable? Manufacturing and Related Processes 8
A Control plan for IATF - example? FMEA and Control Plans 1
J Drawing Example Request: Inspection Section Plane of Aluminum Casting Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A Attribute , for example C chart Statistical Analysis Tools, Techniques and SPC 16
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 20
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 5
optomist1 Paynter Chart Example APQP and PPAP 1
M Data Protection and Privacy Policy - looking for a template/example EU Medical Device Regulations 1
A Verification protocol example Design and Development of Products and Processes 2
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
Q Example of the Risk Template Document Control Systems, Procedures, Forms and Templates 4
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
D Calibration Process Flow Map Example Wanted General Measurement Device and Calibration Topics 3
Dobby1979 Redacted 510(k)s - Example wanted Document Control Systems, Procedures, Forms and Templates 17
F Hi friends, can anyone show me an example of a procedure for ISO 13485 6.4.1 Work Environment? ISO 13485:2016 - Medical Device Quality Management Systems 4
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
M An example of risk analysis of class I MD ISO 14971 - Medical Device Risk Management 36
D Monitoring and measuring resources - Example of how section ISO 9001 7.1.5 would apply to a manufacture of software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Validation of existing equipment - Risk based approach example ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO/TS 22163 Item 5.2.4 Safety policy - Example wanted Other ISO and International Standards and European Regulations 2
F Internal Audit - Procedure example Internal Auditing 5
I Functional Safety Analysis/Report Example IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
H Man Hour Plan 145.A.30 example needed EASA and JAA Aviation Standards and Requirements 0
R Real Example of a currently marketed Procedure Pack CE Marking (Conformité Européene) / CB Scheme 1
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
MichaelDRoach Oganization's Self Declaration of Conformance to ISO 28000 wording example wanted Supply Chain Security Management Systems 1
J ISO 13485 8.4 Analysis of Data - Procedure example ISO 13485:2016 - Medical Device Quality Management Systems 1
S Question about a basic additive variance/tolerance example Quality Tools, Improvement and Analysis 2
N ISO 9001: 2015 - Example standards policies, procedures, acknowledgements and checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
supadrai How does the FDA count violations of, for example, misbranding? (Medical Devices) Other US Medical Device Regulations 1
E Labware cleaning validation protocol example Qualification and Validation (including 21 CFR Part 11) 1

Similar threads

Top Bottom