Is it possible to reduce FMEA Occurrence and Detection Ranking after corrective action taken for customer complaints?

Ashok sunder

Ashok sunder

Starting to get Involved
#1
#1
sir,
I have small clarification on PFMEA detection & occurrence rating .If customer complaint arises we have take corrective action and the same action will be included in PFMEA. continuously six months the corrective action was monitored. Its is possibility to reduce the occurrence and detection value?
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
Pjservan

Pjservan

Involved In Discussions
#3
#3
It depends on the action taken. The fact that it has not repeated itself may have an effect on your occurrence levels per Andy's comments above but not necessarily on the detection levels.
 
Ashok sunder

Ashok sunder

Starting to get Involved
#5
#5
Pjservan said:
It depends on the action taken. The fact that it has not repeated itself may have an effect on your occurrence levels per Andy's comments above but not necessarily on the detection levels.
Click to expand...
Thank you,
We have take corrective action to prevent one of the cause of failure mode, at that time we have change the occurrence value
 
somashekar

somashekar

Leader
Admin
#6
#6
By logic, yes it can be reduced. It all depends upon the technical team and the expertise you have used in the PFMEA formulating. You should rather address your FMEA periodically and check if you can have a new low and the inputs can be from various areas, corrective actions being a significant one.
 
Bev D

Bev D

Heretical Statistician
Leader
Super Moderator
#7
#7
What was the actual occurrence rate of the failure you took corrective action on and was it higher or lower than that on your FMEA?
Do you have proof in the form of a control chart that the failure rate actually decreased after the corrective action was implemented?
Was your original occurrence rate based on actual data or was it a 'guess' (some call this engineering judgment)
Was this an expected or unexpected failure?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L Reduce risks as far as possible - Quartz Crystal ISO 14971 - Medical Device Risk Management 11
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
S What to do if no further control possible to reduce the OHS risk? Occupational Health & Safety Management Standards 16
S Possible termination of MDD Certificate CE Marking (Conformité Européene) / CB Scheme 4
M It is Possible to apply a wall plug power adapter to provide power from the actuators of a dialysis chair or hospital bed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Is it possible to obtain FDA clearance (510k) without meeting QSR? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
MaHoDie Is it possible to assign medical software to security class A (according to IEC 62304)? EU Medical Device Regulations 8
B SAE J 524 Pressure Test/Possible conflicting requirements? Manufacturing and Related Processes 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
S Operation of possible rework in control plan FMEA and Control Plans 8
J Impact Testing--Is conversion between Izod and Sharpy Possible? General Measurement Device and Calibration Topics 3
G One-person QMS - possible? ISO 13485:2016 - Medical Device Quality Management Systems 18
L Significant subcontractor update, still under MDD Certification, possible? CE Marking (Conformité Européene) / CB Scheme 3
C Narrow definition of IMTE or calibration possible? ISO 13485:2016 - Medical Device Quality Management Systems 8
J EC Certification transfer from CMO to Legal Manufacturer Possible? CE Marking (Conformité Européene) / CB Scheme 0
K Silver Plating corroding possible during SMT Manufacturing and Related Processes 10
K Is it possible to avoid the OQ? ISO 13485:2016 - Medical Device Quality Management Systems 20
G Special 510K possible? Only the packaging has changed Other US Medical Device Regulations 0
supadrai Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application? US Food and Drug Administration (FDA) 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
M Informational EU – Possible EUDAMED delay Medical Device and FDA Regulations and Standards News 3
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
dhuot1990 USP 41 Hanging Scale - Is it possible to make a hang scale adhere to USP41 Standards? ISO 17025 related Discussions 3
F Apple Watch is not a medical device. How can this be possible? CE Marking (Conformité Européene) / CB Scheme 1
qualprod ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
E Is it possible to start an ISO 9001 QMS from scratch (Really) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
a_bardi Is it possible to exclude internal audit from qms scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G ISO 9001:2015 - Is control possible with Excel adaptable measurement sheets? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
S Indications for Use - Is it possible to have a different indication for use EU Medical Device Regulations 3
C %GRR <10% not possible. How to get approval by auditor? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
I Is risk acceptability really needed if all risks must be reduced as far as possible? ISO 14971 - Medical Device Risk Management 6
M Is Automated Internal Auditing Possible? Internal Auditing 13
A Integrated Management Systems - ISO 50001 and ISO 9001 possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Is it possible to receive EASA STC within 48 hours after modification? EASA and JAA Aviation Standards and Requirements 1
3 Israel: 1 Medical Device, Multiple Registrations = Possible? Other Medical Device Regulations World-Wide 3
Marc Yahoo probes possible huge data breach - BBC News - 2016 World News 1
Marc Yahoo probes possible huge data breach World News 0
S Preparing a Root Cause Report - Possible Root Causes Document Control Systems, Procedures, Forms and Templates 11
M Future of ISO 14971 - Possible revision? ISO 14971 - Medical Device Risk Management 9
M Is IEC 60601 compliance possible when only generic power-supply is specified? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Is it possible to have more than one authorized representative in Saudi Arabia? Other Medical Device Regulations World-Wide 6
Y Is it possible to check the authenticity of a CFDA registration certificate? China Medical Device Regulations 7
T Reduced Audit days when UPGRADING from AS9100 to TS16949 - Is it possible? IATF 16949 - Automotive Quality Systems Standard 2
Ajit Basrur Is Biocompatibility study performed on medical devices for possible contaminants? Other Medical Device Related Standards 4
B Subsidiary - No Managing Director - Is ISO 9001 Certification Possible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom