Verification of Corrective Actions based on Quantities

beaser3

Involved In Discussions
#1
Hi,

My company is working on improving our 8-D process and one area that we feel we need to strengthen is the verification process. When the issue is part quality related, different 8-D team leaders base their closure off of different things. Some use 3 runs to verify (regardless of run size) some use a percentage of parts based off of EAU quantities, some say one run is enough, etc. I am wondering if anyone has any best practices that they could share on this topic?

Thanks in advance.
 
Elsmar Forum Sponsor

Emmyd

Involved In Discussions
#2
It depends, there is not a standard quantity that we use to release from containment. We see how serious the issue is for our customer and we base the added inspection quantity/time based on that. Sometimes it is one or 2 runs, sometimes a quantity. If we have had multiple rejections in the past for the same issue (say oily parts) we may change our processes to always wipe parts. Sometimes our customers specify how long or how many pieces. It really depends on the situation, the cost of the rejection and the impact to the customer.
 

Miner

Forum Moderator
Staff member
Admin
#3
While inspection results are definitely acceptable, you are not limited to them. You could also use the results of SPC and capability studies.
 

Jim Wynne

Staff member
Admin
#4
Don't get me started. Oh, wait--you did get me started. :bigwave: IMHO, the execrable 8D format should be taken out in the woods and put out of its misery. It just begs for ambiguity and subjective reasoning. Some tips:


  1. Be judicious in your use of CA requests. If you require a PPM level (another thing I hate) of your suppliers of say, 200, don't demand CA for an incident that doesn't break the PPM threshold. You can't, on the one hand, say that a certain level of defects is acceptable and then on the other hand demand CA for an obviously one-off incident.
  2. Look carefully at the identification of the root cause and what was done to stop it from happening or somehow neutralize it. That's what you want to know, after all. Does it make sense? Has the supplier demonstrated that the cause can be turned on and off?
  3. Don't make judgments on things you're not qualified to evaluate. If the supplier's response reads like Mandarin to you (and you don't speak or read Chinese), you're probably not qualified to sit in judgment. Get someone who is.
  4. There is no such thing as a "best practice" that will fit all situations. Complex problems require special, knowledgeable appraisal. You can't look in a reference book to find an answer.
  5. If you can't trust your suppliers to do conscientious CA, you need different suppliers or you need to make allowances when you have no influence.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#5
The verification 'quantity' should be based on the defect rate and/or cycle of the excursion. That is really the only way to determine if the Problem has actually been eliminated or reduced.

Other responders are correct that there is no one single mathematical rule that can be applied. We must apply the correct statistical thinking. And the correct physics thinking in understanding the causal mechanism and understanding that the proposed solutions will prevent re-occurrence of that causal mechanism.

A low defect rate will require higher sample sizes.
For defects that cycle, the control chart should demonstrate a minimum of 3 full cycle time periods before closing the action.
 

somashekar

Staff member
Super Moderator
#6
The applied corrective action when based on a process change, you will be interested to see the effectiveness of stability of new established process. This may depend on your consumption and the MOQ and your agreement with the part supplier.
If you want him to process the large quantity and make to you several deliveries, then in reality all the deliveries combines to one run. So it comes down to your risk evaluation and time should not be a limiting factor.
 

beaser3

Involved In Discussions
#7
Hi Jim,


I agree with your comments. The question is actually regarding our corrective action verifications for issues noted by our customers so we would be the supplier. I think, as stated by others, the verification will be dependent on situation but wanted to see if there is another, more standardized way to look at it.

Thanks to all for the responses!
 
Thread starter Similar threads Forum Replies Date
K Paperless Corrective Actions - Sign Offs for Responsibilities such as Verification Document Control Systems, Procedures, Forms and Templates 32
P Corrective Action Verification for Low Volume Production Nonconformance and Corrective Action 3
C Verification of CA (Corrective Action) for infrequent job? Nonconformance and Corrective Action 5
P Is special CA (Corrective Action) verification step necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
J Corrective Action Effectiveness and Results Verification Question Nonconformance and Corrective Action 5
A CPA (Corrective and Preventive Action) Verification and Validation Process Steps Nonconformance and Corrective Action 9
M Using Statistics for corrective action verification activities Statistical Analysis Tools, Techniques and SPC 8
A Root Cause Verification - Corrective Action Effectiveness, or Root Cause Verification Problem Solving, Root Cause Fault and Failure Analysis 24
Q Sampling method for Distributor verification activities EU Medical Device Regulations 1
D Design Verification Sample Size vs Repeats Statistical Analysis Tools, Techniques and SPC 9
S IEC 62304 - Software verification cost IEC 62304 - Medical Device Software Life Cycle Processes 3
T Laboratory Verification after validation ISO 17025 related Discussions 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
T Calibration or Verification -> Cm and Cmk, etc. Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
NDesouza Verification of Supplier RCCAs Nonconformance and Corrective Action 5
I IATF 2016 - 8.5.1.4 Verification after shutdown due to COVID19 Process Maps, Process Mapping and Turtle Diagrams 1
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
G Supplier flowdown verification of tests and revisions Supplier Quality Assurance and other Supplier Issues 0
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Calibration or Verification? What terminology to use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Bev D Verification and Validation of Measurement Systems Misc. Quality Assurance and Business Systems Related Topics 0
A Our auditor told if we didn't have a patent we would have to do a validation or verification ISO 13485:2016 - Medical Device Quality Management Systems 6
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
D Design Verification - Is testing required? Design and Development of Products and Processes 5
J Verification of purchased product / Alexa as a medical device ISO 13485:2016 - Medical Device Quality Management Systems 6
C Machine Verification Plan Manufacturing and Related Processes 2
A What to do when 100 % verification is not 100 % Manufacturing and Related Processes 5
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
R Design verification for interim design outputs - sampling rationale ISO 13485:2016 - Medical Device Quality Management Systems 2
B Verification/release medical device modules Other ISO and International Standards and European Regulations 7
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
Ed Panek Label verification and validation US Food and Drug Administration (FDA) 5
D Testing to failure for design verification Reliability Analysis - Predictions, Testing and Standards 11
D Supplied item design verification Supplier Quality Assurance and other Supplier Issues 5
Ronen E A Rational Basis for Design Verification Design and Development of Products and Processes 5
V Which batches should or could be considered for design validation and design verification? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Supplier related drawings and verification of process requirements - Source Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Medical Device Design verification sample prototype Other Medical Device and Orthopedic Related Topics 14
I Medical device Validation/Verification template ISO 13485:2016 - Medical Device Quality Management Systems 1
G KPC & KCC verification and updates FMEA and Control Plans 15
APHX02 Thread Roll Process Verification w/in AS9100 (i.e. BSP-F-69/AS8879) Manufacturing and Related Processes 2
R Plan to Volvo Cars for capacity verification in Phase 3 of PPAP Customer and Company Specific Requirements 3
F AS9100 D - Verification of purchased product - Sheet metal and aluminum extrusion stock AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Prashant G AS9100 Requirement - Verification of characteristics results with drawing requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13

Similar threads

Top Bottom