When can you stop root cause analysis - Is the answer never?

R

rootcrazy

#1
Are there any guildelines on when root cause analysis can be stopped...or is the answer never?

Say you have a product where you weren't doing complete testing. Because of this some small level of rejects reached the customer.

You now add a new test that prevents the rejects from reaching the customer. But, the 8D process requires that you find the root cause of that failure mode.

After going so far in root cause analysis, you find the problem is a random defect, and the defect level is in the low ppm range. But, you haven't been able to find the exact location of the defect or what process step is causing the defect. Knowing that the defect is random, it is in low ppm level, you have general programs to reduce defects, you can test out the defect, and that the defect doesn't come close to being your number one yield loss, can you close root cause analysis?

Are there any publications that provide guidelines on this?
 
Elsmar Forum Sponsor
D

DICKIE

#2
Root cause analysis does not always result in the definitive root cause. The process you used seems to me to be technically correct. I think that it can be closed sighting random variation.
 
L

Lety Broome

#3
I would apply the rule in 4.14 "...shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered". If you have reduced the problem and eliminated the risk, work on something more significant.

If you are QS compliant, apply the rule in 4.13.2.1 for nonconforming product "The supplier shall quantify and analyze nonconforming product and establish a prioritized reduction plan..."

Eliminating a problem is great, when it is "normal". It sounds like it is no longer "normal".
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#4
What is a reasonable risk?
What level of resources can be committed to this problem?
What is required of your Customer?

In my experience, CAs are issued too liberally. I believe this is what creates many closure problems. People get them and don’t know what to practically do about the problem. All systems and processes produce some level of nonconformance. Sometimes it matters. Sometimes it does not. This is where managed risk needs to enter the equation and the reasonable expectations of your customer. This should suggest the level or degree of resources that should be spent on rectifying the situation.

Using the 5 WHYs or 8D are good tools. I personally try to trace the root cause back to a system/process parameter or a Quality Program oversight. I believe in the 94/6 principle, that most problems are caused by the system/not the people.

Regards,

Kevin
 
D

Dan Larsen

#5
I agree with Kevin. CA's should be reserved for systemic problems, for example a recurring nonconformance of a particular type. If you follow this rule, then the root cause analysis is more likely to get to a system (rather than people) problem. When you overuse the CA system, it has a tendency to become a nuisence and often ineffective. Sound root cause analysis is usually the first thing that suffers.

As to when to stop root cause analysis, I generally suggest you keep going until you get to a system issue. If the root cause analysis was insufficient, the audit of the action taken should show you that, and a new CA can be initiated.
 
G

Geraldk

#6
I, would agree, once you reduce the PPM to a very low level ie;0-15, and it is a random occurence, you should close the 8D. Having said that, if you have the budget, or your customer will not accept the risk of that level of quality, you should try to investigate some more.

regards,

Gerald
 
A

Al Dyer

#7
To add to Kevin and Dan,

In these days of lean manufacturing we have to allocate our resources wisely and try to make sure there will be a tangible ($$$) benefit to the expected outcome. It comes down to defining what type of situations really need to go through a formal and costly corrective action process.

Also as said before, it is the systemic issues that need to be addressed through the formal corrective action process. Hopefully, if their is a robust system in place that constantly uses that wonderful tool of ongoing FMEA review, issues for corrective action can be determined.

All that said, there is the dreaded customer complaint that requires a formal response. They want an answer and they want it now.

We are now in crunch mode even if it is an isolated incident. Don't skimp on the basics, go through the process of containment, brainstorming, fishboning etc... and all important, the 5 why's. Now is the time to physically visit the customer and show that they are important to us.

I have found that having a scheduled visit to each customer that includes interraction with line personnel, the lower the complaint rate. I believe that this is because most complaints start at the production floor and work their way upwards. Keep the line people happy, show you care about them and your fallout rate can be decreased.

(Some aspect of human nature that other members of the forum can expand upon)

ASD...

[This message has been edited by Al Dyer (edited 28 March 2001).]
 
Thread starter Similar threads Forum Replies Date
M Supplier Audits - Stop Wasting Everyone's Time! General Auditing Discussions 15
qualprod Records where apply and stop recording everything? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Marc A 20 Hour Non-Stop Flight - (October 2019) Travel - Hotels, Motels, Planes and Trains 19
M Informational FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distr Medical Device and FDA Regulations and Standards News 0
N What subcommands can be used with "Stop" in Minitab 18? Using Minitab Software 8
P Terms, "Yard Holds", and "Stop Ships" in TS 16949 IATF 16949 - Automotive Quality Systems Standard 1
smryan Excel Printing Glitch - How to STOP Printing One Cell per Page Excel .xls Spreadsheet Templates and Tools 10
Anerol C Procedure to stop a machine due to safety Occupational Health & Safety Management Standards 4
N How to Stop Packaging Choice Mistakes on a Form Other Medical Device Related Standards 6
Z When to stop Post Market Surveillance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C ISO 14001 Emergency Stop Information ISO 14001:2015 Specific Discussions 4
S How many production runs will it take for SPC monitoring to stop? Statistical Analysis Tools, Techniques and SPC 10
Marc Ray Harryhausen - The Stop Motion Animation King Coffee Break and Water Cooler Discussions 4
N How to stop this abuse..... Imported Legacy Blogs 12
F When TSA stop to issue new Foreign FAA Part 145 Repair Station? Federal Aviation Administration (FAA) Standards and Requirements 1
L When does Medical Device New Product R&D stop and Design start? Design and Development of Products and Processes 6
B Delay in Payment Posting - Customer would like to stop paying monthly amortization Customer Complaints 5
B Can we stop Customer Surveys as they are generating low return rates ? Customer Complaints 16
G Customer Property Cl. 7.5.4 - Where does ISO 9001 stop and ISO 27001 start? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
Marc Stop Online Piracy Act (SOPA) and the PROTECT IP Act (PIPA) After Work and Weekend Discussion Topics 21
1 Stop Ship/Build or something like a Quality Alert template or procedure example Document Control Systems, Procedures, Forms and Templates 5
Marc What happens when computers stop shrinking? After Work and Weekend Discussion Topics 3
Anerol C What protocol do you follow to stop the production line? Nonconformance and Corrective Action 9
P Regulations concerning Calibration of Stop Watches used for Testing Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Press Brake Tooling / Back Gauging - Holes for the back stop instead of the Part Edge Manufacturing and Related Processes 8
C Calibration Of Stop Watch using the NIST Clock General Measurement Device and Calibration Topics 4
D Process Flowchart - Can the Flowchart of one Process have two END (Stop) Points Process Maps, Process Mapping and Turtle Diagrams 5
Wes Bucey It's Friday - don't stop the job hunt! Career and Occupation Discussions 2
Stijloor Stop Forum Spam - Helpful site? After Work and Weekend Discussion Topics 1
D Production start after stop IATF 16949 - Automotive Quality Systems Standard 12
Sidney Vianna Aerospace auditors are told to stop soft grading NC's. Or else! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 42
D Definition Stop Gap - Definition - What does "stop gap" mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
M Can I Stop the Internal Audit Program? Internal Auditing 21
Manix Ideas On Wiring Configuration Control - Help STOP a Non Conformance! Manufacturing and Related Processes 7
Sidney Vianna Electronic wedge brakes will change the way we stop World News 6
ScottK Foreign Languages in the workplace - can you stop it? Career and Occupation Discussions 14
C First Audit Stop - Employees Washroom - Learn all you need to know about a company General Auditing Discussions 83
Marc Will the weather service be forced to stop giving weather information for free? World News 4
J IATF 3th auditor training course stop? Training - Internal, External, Online and Distance Learning 2
A Supplier 8D does not stop the problem - Critical defects - How to make 8D effective? Supplier Quality Assurance and other Supplier Issues 4
Sidney Vianna ISO/IEC standard for "one-stop accreditation" to boost cross-border trade ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
S Huh? What is "Stop Shipment Notification" IATF 16949 - Automotive Quality Systems Standard 6
N Why do 'we' and ?our? QMS?s stop working? What are the Failure Modes? Misc. Quality Assurance and Business Systems Related Topics 62
M High Cpk's and Control Charts - Is it justified to stop using control charts? Capability, Accuracy and Stability - Processes, Machines, etc. 7
Marc Stop Watch Calibration Reality Check General Measurement Device and Calibration Topics 22
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
T Root Cause Failure Analysis - Not following Customer packaging Specification Problem Solving, Root Cause Fault and Failure Analysis 5
D Root Cause for Missed Audits Misc. Quality Assurance and Business Systems Related Topics 1

Similar threads

Top Bottom