Loss Prevention in ISO 9001:2000

D

Denis

#1
ISO 9000:2000 loss prevention

Hi,
I'm new to this group , so apologies if this has been previously explored.
We are working towards ISO 9000:2000 standard - already approved for '94.
Need opinions on how we are to address the loss prevention issue, section 8.5.3. Our business is semi conductors manufacture and we feel that conventional FMEA just will not work due to the infinite number of variables etc..

Any ideas on how we can go about addressing this part of the standard?
 
Elsmar Forum Sponsor
K

km2red

#2
How about a "generic FMEA"? One that catorgorizes one TYPE of product, but not every specific part number? (like a product family)?:rolleyes:
 
J

Jim Biz

#3
Contensious thoughts!!

Welcome to the group Denis :bigwave:

Guess I've often wondered why a number of folks really believe that FMEA (in one form or another) is mandated by the standards.

From your post - I would think many of the other "suggested" quantatiative data areas in 9004 such as market analysis/ process measurements/ self analysis data ( in house Cost of Quality data trends ) etc., could be used - in lieu of "formalized FMEA"

One local area presentation that I attended - led attendees to believe that there was frankly "NO OTHER way to satisfy the issue (this was in connection to the presenters offer to teach FMEA classes for those present.)

My thinking is that because the wording on 9004 - uses language terms of "SUCH AS" fault mode and effect analysis on the first suggestion line that everyone quits reading at that point.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Motorola uses FMEAs in the semi-conductor sector quite effectively. I'd post one but obviously that wouldn't be appreciated by them. I'm not sure why you:

> feel that conventional FMEA just will not work due to the
> infinite number of variables

In addition, FMEAs are only one avenue of addressing 8.5.3 - Or are you looking for a better tool because you're focusing on preventive action in your manufcturing only.

Remember, in whole the requirement reads much like this:
*****************
8.5.3 Preventive Action

Our organization determines action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of the potential problems.

A documented procedure is established to define requirements for

a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing preventive action taken.
*****************

As a last comment, if you're just trying to fulfill 8.5.3 - do a search here in the forums using the key word 'preventive'. There are a bunch of threads where we discuss preventive action.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Re: Contensious thoughts!!

Originally posted by Jim Biz

Guess I've often wondered why a number of folks really believe that FMEA (in one form or another) is mandated by the standards.
This is because, if you look closely, you will see that the ISO 9001 revision was strongly influenced by QS-9000. If you take a trip back into time to The Old Forum Archives (Note: Clicking the link will call up a pretty big - 350k - page) - and even within these newer forums - you will see that addressing the requirement in QS-9000 for predictive methods was, as a minimum, fulfilled by FMEAs.

Another 'preventive' issue is: If you react to a corrective action and part of that reaction is to review other products / processes where that 'error' may occur in, is this really a preventive action. I think the current agreement is that this is preventive even though the origin was from an 'error'.

Between auditors and registrars who are involved in both ISO and QS the 'recommendation' for an FMEA comes out. This is in part because of the limited number of tools which are predictive. Just to recall how pretentious the issue gets when you come to distinguishing predictive vs. preventive, remember this thread? http://Elsmar.com/Forums/showthread.php?t=687

This also came this weekend:

> Hi Marc,
>
> Thanks for your reply on loss prevention issue. The major difference
> between Motorola and us is that we actually grow the compound semi-
> conductor wafers for customer end use and conversion into workable devices.
>
> We effectively have a one step manufacturing process (growth of epi
> taxial wafers) completed in one step, controlled by Mass Flow Controllers
> via computer program.
>
> We have talked about performing FMEA on the actual processes
> involved in all the manufacturing stages as opposed to FMEA on the product.
>
> Our customers supply us with their design specifications and we make the
> wafers to their spec.
>
> Ultimately we are looking for a better tool to achieve a loss
> prevention mechanism.

The bottom line is you're looking for a predictive risk analysis tool to address loss prevention - a predictive methodology. In considering the FMEA I prefer a procsss FMEA as opposed to a product FMEA. In you case, I think a product FMEA would be a pain. I would insist on process FMEAs.

OK gang - Ideas on Process Loss Prevention Tools? I did some searches here and there's virtually nothing specific - other than with respect to FMEAs...
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Originally posted by km2red

How about a "generic FMEA"? One that catorgorizes one TYPE of product, but not every specific part number? (like a product family)? :rolleyes:
How about a process / operation FMEA? Is this what you have in mind?
 
D

Denis

#7
Thanks for the comments so far.

The most useful idea that we are now talking about is using FMEA on the process, coupled with an internal preventative and corrective action course.

I know that we would still be reacting after the event on some of the issues, but at least we can demonstrate our commitment to providing permanent corrective actions.

Hopefully, customers and third party audit bodies will recognise this.

Regards,
Denis
 
Thread starter Similar threads Forum Replies Date
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
M Informational FDA discussion paper – Consideration of Benefit-Risk Approaches for Weight-Loss Devices Medical Device and FDA Regulations and Standards News 0
M Loss of a Quality Record - FDA Inspection Records and Data - Quality, Legal and Other Evidence 4
H 8.4.2.4.1 Supplier Audit - Supplier with IATF certified loss IATF 16949 - Automotive Quality Systems Standard 4
BradM Sympathy to Wes Bucey and his family, loss of his wife Coffee Break and Water Cooler Discussions 20
Q Loss of Personnel - Root Cause Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
E Risk Analysis - Events which may cause to Data Loss ISO 14971 - Medical Device Risk Management 12
M Taguchi Loss Function Problem Misc. Quality Assurance and Business Systems Related Topics 2
RoxaneB Fighting Corporate Memory Loss Training - Internal, External, Online and Distance Learning 7
T Calibration Laboratory Temperature/Humidity goes out of tolerance due to Power Loss General Measurement Device and Calibration Topics 9
V Monitoring Specific Reasons and Categories of Yield Loss of Online Rejects ISO 13485:2016 - Medical Device Quality Management Systems 1
E US FDA Blood Loss Policy - Dislodged Hemodialysis Needle Other US Medical Device Regulations 3
Randy Loss of gravitational attraction (Weight loss for you PhD's) Coffee Break and Water Cooler Discussions 29
C Assembly Line Organization 17% Startup Loss - SMED (LCD TVs) Lean in Manufacturing and Service Industries 3
Marc Taguchi Loss Function example Misc. Quality Assurance and Business Systems Related Topics 4
S Incidence of Loss of Competency - Departure of a Knowledgable Employee Misc. Quality Assurance and Business Systems Related Topics 10
G Implementing Taguchi Loss Function in COQ - A Curious Case Misc. Quality Assurance and Business Systems Related Topics 1
M "Pet Project" Improvements - At a loss Lean in Manufacturing and Service Industries 23
Chennaiite What is the loss? A guy buys a chocolate from a shop worth 80 YEN Brain Teasers and Puzzles 20
bobdoering Toyota forecasts $8.6B loss, says 1 million sales will vanish World News 2
chris1price Loss of CE Mark - MHRA decided that they are not Medical Devices EU Medical Device Regulations 10
Jim Wynne GM Posts $15.5 Billion Second-Quarter Loss World News 0
K Cost Estimation of Sand Casting Process including the Pig Loss in estimation Manufacturing and Related Processes 7
H Rolled Throughput Yield (RTY) Loss - Can you measure in PPM? Six Sigma 3
Marc Ford posts its worst loss in history World News 8
Marc Ford Reports Loss of $5.8 Billion in 3rd Quarter World News 0
Marc Ford Has $1.19 Bln 1st-Qtr Loss on Job-Cutting Costs World News 15
Marc GM tried to mask its billion-dollar third-quarter loss with bright news World News 15
Marc The Loss of Manufacturing Jobs since 1999 - Will Unions make a Come Back in the US? Philosophy, Gurus, Innovation and Evolution 24
Marc GM plunges into $1bn quarterly loss World News 28
M ASTM Method for Light Loss Testing - Enclosures for the CCTV industry Various Other Specifications, Standards, and related Requirements 4
M Monetary Loss due to NonConformances - Who is liable? Nonconformance and Corrective Action 11
M How far does one go to protect quality and other records from "loss" Records and Data - Quality, Legal and Other Evidence 1
Geoff Cotton Taguchi quality loss function - How do I establish the 'Consumer Loss' element? Quality Tools, Improvement and Analysis 6
Marc Zero Defects & Taguchi Loss Function - ISO 9000 and the Zero Defects Philosophy Quality Tools, Improvement and Analysis 32
A AS9100D 8.1.4 Prevention of Counterfeit Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
K Counterfeit parts prevention - Audit Nonconformance - AS9100 8.2.2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
L Form-dependent position prevention control FMEA and Control Plans 1
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
R Operator's manuals as prevention design control FMEA and Control Plans 2
A AS9100 D Counterfeit Prevention Program - We just service parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
A AS5553B Counterfeit Prevention - Traceability requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Q Preventive Action - How to call the prevention when there is not a clause ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Creating together Standard Definition for Prevention and Detection FMEA FMEA and Control Plans 1
D GHG Emissions - Can a Prevention is better than Cure strategy help Imported Legacy Blogs 4
somashekar The REDACTED Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Occupational Health & Safety Management Standards 9
J What is Prevention in FMEA? FMEA and Control Plans 6
B Hot Rolled Steel Coil Rust Prevention Tests Manufacturing and Related Processes 3
K Are 'Work Instructions' a Detection Control or Prevention Control? FMEA and Control Plans 8

Similar threads

Top Bottom