7/18/2019 Prevention Fmea

http://slidepdf.com/reader/full/prevention-fmea-56920be062ba7 1/8

ISO 9000:2005 -

Preventive Action & FMEA 

What is Preventive Action?

We naturally undertake Preventive Action in our private lives but it can be a difficult concept tounderstand at work - probably because we tend to put out fires rather than prevent them.

Let's take the fire-fighter analogy a little further:

● Your house is on fire. You phone Emergency and the Fire Service duly arrive and put out thefire. This is Control of Non-conformance (ISO 9001 Para 8.3).

● Subsequently, you ban smoking, install smoke detectors and fire extinguishers so that minor

fires can be avoided or at least contained. This is Corrective Action (ISO 9001 Para 8.5.2).

● Fortunately, you had the foresight to buy adequate insurance to cover any losses. This isPreventive Action (ISO 9001 Para 8.5.3).

ISO 9000:2000 Para 3.6.4 defines Preventive Action as “action to eliminate the cause of apotential  nonconformity or other undesirable potential situation”.

Don't be thrown by the word 'potential'. Physicists tell us that we live in a quantum universe,every atom is constantly in flux: absolutely anything is possible.

However, because something is possible it does not mean that it is likely. You can only addressthe problems (and potential problems) you know about and try to detect the ones you don't.

What is FMEA? 

FMEA (failure mode and effects analysis) is a team-based activity to assess actual andpotential problems, assign a risk factor and decide a course of action. This method is used inmany industries such as automotive, medical device manufacturing, aerospace, and chemicalprocessing.

FMEA is not  a specific ISO 9001 requirement, however this approach satisfies ISO 9001 Para8.5.3 Preventive Action.

Overview  

Every product or process is subject to different problems or "failure modes" and these potentialfailures all have consequences or "effects". A failure mode and effects analysis (FMEA) is wayto:

•  Identify the potential failures and the associated relative risks in a product or process•  Prioritise action plans to reduce those potential failures with the highest relative risk, and•  Track and evaluate the results of those actions.

The process for conducting an FMEA is straightforward:

7/18/2019 Prevention Fmea

http://slidepdf.com/reader/full/prevention-fmea-56920be062ba7 2/8

First, describe the product/process and its function/purpose

Then identify:

Failures - The manner in which a part, assembly, or system could potentially fail tomeet its requirements or fail to function. It is also what you may reject the item for.

Effects - The potential non-conformance stated in the terms of the process orproduct performance.

Causes - The potential reasons behind a failure mode, usually stated as anindication of a specific design or process weakness.

Severity -  An intuitive assessment of the seriousness of the effect  of the potentialfailure as viewed from the perspective of the customer, your quality system orgovernment regulation.

ISO 9001 Procedural Requirements

ISO 9001:2000 Para 8.5.3 requires a documented procedure for preventive action, it mustdefine:

a) How you identify potential problems, and their causes.

For example:

•  Trend analysis for process and product characteristics (see ISO 9001:2000 Para 8.4data analysis). A worsening trend often prompts preventive action

•  Other early warnings of approaching "out-of-control" conditions.•  Monitoring of customer satisfaction, both formally or informally•  Failure mode and effect analysis for processes and products (this technique is

commonly used by the automotive industry.•  Evaluating problems that have occurred in similar circumstances, but in other products,

processes, or other parts of the business, or other organisations - see your trade pressfor details.

•  Planning for both predictable situations (e.g. personnel changes – see also ISO 9001Para 5.4.2) and for unpredictable situations (e.g. naturally disasters, terrorist threats,etc.)

•  ISO 9004:2000 Para. 8.5.3 Loss Prevention suggests other examples.

b) How you evaluate the need for preventive action.

TOP TIP Para 8.5.3 says that preventive actions must in proportion with the effect of the failure.

Methods used in the evaluation could include:

•  Some form of risk analysis•  FMEA

NOTE: these methods are not  requirements of ISO 9001

c) How you decide what action is required, and how it is implemented.

 An auditor will require evidence that:

•  you have analysed the causes of potential problems (use of cause and effect diagrams

7/18/2019 Prevention Fmea

http://slidepdf.com/reader/full/prevention-fmea-56920be062ba7 3/8

and other quality tools may be appropriate for this). If you want to know more aboutthese tools, follow this link to the UK's National Health Service quality improvement site

•  the necessary actions have been taken, and in a timely manner•  personnel responsibilities for the above stages are clearly defined.

d) Record the results o f the actions taken

•

  What records are kept?•   Are they a true reflection of the results?•  Does their control satisfy ISO 9001 Para 4.2.4?

e) You must review the preventive actions taken

•  Were the actions effective?•  Should we continue with the current preventive actions?•  Have circumstances changed?•  Is it necessary to plan new actions?

FMEA Method 

Who should do it ?  

FMEAs are typically conducted by small team of people, ideally each whom with a slightlydifferent view of the product or process under consideration.

The variety of perspectives that a team can bring to an FMEA is what makes them sopowerful .

 An individual will not be able to develop as comprehensive and valuable FMEA as a team canproduce. One-man FMEAs are typically done to satisfy customer requirements, and generally

contribute nothing to the business.

While the FMEA process is relatively straightforward it is essential that the target product orprocess is well-defined so that the team doesn't go off at a tangent.

Step-by-step  

These steps can be worked through using Post-It notes, a whiteboard or a spreadsheet so youmay add, subtract and modify ideas as you go along.

1 Describe the product 's funct ion or the process's purpose

This helps simplify the process of analysis by identifying the product/process uses that fallwithin the intended function and which fall outside.

It is important to consider both intentional   and   unintentional uses of product, as failure mayend in litigation, which is costly and time consuming

2 Develop a diagram/process map of the product/process  

This should show the major components or process steps as blocks connected together bylines that indicate how the components or steps are related. The diagram shows the logicalrelationships of components and establishes a structure around which the FMEA can bedeveloped.

7/18/2019 Prevention Fmea

http://slidepdf.com/reader/full/prevention-fmea-56920be062ba7 4/8

3 What are the potential failures?  

This relates to ISO 9001 Para. 8.5.3 a).

 A failure mode is defined as the manner in which a component, subsystem, system, process,etc. could potentially fail. Examples of potential failures include:

•  Nuclear reactor melt-down•  Electrical short•  Delays•  Deformation•  Wrong billing address

Remember, a failure in one component can cause a failure in another component.

4 What is the effects of those failures?  

This relates to ISO 9001 Para. 8.5.3 b).

For each failure identified, try to estimate what the ultimate effect will be.

 A failure effect is defined as the result of a failure mode on the function of the product/processas perceived by the customer. They should be described in terms of what the customer mightsee or experience should the identified failure mode occur. Keep in mind the internal as well asthe external customer. Examples of failure effects include:

•  Death or injury•  Malfunction of the product or process•  Improper appearance of the product or process•  Reduced performance

•  Minor cosmetic problem

5 What is the severity of the effect?  

This also relates to ISO 9001 Para. 8.5.3 a).

 A commonly used scale: 1 represents low effect; 10 indicates very severe with failureaffecting system operation and safety without warning.

The intention is to help decide whether a failure would be a minor nuisance or a catastrophicoccurrence to the customer.

6 What causes each failure?

This relates to ISO 9001 Para. 8.5.3 a, too).

 A failure cause is defined as a weakness that may result in a failure.

The potential causes for each failure should be identified and documented. The causes (not thesymptoms) should be listed. Examples of potential causes include:

•  Corrosion•  Contamination•  Improper alignment•  Excessive delays

7/18/2019 Prevention Fmea

http://slidepdf.com/reader/full/prevention-fmea-56920be062ba7 5/8

•  Excessive voltage 

7 How likely is it to occur?  

This relates to ISO 9001 Para. 8.5.3 b). A numerical estimate indicates the probability of the cause occurring.

 A commonly used scale: 1 represents not likely, 10 indicates inevitable

8 What contro ls do we currently have in place? 

This also relates to ISO 9001 Para. 8.5.3 b).

Current controls are the mechanisms that prevent the cause of the failure mode from occurringor which detect the failure before it reaches the Customer.

Decide what testing, analysis, monitoring, and other techniques that can or have been used onthe same or similar products/processes to detect failures.

Each of these controls should be assessed to determine how well it is expected to identify or detect failure modes. After a new product or process has been in use previously undetected or unidentified failure modes may appear.

The FMEA should then be updated and plans made to address those failures to eliminate themfrom the product/process

9 What is the likelihood of detecting the problem?  

This relates to ISO 9001 Para. 8.5.3 b).

Detection is an assessment of the likelihood that the current controls will either•  detect the cause of the failure•  or the failure itself

thus preventing it from reaching the Customer. Based on the current controls, consider thelikelihood of Detection.

 A commonly used scale: 1 indicates that detection is very likely; 10 to indicates that theproblem will almost never be detected.

10 Calculate the Risk Priori ty Numbers (RPN) 

This is the output of ISO 9001 Para. 8.5.3 b).

The Risk Priority Number is a mathematical product of the numerical Severity, Probability, andDetection ratings:

RPN = (Severity) x (Probability) x (Detection)

The RPN is used to prioritise items than require additional action. 

11 Address the biggest issues first  

This relates to ISO 9001 Para 8.5.3 c).

 Address potential failures that have a high RPN. Typically, the top 30% are targeted.

 Actions could include:

7/18/2019 Prevention Fmea

http://slidepdf.com/reader/full/prevention-fmea-56920be062ba7 6/8

•  inspection or testing procedures•  selecting different components, materials or suppliers•  limiting environmental stresses or operating range•  redesign•  preventive maintenance•  back-up systems

12 Who is going to complete the action and when will be done?  

This also relates to ISO 9001 Para 8.5.3 c & d).

 Assign Responsibility and a Target Completion Date for these actions.

This makes responsibility clear-cut and helps tracking

13 Follow-up  

This relates to ISO 9001 Para 8.5.3 d & e).

 After these actions have been taken, re-assess the severity, probability and detection and

review the revised RPN's. Are any further actions required?

14 Update the FMEA  

This relates to ISO 9001 Para 8.5.3 d & e).•  If the design or process changes•  or the assessment changes•  or new information becomes known

FMEA Example Worksheet  

Product/Process

Potentialfailure

Potentialeffect(s) Severity

Potentialcause(s) Occurrence

Currentcontrols Detection RPN

Recommendedaction(s)

Responsibility

& completiondate

7/18/2019 Prevention Fmea

http://slidepdf.com/reader/full/prevention-fmea-56920be062ba7 7/8

The main reasons FMEAs fail  

  Only one person is assigned to do the FMEA.  Not customising the three rating scales with company specific examples so that they

are meaningful to your company.   A design or process expert is either not included on the FMEA team or is allowed to

dominate the team.  Team members have not been properly trained in the use of FMEAs and become

frustrated with the process.  The team gets bogged down with minute details and losing sight of the overall

objective.  Rushing through the generation of potential failure modes, overlooking significant

but obscure failure modes.  Listing practically the same effect for every failure mode and not being specific (for 

example "customer will be unhappy").  Stopping once the RPNs are calculated and not acting on the highest risk failures.  Not re-evaluating the RPNs once improvements have been made.

Final Thoughts 

There is often debate about where corrective action ends, and where preventive action begins.

For instance, if a problem is detected in one process, are the actions taken to avoid possibleproblems in other processes truly  preventive actions?

Or are they simply part of the corrective actions taken to fix the initial problem?

Don't be “side-tracked” by such arguments - life is too short. Instead, concentrate on whether

the actions were effective.

Try to regard Preventive Action as a useful tool to help assess business risks - not just anexercise the keep the auditor happy.

Follow this link to the  ISO 9001 Audit Practices Group  and learn more about modern audittechniques.

If you want to know more about problem solving and investigative tools, the UK's NationalHealth Service Improvement Network has a comprehensive tool box

The leading UK Certification Bodies NQA  and Lloyds Register Quality Assurance both providefree, and useful information on 21st Century quality thinking. 

Best Regards, 

Stephanie Keen 

Stephanie Keen 

Managing PartnerISONavigator Management Systems  

E-mail info@iso9001help.co.uk 

7/18/2019 Prevention Fmea

http://slidepdf.com/reader/full/prevention-fmea-56920be062ba7 8/8

Web http://www.iso9001help.co.uk 

p.s. click here to Order  QM 9001 

p.p.s. e-mail  for our ISO 9000 tips  

Customer satisfaction - how useful was this paper? Please give us some  feedback

 

IMPORTANT NOTICE

If you wish to opt-out and not receive further e-mails please Reply to this message and changesubject line to “Unsubscribe”. This e-mail and any attachments are private and confidential andmay also be subject to legal privilege. If you are not the named recipient, please notify thesender and destroy the e-mail and any attachments. Statements and opinions expressed in this

e-mail may not represent those of the company. Any review, retransmission, dissemination andother use of this information by persons or entities other than the intended recipient isprohibited. This e-mail has been scanned for malicious content but the internet is inherentlyinsecure and ISO Navigator cannot accept any liability for the integrity of this message or itsattachments. Although this e-mail and any attachments will have been checked for virusesbefore transmission, no warranty or guarantee can be given that the e-mail is virus-free. All e-mails sent and received by us are monitored to ensure compliance with the Company'sComputer Policy. While every effort is made to ensure the accuracy of the information provided,you are solely responsible for deciding its relevance and applicability given your uniquebusiness situation. No liability is accepted if you choose to act upon this information. The use ofISO 9004 is strongly recommended