Requirements

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8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

 

Measurement, analysis and improvement forms a fundamental part of the management decision making tool and techniques. If we don’t measure we cannot bench mark where we are, is it getting better or worse. Flowing from the measurement process are our methods of how we analyse the data and then finally apply improvements. It should be seen as a continuous process applying itself on an ongoing basis to every facet of your business. Although this section is titled, Measurement, Analysis & Improvement it does not contain all of the requirements. Most of the other core requirements also detail similar elements. For example: Monitoring & Measuring - Management Review (5.6) - Control of Measurement & Monitoring Devices (7.6) Analysis - Management Review (5.6) - Control of Design & Development Changes (7.3.7)

 

8.1 General

This section requires you to plan your measurement, analysis and improvement activities so not to leave such processes to chance or to the last minute. It applies itself on 2 primary levels:

• product conformity
• system conformity and improvement

At this time also the need and use of statistical techniques should be reviewed and if necessary applied.

 

8.2 Monitoring & Measurement

 

8.2.1 Customer Satisfaction

The first area of monitoring and measurement, and possibly the most important, relates to your customers perception of the product/service that you have provided. Remember in ISO 9001:2000 when the word customer is used, it is referring to your external customer. Key work here is perception of your service/product. So you may have delivered exactly as per your understanding of the requirement, but the customer is still not satisfied! Tough one, but this is the reality of the notion of quality. Customer satisfaction statistics can come from numerous sources (with possibly conflicting results which then need analysis), such as:

• compliments
• complaints
• sales statistics
• surveys
• formal feedback

The results from this section form an input to the Management Review requirements (5.6)

 

8.2.2 Internal audit

Internal audits have to be conducted on your own quality systems to ensure compliance to the ISO 9001 standard. These audits must be planned, systematic, documented and independent to be effective. To achieve this you need to select and train a team of internal auditors (preferably, rather than use external auditors) who need to be:

• independent, eg not auditing the areas in which they work
• competent, eg trained to conduct effective audits
• impartial, eg. have the seniority not to be afraid to tell it as it is
• objective, eg able to provide objective actions based on the findings.

 

8.2.3 Measurement and monitoring of Processes

This is different form measuring the product, which is the output of the process. Here we need to measure the process itself to produce a conforming product / service. Monitoring could comprise of observing the process and applying changes before potential problems occur. Measurements would comprise of testing the process against pre-determined standards.

 

8.2.4 Measurement and Monitoring of Product

These relate to inspection, verification or testing of the product which can be carried out at any convenient stage in the production or delivery process. This may be at final stages of production or during any earlier processes. Records need to be kept of this measuring and monitoring activity to verify results. Furthermore release of a product or service to a customer should not take place until final checks have been made and successful verified.

 

8.3 Control of Non Conforming Product

Non conforming product relates to results of the product inspection against predetermined specifications or requirements. Once identified as such, non- conforming product must be controlled to prevent its inadvertent use. The identified non-conforming product must then be processed to decide its ultimate disposition (eg. rework, scrap or acceptance under concession). As with the inspection activities, records need to be kept of non conforming product processes. Once repaired and reworked, the now conforming product must be re-inspected to conform compliance.

 

8.4 Analysis of Data

This refers to the collection, in the first instance, of all relating data relevant to the quality management system. This could include:

• customer complaints/satisfaction
• product conformance data
• suppler performance information

Once collected it should be then analysed by management to turn the data into information that can then form the basis for factual decision making.

 

8.5 Improvement

 

8.5.1 Continual Improvement

This requirement concerns itself with how you are improving your quality management system on an ongoing basis. The use of continual improvement comes up a number of times in the standard, for example, continually improving:

• effectiveness
• processes
• management commitment
• resources needed
• through the use of quality policy, objectives, ect.

 

8.5.2 Corrective Action

This is the part of the non-conformance cycle that closes the loop, eg, addresses preventing the non-conformance from happening again. This is in contrast to preventive action where that looks at preventing the occurrence of non-conformity prior to it happening. As with previous section, corrective actions must be documented, and once applied corrective action should be verified that it has been effective.

 

8.5.3 Preventive Action

This is the process of reviewing potential problems and where necessary instigating actions before they result in non-conformances. As with corrective actions, document them and check results of actions for their effectiveness.