The Q&A
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As an experienced auditor, I agree entirely that systems should be effective rather than just followed. But what does ‘effective’ mean in ISO 9001? Is it enough simply to check that there are some key performance indicators (KPIs)?
At least we are all agreed within the certification business that unless a management system is effective it may not be worth doing. An ineffective system can create unnecessary conflict within the business, drain resources and lead to the company taking its eye off the ball.
Effectiveness is a balance between the various cost elements associated with getting it right. Traditional quality control primarily directs its efforts into inspection by finding and removing errors already created and paid for. Management systems lean more towards the principle of the identification of problems and setting management programmes to avoid or at least reduce the impact of their occurrence. Last, there is the apparently cheap option of waiting until something goes wrong and then bearing the cost of recovery. This last option is really just gambling with the business, its staff and its customers.
It has to be accepted that there is no single solution to the question of effectiveness as reliance on total inspection can be very costly as can clearing up the mess after the event. An effective management system is actually a blend of principles taking the most effective and cost efficient means of achieving the desired result.
The main influence affecting the effectiveness is the level of understanding of the senior management of a business as to how and where a management system is best deployed. This starts with the scope and documentation, which will govern everything that happens subsequently. If you can get this right the operational effectiveness and associated costs will be beneficial. The final measure of the effectiveness of all these activities is - does it produce results. The use of KPIs is one of the methods a company can use to measure or monitor effectiveness but they are only as good as the methodology used to plan and set the parameters and control limits.
By BM TRADA Certification Ltd
Bob Foster is a technical manager working in BM TRADA's accreditation department. For more information visit www.bmtrada.com
ISO 9000:2005 defines effectiveness as: ‘The extent to which planned activities are realized and planned results achieved’. So what does this mean? The key to the above definition lies in the word ‘planned’. Without adequate planning of what is to be done and what is to be achieved from these activities, it would be impossible to determine any form of effectiveness.
So what is effectiveness? Clause 8.1c of ISO 9001 deals with the effectiveness of the quality management system. Well, the above definition gives an indication of how this should be used within an organization. Effectiveness should be analyzed together with efficiency. An organization can be highly efficient but if that efficiency means that the client’s requirements or objectives are not met, then they haven’t been very effective. Similarly, an organization can be highly effective but if they are very inefficient in providing what the client wants, then this could be very costly to the organization.
One area where effectiveness can be measured are the costs incurred by a business in order to run their systems. What value is gained from their systems? Why do they have systems?
The answer will likely be to control the organization, which can have an impact on how effective the organization is. Organizations need to take a long hard look at their processes to see if firstly the processes themselves are effective in delivering what the client requires; and secondly they deliver the products and services from a strategic view point on the most effective way for the client and the organization.
Some KPIs that might be measurable are:
- customer satisfaction
- cost of delivering the product or service
- staff attrition and attendance
By BSI
John Hele is a global product manager for BSI. For more information visit www.bsi-global.com
The dictionary defines effectiveness as ’producing results, competent’, which does correlate with the thinking behind its use in ISO 9001. In ISO 9004:2000 an example of effectiveness is given ’as outputs meeting requirements’. So effectiveness is about what is being produced, ie the output from a process, being ’competent’ or achieving the desired result.
In practice what does that mean? The output from a process may be an iced fairy cake with a cherry on top. The company making them may wish to increase their profit margin this year and need to produce each cake for 15p, but for every 100 made, 25 are rejected, as they have the cherry missing, causing the cost of each saleable cake to be 20p. In this case, the process may be ‘compliant’ in terms of following a defined process flow or procedure, but not effective as it does not produce the required result (a 15p cost of production).
Performance indicators can be helpful in determining if a process is effective, but they have to be correctly set and a good assessor will look beyond their mere existence to understand what they should be an indicator of. In the scenario above a KPI could be set for a reject level of 25 per cent, which would be met, but the ultimate aim of the company would never be achieved with reject levels so high.
So KPIs are useful, but more is needed to determine system effectiveness. This is why ISO 9001 requires a policy, objectives, a clear understanding of customer requirements, the sequence and interaction of processes to be defined and controlled, audits to be undertaken, customer feedback solicited etc. as a process can only be deemed effective or not when it is understood in the context of the whole.
LRQA
Don Stanley is LRQA’s UK head of assessment. For more information visit www.lrqa.com
What you say…
To my mind ‘effectiveness’ or rather the ‘degree of effectiveness’ is the extent to which planned activities are realized and planned results achieved. For example, if a company quantified annual target for ‘customer satisfaction’ as 98 per cent against the existing level of 90 per cent, but has achieved only 92 per cent well, its effectiveness in this respect is questionable.
By Charanjit Singh, via IRCA Online Forum
One cannot audit to the ISO 9001 standard without auditing effectiveness, as this is very much a stated part of the standard. Therefore, an auditor making a determination of whether or not a system is effective is not just giving his or her personal opinion.
If I am on a certification body audit and I pick up several non-conformities that were recently audited by the organization's internal audit programme, and overlooked, then is that internal audit programme effective? I think not.
If most people in an organization cannot tell me their quality policy, quality goals and objectives, or how they are doing in achieving those objectives, is the communication of the organization effective? Again, unlikely.
While there is some measure that is subjective in determining effectiveness, I still advise my audit team members not to leave their common sense at the door.
