Non-Conformance

Non-conformance occurs when you are unable to achieve the desired outcome. That means, something gets in the way of you achieving a stated goal. Examples might include many things. A machine might not be working properly. Perhaps, product tolerances have failed to meet the standard required. Alternatively, suppliers may not be performing. Possibly, a procedure or process is at fault. Maybe, your staff are not able to complete the work properly. Whatever the problem, you need rectify it, or it will get in the way of future success.

Business owners often say, “But, my business is profitable”. However, there is always room for improvement. Higher profits should follow from improvements in the organisation’s processes, products and services. Conversely, financial and good will losses quickly follow if your business is doing something wrong.  So, how do we search out those improvements?

The first thing is to develop a mind-set and look for methods to  put in place a continual improvement process. Start with the biggest problems first. Those usually directly effect customers. Look, also, for issues that make it difficult for the staff to focus or work to a high standard.

Investigating non-conformance

Managing a non-conformance is an important method to improve any business.  The first step, is to find a problem. By identifying and fixing problems, you will reach your goals. With each improvement, you move closer to your desired outcome. So, investigating non-conformance is an essential step toward successful improvement.

How do you find non-conformances? No suprises here. Your management system will lead the way. Non-conformance can surface through…

• Staff feedback.
• Poor staff motivation.
• Failure to reach a specification.
• Poor staff training causing inconsistent product or service.
• Product or service failure.
• A process, tool or equipment failure.
• Financial analysis revealing operational problems.
• Customer complaints.
• A management system Audit.
• Routine inspections.

Having identified the problem, document it. Get examples and factual evidence of the issue. Facts will show whether the problem is a one-off, or a trend. Once you establish that, you can then determine the level of resources needed to rectify the problem.

Go Head-to-Head with problems

It is important to tackle non-conformance head on. Often, immediate action may help, but provide only a temporary fix. A thorough investigation will isolate the exact problem you have. Search for two things. First, find out the real or underlying reason for the non-conformance. Second, you need to know the impact on your customer. Any effect on your customer will also impact other aspects of your business or work processes.

Focus on how to solve your problem within your management system. Are the procedures wrong? Is the process undocumented or badly written? Are the staff properly trained? Are the machine processes meeting the customer specification? These sorts of questions should lead you to better understand the problem. Also, it will help you realise how to correct it. Ideally, you should be looking for a Quality System issue. That will lead you back to a practical issue.

Impact

The impact that non-conformance has on your goal is also important. If fifty percent of your product is unfit for the customer, you have a huge problem. On the other hand, if you have one failure for every million units at only pence to make, the impact is much smaller. The organisation’s management must decide whether an impact is acceptable or not. If the impact is tiny, the cost of perfect production might be prohibitive. In that case, managers might decide to accept the small loss of such a low failure rate. However, you cannot sustain losses at, say, a fifty percent fail rate. Act immediately.

Any non-conformance with a significant impact needs sorting out, and soon. Full understanding of the problem from your investigation should help you to identify corrective actions. These will allow you to address the non-conformance. Consequently, you should also be able to identify the resources (staff training, finance, management system changes etc.) to put in place. Now you can actually rectify the problem by applying the appropriate corrective action. Your aim is to ensure that the non-conformance will not re-appear.

Formal recognition of non-conformance

There are four levels of non-conformance. An external auditor assessing your system will normally apply these levels…

1. Major Non-Conformance. Not fulfilling one of the clauses of the Management Standard affects the ability to achieve the intended results. It can be prompted by a single issue or multiple minor issues that could demonstrate a failure of your system overall.
2. Minor Non-Conformance. This represents a problem. However, it is not affecting the capability to achieve the intended result as required by the Standard.
3. Observation. A weakness or potential deficiency, which could lead to a non-conformity.
4. Opportunity for Improvement. Normally, this is a suggestion related to industrial ‘Best Practice’, quality upgrade or improved work standards an so on.

Corrective action – a positive improvement

After an investigation, you can often implement a quick corrective action to secure the problem. This leaves time and opportunity to find a fully effective solution. Call in the management team. The investigation should inform them of the alternative options. They can allocate the time and resources to complete the corrective action.

Corrective actions must bring significantly reduced risk of repeat problems. You do not have a solution if it creates other issues or allows the original problem to return. Look for opportunities to improve your systems, simplify, tighten your controls and make positive improvements. These will help your organisation move forward in the spirit of continuous improvement. After all, it is your whole business you are improving – not just one process. The effect of improvement is cumulative.

Remember, corrective actions should not lead to punitive actions. Your staff must have faith that system improvements will bring a better outcome for all. Otherwise, your staff will lose faith in the management system. Instead, take a formal and factual route through a non-conformance investigations. Consequently, your actions should show that everyone wins. That way, the staff feel supported and the business is improved.

Moving forward, getting better and better

Your organisation should address the big problems from the start. Get those out of the way. Then, you can move onto the less significant problems. Niggling problems that persist over time drain the energy of everyone involved. Little problems seem to have a small impact, so, nobody takes the time to resolve them. Unfortunately, lots of small problems add up to a big financial waste, or waste of time, or become a hazard. Often, little problems cumulatively sap the resources of the organisation.

Your management system can help you reduce these niggles. Firstly, get the main non-conformance problems out of the way. Then you will find yourself doing less “fire-fighting”. That leaves more time for managing your business. Thus, your management system has created an opportunity for you to deal with the lower-level non-conformances. Soon you will be able to streamline your business all the way through.

How can we help?

CHARTER4 has many years of experience helping organisations implement ISO Management Systems. We have worked with a whole range of management systems. ISO 9001, often forms the core part of these important Management Systems. We have helped many businesses to gain ISO 9001 Certification and then to go on and successfully implement further ISO Standards.

Our focus is a little different from other consultancies in the ISO field. We feel it is important to ensure that businesses gain Certification. However, we also recognise that there is a lot of work and commitment needed to get there. So, we support our clients in ways that help them to get practical returns on their ISO Standards’ investment. We go the extra mile. In fact, our guiding principle is, “Improve your business, rather than just comply”. Perhaps, you would like to see how we can take your business into new realms of success with ISO Standards. Please, click one of the buttons below.