Quality management system development

Why should you have a quality management system?

A quality management system is the first step towards truly understanding your business. A good QMS structures your business approach, embedding continuous improvement as a way of doing business.

The standard starts with asking you hard questions about your business and your customers. The system then takes a look at leadership, defining what the responsibilities of top management are, and what processes they must put in place. Planning comes next, to ensure the business understands what must be managed to succeed. Now the business knows what must be done, the resources must be made available to deliver on the plans. Operational control is required to ensure the products are properly designed, the processes for procurement, manufacture and control are in place and that operators know what to do when there is a problem. The process also has to be measured, this includes auditing and non-conformance management. Finally, the system demands continuous improvement.

As an ISO9001 lead auditor and lean six sigma master black belt I can integrate process improvement using world-class tools into your documented system.

Contact me for a discussion to see how I can help your business.

Don’t just move the average, understand the spread

Picture the scene; someone in your organisation comes up with a cost-saving idea. If we move the process mean to the lower limit, we can save £’000’s and still be in specification. The technical team doesn’t like it, but they can’t come up with a reason other than “it’ll cause problems”, the finance director loves the idea, and the production manager with one eye on costs says, well if we can save money and be in spec, what’s the problem?

Let me help you. 
In this scenario, the technical team may be right. If we assume that your process is in control and produces items with a normal distribution (remember that is the best case scenario!) logic dictates that half of your data is below the average value and half is above. That being the case, what you really want to know is how far from the average the distribution spreads. If the spread is large and you change process to the extreme where the average value sits right on the customer specification limit, half of everything you make will be out of spec. Can you afford a 50% failure rate? What will the impact be on your customers, your reputation, your workload (dealing with complaints). 

To work out how much we can move the process, we must first understand how much it varies, and we use a statistical value called the standard deviation to help us. Standard deviation is the average variation from the mean for a sample data set. To work it out, take 20 samples, measure them all 5 times then use a spreadsheet to work out the mean and standard deviation. If that is too much take 10 samples and measure 3 times. Keep in mind that the smaller sample size will give a larger standard deviation. Now take the mean and add 3 x standard deviation. This is the upper limit of your process spread. Subtract 3 x the standard deviation from the process mean to find the lower limit of your process spread. The difference between these two numbers is the spread of your process and will contain 99.7% of the results measured from the process output IF the process is in control and nothing changes.

If moving the mean takes the 3 standard deviation limits of your process outside of the specification, you will get complaints. It could be that the limits are already outside of the specification, in which case moving the average will make a bad situation worse.

It is possible to calculate the proportion of failures likely from a change of average, this done using z-score calculation. I’m not aiming to teach maths, so the important message is that the failure rate can be calculated.

This is the tip of the iceberg with understanding your process. If you don’t know that your process is stable and in control, the spread won’t help you because the process can jump erratically. To improve your process

1. Gain control, make sure the process is stable.

2. Eliminate errors and waste

3. Reduce variation

4. Monitor the process to make sure it stays that way.

The most significant and profitable gains are often from process stability, not from cost-cutting. All cost-cutting does is reduce the pain, think of cost-cutting as a painkiller when you have an infection. It makes it hurt less, but doesn’t stop the infection. You need to stop the infection to feel better.

Now do you want to hurt less or do you want to get better?

Why does variation and the type of variation matter?

Everything varies. We know it happens, and if you can’t see it, the variation may not be that significant to your process. However, it may be that your measurement systems are incapable of detecting significant variation that is important to your process, more about that in another post. Variation leads to production problems, waste and ultimately quality and delivery problems. Control the variation, you control the waste and costs. If waste and costs are a problem in your business, you may be interested in reading on.

There are two types of variation, common cause and special cause. Common cause variation is natural, characteristic of the process and most importantly, predictable. Special cause variation is caused by external factors acting on the process and is not predictable. This is an important distinction because the methodologies for investigating special and common cause variation are different, and if you investigate the wrong sort of variation it can waste a huge amount of time and cause frustration.

Take the process shown above. Just creating a graph of the data isn’t really useful, since it is unclear what should be investigated, or how to proceed. Typically a manager will look at a trend line to see if the process data is trending up or down. If the process is in control and (often) a manager observes an undesirable deviation from target, it is common to ask for that to be investigated. If the investigation focuses on special cause variation which is likely, since the investigator is likely to assume something is “wrong” therefore there must be a root cause. In businesses that do not use process control charts, there is no objective assessment of process performance before launching into seeking the root cause. The problem this creates is that there may not be a root cause. If common cause variation is at work, it is a fruitless exercise.

Where a root cause analysis finds nothing, managers can assume that the investigation is flawed and demand more work to identify the root cause. At this point willing workers are perplexed, nothing they look at can explain what they have seen. Eventually, the pressure leads to the willing worker picking the most likely “cause” and ascribing the failure to this cause. Success! The manager is happy and “corrective action” is taken. The problem is that system tampering will increase the variability in the system, making failures more likely.

The danger is then clear, if we investigate common cause variation using special cause techniques, we can increase variation through system tampering.

What then of the reverse, chasing common cause corrections for special cause variation. The basic performance of the process is unlikely to change, and every time there is a perceived “breakthrough” in performance, as soon as the special cause happens again the process exhibits more variation. The process does not see an increase in variation however, neither is there any improvement in the variation.

The only way to determine if the process is in control, or if a significant process change has occurred is to look at the data in a control chart. Using a control chart we can see which variation should be investigated as a special cause, and where we should seek variation reduction. In this example, the only result that should be investigated is result 8. This is a special cause and will have a specific reason. Eliminate the root cause of that and the process is in normal control. Everything else appears to be in control. Analysing the process data in this way leads to a focused investigation. If after removal of the special cause the process limits are inconsistent with the customer specification, variation reduction efforts should focus on common cause variation.


What does quality mean and why should everyone be involved?

Everyone knows what quality is don’t they?

Or do we? I suspect there are a few words missing from that statement.

Everyone knows what quality means to them.

So why do we run into quality issues in business? In my experience it is usually because the person making promises (specifications) doesn’t have to deliver against them (product or service provision).  The meaning of quality is variable, depending on the purpose of the product or service, and the customers need. For example, if I want a quality car, my criteria are very different if I am a lottery winner, or earning minimum wage.

It goes hand in hand with the idea of “fit for purpose”. Often when judging if something is fit for purpose we are making a commercial judgement of risk to our business of receiving a complaint, when a product is outside of the agreed specification. If his commercial question becomes a technical question the standards drift. By the time our customer complains we are a long way from what was agreed and often don’t understand how we got here, and more importantly how to fix it.  I believe the question we should really be asking is this

“If I was the customer receiving this product or service, with the customers standards, would I accept it?” . If the answer is yes, check you are right. Respect your customer enough to ask them.

We must always remember that decisions about fitness for purpose and quality will always belong to the customer.

It is vital to ensure everyone is involved. If our employees understand why the specification is important to our customer, and the impact of being out of specification, they are more likely to ensure the specifications are met.


Simple. Tell me I forget, show me I remember, involve me I understand. It is only through open communication and transparent understanding that we can engage all of employees in delivering excellence for the customer.

Let’s engage all of our employees in delivering the customer’s vision of excellence within the cost constraints agreed.


Are you ready for ISO9001:2015?

By now everyone who is certified to ISO9001:2008 knows they have to transition to ISO9001:2015. But it’s all OK, it’s the quality manager who has to make it happen right? And we have time too, there is a long time to changeover.

Actually no, there isn’t that much time and the quality manager can’t do it alone. ISO9001:2008 will cease to be a viable standard in September 2018, that is less than two years. If your company has a lot of cultural adjustment that is not much time at all.

The new standard places much greater emphasis on top management involvement, placing greater responsibility for the quality management system on top management. this means that although top management can delegate authority for certain tasks, responsibility for making those things happen can’t be delegated.

One example is responsibility for the QMS, the standard says top management is responsible for demonstrating leadership and commitment by ensuring the integration of the quality management system requirements into the business processes. This means that authority for ensuring that the business processes meet the needs of the QMS rest with the individual process owners, not simply the quality manager. If your production manager isn’t committed to the QMS and has a habit of regarding the QMS as the quality managers job there will be a problem during audit. Also, the previous quick tidy up just before an audit will be unacceptable. There must be a consistent approach to the QMS evidenced all year round. The requirement is for integration of QMS requirements into the business processes – if the business processes operate every day, but the QMS activity all happens in the month prior to an audit, there is a clear dysfunction.

The new standard also does not require any mandatory procedures. I hear you cheering, but before you make a bonfire out of your manuals there is a catch (isn’t there always!). If there is no documentation the auditor has to interview top management and the staff operating the process to check that there is a common view of what is to be done, roles and responsibilities and a consistent methodology to carry out the process. Interviews take time and it has been reported that some certification bodies are adding between half a day and a day to the audit requirements where documentation is minimal. Consider as well how easy it will be to ensure that all of your staff from managers to shopfloor not only operate the process in the same way, but describe it similarly enough to be recognisable as the same process.

Bear in mind these are only two aspects of twenty-two specific responsibilities placed on top management in clause 5 – Leadership.

Another new clause is 7.1.6 Organisational Knowledge. This mandates that an organisation will determine the knowledge necessary for operation of its processes not only now, but also in the future. This includes identifying what new knowledge and skills will be required to address the changing needs and trends of its business environment. Further changes addressing the need to consider products and services and ensure that key performance indicators are identified and where deemed appropriate, monitored and measured mean that this version of the standard really does have to integrate into the business operation.

Another addition is included in the way businesses think about their processes. In addition to arranging the processes in order and linking them logically, it is also necessary to identify the process inputs and outputs. In order to do this the process owners have to understand how the processes link together. If it isn’t done, don’t blame the quality manager; the responsibility for making it happens lies with top management, which means that the process owners have to be involved.

This is not a thorough review of the implications of ISO9001:2015, it is only intended to give a flavour of the challenges ahead. If this sounds like a task you would appreciate some help with, contact me at Tamarind Tree Consulting – I can help. Head over to my website where you can see my experience and contact me through the website, or message me on LinkedIn to discuss how I can help you meet the September 2018 deadline for transition.

Baldwin Francis

Case Study for ISO9001:2015 Transition

Baldwin and Francis manufacture flameproof and intrinsically safe electrical switchgear for hazardous environments. Their primary markets are oil and gas, marine, rail and industrial sectors

The existing system meets the needs of ISO9001:2008, however with ISO9001:2008 expiring in 2018 B&F must plan a transition to ISO9001:2015. As a result, Baldwin and Francis Ltd  asked Tamarind Tree Consulting to modify their quality management system in preparation for the ISO9001:2015 transition.

The transition task is more complex for Baldwin and Francis Ltd since they have to also consider the additional requirements of ISO/IEC80079-34:2011 It was essential that the consultant used could ensure that the requirements of both standards were integrated. A vital aspect of the business is disciplined application of both standards to ensure that the equipment provided ensures the safety of electrical distribution in explosive atmospheres.

With only six weeks to the next transition audit it was vital to ensure that any alterations were practical and closely managed. It was also essential to ensure that all progress was sustainable to ensure that it provided a platform for future system development.

Installation support

Tamarind tree conducted a gap analysis of the system to identify both the required changes and the necessary care points. This was designed to ensure that the changes would not compromise system integrity or product performance.

Working in collaboration with the team at Baldwin and Francis Ltd, the first step was to train auditors to assess the system against both ISO9001:2015 and ISO/IEC80079-34. Auditors were selected from a range of functions across the entire business. The document control system was modified to include risk assessment of processes and a systematic review of the business processes was initiated.

The system modifications identified by Tamarind Tree Consulting assisted in a positive external audit result. Ongoing certification was maintained and the external auditor confirmed that the system complied with the needs of both ISO9001:2015 and ISO/IEC80079-34:2011.

Feedback from Baldwin and Francis was very positive, with particular recognition of the timely, expert and engaging  service they were provided

Stephen Clarke, CEO and Managing Director of Baldwin and Francis stated,

“ This has been a very successful project. Tamarind Tree Consulting led my team throughout the task in a practical, knowledgeable way. Tim Akerman quickly engaged with all employees, fully understood our needs and delivered the actions required to meet the audit deadline as well as re-aligning our plans for the transition to the new standards. All on time and to the agreed costs. I am sure that we will be using their services again”