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Lead Auditor Certification
I have just found out that, as expected, I passed the Lead Auditor training course with MfQ. The training should not be underestimated, the case studies and challenges in the course require careful thought from experienced heads as well as newcomers. That said, I have enough experience it would have been embarrassing had I not passed.
It does raise an interesting point, although my training is certified, and the training is accredited by IRCA, I am not a certified IRCA lead auditor. There is a separate, detailed programme of audit evidence to provide before I can be certified by IRCA as a lead auditor. I am certified as having passed a training course that complies with the requirements of IRCA as lead auditor training.
The next step on this journey is to look for opportunities to practice audit skills with the aim of achieving IRCA lead auditor status. This is the continuous improvement life. Learning is not an activity that you do for a time then stop, learning is a lifelong obsession when you are totally committed to continuous improvement.
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.
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”
Risk in the quality process
Under the revised ISO quality systems standard ISO9001:2015 there is a requirement for risk assessment, but what does that really mean?
It is relatively easy to understand risk in the context of safety or environmental contamination, but how does risk apply to quality? The best way to start looking at this is to think about what a complaint is; complaints happen when the business has failed to deliver the customer’s expectations against an order. A specification was agreed, the customer had a clear vision of the benefit they would experience from purchasing your product, but it failed to deliver.
Sometimes the product attracts complaints even though it meets the specification. Why?
Part of the revised standard requires businesses to understand the context of their business, in other words do you understand your business strategy and the market segments you are targeting? Also who will buy from you and who are your competitors?
From start to finish of delivering a product or service there are risks. Did we understand what the customer asked for, does the customer understand what they need, did we produce what we expected to produce, was it delivered on time? There is a tendency to assume that the customer knows what they want , understands how my product will achieve their aims and knows how to use my product. Sometimes this is true, but often there are assumptions and misunderstandings in the buying process that make this a false view.
There are several points at which the risk of providing the wrong product or service can be controlled. The first is ensuring we understand what the customer wants, which involves not only understanding the stated requirements of the customer, but also the unstated requirements such as obvious or industry standards in the customers business that they would just expect us to know. One example would be renting a room in a hotel – do you need to specify the the room has a bed in it? If our standard products don’t satisfy the customer needs or their stated requirements, what else do they need that we don’t know about. the risk of failing to address this is the customer choosing another supplier.
These considerations were implicit in ISO9001:2008, but have been made explicit in ISO9001:2015. There are many ways to manage risk, but we can only manage risks when we assess what the risks are.
One of the most significant changes in ISO9001:2015 is bringing the requirement to understand the legislation that is relevant to your business. This was always a requireemtn, but with the harmonisation of standard structure from Annex SL, the legislative requirement has been made more obvious.
Another area that has been strengthened with more rigorous risk analysis is handling of non-conformance. Whilst consideration of the risks associated with releasing the product have always been considered, an FMEA approach requires us to consider both performance and commercial risks, which may not have been clear before. What are the potential costs of failure compared to the cost of rejecting or scrapping the product? This is not a licence to release anything, far from it. An effective FMEA on a non-conforming product should involve all stakeholders, which must include the customer. Can we afford to involve the customer in a decision about defective stock? Surely it is healthier for the supply chain if we do, it also gives the customer a chance to consider the real impact of a defect, not only on their process, but also on their total supply chain costs.
Rejecting something that is out of specification seems an easy choice, but it creates costs which will come back later in the form of price increases.
Auditing is an area where risk has become an explicit consideration. It is no longer acceptable to simply audit on the basis of auditing all procedures every year, now we must consider the risk to the business of a failure in a particular area. When you consider the risk it becomes obvious that just auditing every process every year is not the right thing to do. For example if there is a manufacturing process that is absolutely critical to customer quality, would it make sense to audit that process at the same frequency as a process that causes a minor inconvenience if there is a defect?
In conclusion, applying risk analysis techniques as part of the QMS encourages the business to consider its strategy, objective and environment in a structured and rational way. Using risk analysis in this way helps a business integrate its quality functions into the daily business operations and makes it almost impossible for a business to run a QMS in parallel to standard business operations. Integration at this level results in safer products, more accountability and better customer satisfaction.
Lean and Six Sigma; Is it a choice or collaboration?
I regularly see posts and discussion points asking what are the differences between Lean and Six Sigma, should Lean or Six Sigma be used first, and if Lean is better than Six Sigma. I find it really puzzling that people involved in continuous improvement still have this debate, especially since the two techniques are not alternative approaches, but are complementary techniques.
Let’s take a quick look at these three questions
- What are the differences between Lean and Six Sigma?
Lean is the practical application of the Toyota Production System. Lean started out as a simple way to ensure that business were focused on the things that customers value and ensuring the activities in the business are as efficient as possible at delivering customer value. Lean focuses on process velocity, reducing waste in all forms and eliminating non value added activities. There is a bias to immediate action Lean, to ensure that waste is removed in the shortest possible time.
Six Sigma was developed by Motorola to enable effective competition against high quality imports from Japan. Six Sigma is a highly structured process aimed at understanding and reducing variation to ensure that the process always delivers the product or service required by the customer. Six Sigma requires statistical evidence and proof of performance, with a mantra of show me the evidence, the ultimate aim of which is to ensure the product delivered is absolutely consistent and within specification. Six Sigma has a bias to understanding the customer and only acting on statistically valid evidence.The aim of both Lean and Six Sigma is to reduce waste, particularly defects, improve process performance and thereby increase customer satisfaction. Lean aims to achieve this by identifying and removing waste and non-value added activities. Six Sigma aims to achieve this by ensuring the customer needs are fully understood and the process is capable of delivering the required product consistently.
- Which Should be used first, Lean or Six Sigma
My perception is that if a practitioner is more comfortable with Lean they will use the lean tools first and if they are more comfortable with Six Sigma they will apply Six Sigma first. Let’s phrase that question differently and see if it still makes sense.
Do you want to reduce waste, defects, and lead time for your process through Lean, or do you want to reduce waste, defects and lead time for your process through Six Sigma? I believe almost every production manager and senior executive would ask one more question; why do I have to choose?
Lean and Six Sigma processes are valuable and there is a strong crossover in the skills. For example if final checking of a process is unnecessarily complicated and yielding too many defects, would you want to be certain that the test method was correctly identifying defects? Of course, therefore we should use Six Sigma first right, because that is where we find Gauge reproducibility and repeatability tools? However, would you want to eat until that was done before simplifying the process? If we give in to the tyranny of “or” we have to choose. What if we choose and instead, and use different groups in the team for both exercises. We need to make sure they communicate effectively, but if the tasks are perceived as of equal importance and we promote a collaborative approach, we can get both done in parallel. That way we eliminate the non-value added steps and ensure that we can separate good parts from bad parts.
If we start with Lean we end up with a simple process (good) without knowing if our output performance is due to the test method, operator or parts (bad). If we start with Six Sigma, we know where the variation finished part performance comes from (good), but the process is still very complicated and we still can’t clearly see what needs to change (bad). If we apply both techniques in parallel we get a simplified process (good) with clarity of process performance (good). Applying both in parallel gives the best results. - Is Lean better than Six Sigma?
Is your car engine more important than the steering? Neither works well without the other, having a car that can go fast, but is hard to direct is not going to work, equally having an excellent capability to direct the car, but nothing to make it move is also going to fail.
Lean and Six Sigma are complementary and whilst each is an excellent tool in it’s own right, when used together these two tools yield results far in excess of what each can give alone. Neither is better than the other, they are different and they are complimentary. Lean or six sigma is not a binary choice, it is a comprehensive toolkit for solving problems.
Just as an engineer uses different tools and techniques for different structures, so Lean and Six Sigma should be applied when the tools and techniques are appropriate to the task in hand.
So my final message on this would be don’t worry about whether the improvement process should be lean or six sigma, instead worry about whether the tool selected to improve the process will yield the most effective solution. In other words don’t get trapped by the tyranny of “or” instead be empowered by the freedom of “and”.
Lean out for low hanging fruit?
What is lean?
So many times when people start implementing lean they focus on so called ‘ low hanging fruit’ but is that all there is to it?
The approach of some practitioners would suggest it is, however there is so much more than just taking ‘low hanging fruit’. Also let us not forget that low hanging fruit is often overripe and may not be the best quality!
So where does this focus on ‘low hanging fruit’ come from?
My perception is the reason for such immediate focus on ‘low hanging fruit’ comes from two things. Firstly, there is an unrealistic expectation of the rate of improvement from process improvement activities. Many senior executives seem to have a very short horizon for improvement, and if money is to be spent on process improvement there must be a return within six months, sometimes within three months. This forces a focus on short term improvements, the so called ‘low hanging fruit’. There is nothing wrong with making these improvements, they are free cash, necessary and failing to address them can be damaging to profitability and performance, but this approach should not be confused with a structured lean implementation.
‘Low hanging fruit’ approaches will deliver short term improvement in both process and financial performance, however this will be unsustainable and will not drive the business to be a time based competitor. It is implicit in the description that these rewards are easy to access and obvious things to do, so what is the difference in lean manufacturing? We are making improvements, reducing costs, its all the same thing isn’t it? Actually, no it isn’t. Making obvious improvements should just be done and requires little or no effort and little skill to achieve. Lean manufacturing should focus the business on time based competition, that is making things faster, more reliably and ultimately this will reduce costs. Notice that lowering costs is one result of lean manufacturing. The real focus in lean manufacturing is superior customer satisfaction through time based competition.
Why is time based competition so important?
Time based competitors have distinct advantages over other competitors since for every quartering of total completion time, they experience a doubling of productivity and reduce costs by 20% At the same time they enjoy three times the growth rate of competitors and double the profit margin. This is achieved through a relentless focus on what is of value to the customer
For a process operator access these benefits, they have to implement a sustained and structured lean manufacturing initiative which addresses the following key features of lean;
- Value
What does the customer value? Without knowing this, how can you ensure that value is added and delivered to the customer? The lean journey is always from the customer perspective, since focusing on this the customer values is the best way to ensure business activities generate a profitable return - Value Stream
Mapping how and when value is added to the product enables the business to focus all efforts on doing things the customer values. Mapping the value stream is about more than just the physical activities, it encompasses all of the information flows, all work in progress, everything required to create and deliver the product and / or service the customer needs - Flow
What is the most efficient way to join two points? A straight line, in the same way it is important that materials flow in one direction through the process. The flow should always be from raw materials to delivery of finished product, with minimal work in progress. - Pull
In an ideal manufacturing environment, materials are pulled through the process by demand from the ‘customer’ rather than having materials pushed into the next process regardless of whether to not they are needed. - Perfection
A continuous improvement approach should be adopted, always looking to create additional value in the process,. this should be done either through incremental changes or through a major step change.
Most ‘low hanging fruit’ is of value from the perspective of the supplier’s costs, not from the perspective of customer value, so whilst it is valuable and important to address these losses, it does not replace a lean manufacturing implementation.
Start with understanding value from the perspective of the customer, map the process as it is (current state VSM), then map the process how you would like it to be (future state VSM). Construct a plan to modify the process from current state to future state, taking into account the financial and personnel resources needed to when declaring a timescale. This is then used as a blueprint for the lean transformation.
Lean is a structured, rigorous, disciplined process requiring dedication, focus and hard work to deliver profound and sustainable improvement in the time based competitiveness of the process, leading to improvements in
- Process cycle time
- Waste
- Lead times
- Customer satisfaction
- Turnover
- Margin.
Three Simple Questions…
A behaviour I suspect many lean six sigma mentors have seen with new belts is paralysis by analysis. Newly qualified, with access to powerful statistical analysis software and on their own for the first time, their first reaction is to conduct every statistical test they can think of, working on the principle that they are looking at the data from every perspective. What they are actually doing is in part showing off their new found skills and in part showing off their unconscious incompetence. That is not to say they are incapable, only that they lack experience.
When mentoring new belts I always start them out with three simple questions.
The reason for these questions is to make sure that they learn what I believe is one of the most important skills in lean six sigma; focus. I have noticed over many years that when belts who are new to statistical analysis gain access to a powerful statistical analysis package.
So back to the questions. The first question is this;
1. Can you write a simple statement of what you want to know?
It may seem obvious, but often people forget the first discipline of six sigma – DEFINE.
Starting analysis without actually stating what you want to know leads to confusion. It is all too easy to conduct a series of statistical tests then when the results are available find you can’t remember what you originally set out to discover. Let’s be honest, most of us have done it and had to start again, that’s how we learned not to do it.
It is for this reason that I tell anyone starting to do statistical analysis, do nothing until you can write a simple statement of what you are trying to discover. If you don’t know what difference or correlation you are trying to discover, how can you possibly choose a suitable test? We all suffer from a cognitive bias that makes it easy to believe we know what is required. However, if we can’t write it down simply, and in plain language, do we really know what we are trying to discover?
Having written down our question in plain language we need a way to answer our question. This leads to the second question;
2. How will this test answer the question posed above?
There must be a direct link between the analysis undertaken and the purpose of the test. For example if we want to know if changing a pigment gives the same colour for a particular application, we should consider how the testing has been done. If the tests are done side by side in a laboratory on the same piece of substrate and the results are normally distributed without outliers, a paired t-test would be appropriate. However if the testing occurs in different factories on different batches of substrate and the results are not normally distributed with outliers, Moods median test should be used.
The context of the data has to be considered when deciding which test to use. Again, the test selection and the logic for selecting the test should be written down in plain language. If you cannot do that, you have not adequately considered your test selection and should revisit your thought process.
So now we have a clear picture of what we want to know and what test should be done to answer that question. What else is required?
3. Write down the rules for interpreting the test.
It is vital that the rules for interpreting results are written down before the analysis is done. If an alpha level of 0.05 is selected and the p-value from the test result is 0.93, the test fails.
Remember the cognitive bias from the problem definition? It appears here again; if we write the p value after conducting the test, we may decide that an alpha level of 0.1 is adequate. The interpretation of the test is different, because our decision making has been influenced by the results, the test acceptance hers hold is no longer objective. For example, if failure resulted in an expensive process change in a business with limited finance, going back to the pigment example, if the new pigment is lower cost it would be easier to accept a larger difference to push the change through. That may not satisfy the customers’ needs and may result in higher complaints and potentially higher costs in the long term. the combination of a desire to save money and an apparently small difference in performance will have seduced the operator into unconsciously compromising their standards.
How should the decision criteria be documented? That is the whole point and purpose of null and alternate hypothesis, but that is for another time.
Following these three simple rules will ensure clarity of purpose, that there is a rational link between the desired information and technique applied and that the pass / fail criteria are set objectively. Following these simple rules for data analysis will save a lot of time and help the practitioners to become confident and productive in a shorter time.