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Advice You - The Use and Abuse of OEE
What is OEE for?
The simple answer is “Improvement”. OEE is an improvement measure and is used as part of the improvement cycle. Unfortunately, much is made of the 85% ‘World Class Standard’ an arbitrary target found in the original TPM literature. Not only is this target out of date (Nissan in Sunderland are running welding lines at 92-93% OEE) it gives the wrong m
The simple answer is “Improvement”. OEE is an improvement measure and is used as part of the improvement cycle. Unfortunately, much is made of the 85% ‘World Class Standard’ an arbitrary target found in the original TPM literature. Not only is this target out of date (Nissan in Sunderland are running welding lines at 92-93% OEE) it gives the wrong m
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
essage. A customer has no interest in your OEE – that is an internal measure, which relates to your efficiency and costs. The customer is far more interested in a measure such as On Time In Full (OTIF) ie did I get my order? Running a manufacturing business on an arbitrary efficiency measure rather than a customer satisfaction measure is a recipe for disaster. The be
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
t use of an OEE target such as 85% is to recognise that if you are reaching that level and the customer is still not getting his orders on time, then you may have a capacity constraint.
OEE does not tell us if we have a problem, the customer does. What OEE does do is help us analyse the problem and make improvements. This is why Toyota use it as a spot measure on a
OEE does not tell us if we have a problem, the customer does. What OEE does do is help us analyse the problem and make improvements. This is why Toyota use it as a spot measure on a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
particular machine where there is a capacity or quality problem. Calculating the OEE of anything other than a discrete machine or automated line is pointless; we have far better measures of the efficiency of a factory or department as a whole.
OEE developed out of the need for improvement groups to have a way of measuring and analysing equipment problems as part of
OEE developed out of the need for improvement groups to have a way of measuring and analysing equipment problems as part of
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
heir Define, Measure, Analyse, Improve, Control cycle. OEE defines the expected performance of a machine, measures it and provides a loss structure for analysis, which leads to improvement. It can then be used as a tracking measure to see if improvement is being sustained ie if control is sufficient.
What does OEE measure?
At its simplest, OEE measures the Availabi
What does OEE measure?
At its simplest, OEE measures the Availabi
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
lity, Performance and Output Quality of a machine.
A machine is available if it is ready to produce, as opposed to being broken down or having some changes or adjustments made. The definition of availability allows for planned maintenance, when the machine is not meant to be available to production, but makes no allowance for changeovers etc. No machine with changeo
A machine is available if it is ready to produce, as opposed to being broken down or having some changes or adjustments made. The definition of availability allows for planned maintenance, when the machine is not meant to be available to production, but makes no allowance for changeovers etc. No machine with changeo
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ers can ever be 100% available. The reason for taking such a hard line is that changeovers are a major loss to both efficiency and flexibility, so the OEE analysis focuses attention on it by making no changeover allowances.
Performance efficiency measures the output during available time compared to a standard. Here there can be debate about what the standard output
Performance efficiency measures the output during available time compared to a standard. Here there can be debate about what the standard output
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
should be. A good rule of thumb is to make the performance calculation based on best known performance. This may be greater or less than design speed. My argument is that if a machine has never reached its design performance it is not helpful to measure against that. On the other hand, if it has consistently out performed the design spec you can have (and I have see
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
) performance figures of 140%, which can hide poor availability. This is always remembering that one purpose of OEE is to help tell you if you have the capacity to meet customer demand.
Output Quality is a First Time Through measure – what percentage of the output was right first time, without any rework. FTT measures are always the best quality measures. The issue
Output Quality is a First Time Through measure – what percentage of the output was right first time, without any rework. FTT measures are always the best quality measures. The issue
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
in OEE is that sometimes the quality feedback is not immediate. In FMCG businesses, a customer complaint can be received three months or more after production. In these cases it is best not to include quality in the OEE calculation and use a more customer focused measure for quality – number of complaints etc. If there is no way we can use the Quality component of OE
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
in a real time improvement cycle, then it is pointless to measure it.
Loss Analysis
The next level of analysis is the seven (or six or eight or sixteen) losses. Within OEE we usually talk about seven losses, although TPM loss structures have been known to define 23 losses in all.
Availability losses are primarily Breakdowns and Changeovers. Changeovers can be sep
Loss Analysis
The next level of analysis is the seven (or six or eight or sixteen) losses. Within OEE we usually talk about seven losses, although TPM loss structures have been known to define 23 losses in all.
Availability losses are primarily Breakdowns and Changeovers. Changeovers can be sep
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
rated into Tool changes, Material changes and Reduced Yield at start up, but fundamentally these are the same issue. Further analysis reveals breakdowns to have two fundamental types, those due to deterioration because of inadequate maintenance and those due to inherent machine characteristics.
This gives us three basic responses to availability issues – improve cha
This gives us three basic responses to availability issues – improve cha
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ngeovers through SMED, improve basic maintenance and improve machine characteristics. Depending on the Pareto analysis of losses we may need to act on one, two or all three of these.
Performance losses are usually separated into speed loss and minor stops – is the machine running slow, or is it stop-starting? The definition of minor stop is also open to debate – ori
Performance losses are usually separated into speed loss and minor stops – is the machine running slow, or is it stop-starting? The definition of minor stop is also open to debate – ori
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
inally it was less than ten minutes, then five minutes, then three minutes. The pragmatic approach is to say that if you can measure the amount of time lost for a stop it is a breakdown, not a minor stop. If you can only record the quantity of stops, then they are minor stops.
There is some practical use for the speed/minor stop distinction – if a machine is running
There is some practical use for the speed/minor stop distinction – if a machine is running
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
slow we can always speed it up, whereas if it is jamming we need to look at the physical mechanism and try to remove the cause of the jams (my favourite example is where we found the root cause was when metal washers were being loaded into a hopper with a metal shovel, which damaged some, which then jammed the feed – the solution was a plastic shovel!).
We can howe
We can howe
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
er also make a useful distinction between performance losses due to deterioration or contamination and those caused by inherent machine characteristics. As with breakdowns this gives us two improvement approaches – better maintenance or equipment re-design.
Improvement
The only reason to measure and analyse anything is to improve it. If we are not going to use the
Improvement
The only reason to measure and analyse anything is to improve it. If we are not going to use the
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
whole improvement cycle there is no point in measuring OEE. It tells us nothing we do not already know. At a gross level all OEE tells you is how much you made compared to what you wanted to make, and any schedule adherence measure would tell you that already. Averaging OEE’s over whole plants or time periods just hides issues – OEE is a specific measure for use in s
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ecific improvement projects.
The biggest misuse of OEE is to use it to compare different processes, plants or machines. OEE is not a useful executive KPI. It is not even a very useful operational measure. It is an improvement measure, for people who want to improve their equipment performance.
How to massage your OEE
1) When the machine breaks down, log it to plan
The biggest misuse of OEE is to use it to compare different processes, plants or machines. OEE is not a useful executive KPI. It is not even a very useful operational measure. It is an improvement measure, for people who want to improve their equipment performance.
How to massage your OEE
1) When the machine breaks down, log it to plan
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ned maintenance
2) Do changeovers during planned maintenance or at weekends if not 24/7
3) Use an easy performance standard
4) Measure the best machine and quote that figure
5) Set arbitrary targets and achieve them through the above
Using the above strategy you should be able to report decent OEE’s and even make some money if pay is OEE performa
2) Do changeovers during planned maintenance or at weekends if not 24/7
3) Use an easy performance standard
4) Measure the best machine and quote that figure
5) Set arbitrary targets and achieve them through the above
Using the above strategy you should be able to report decent OEE’s and even make some money if pay is OEE performa
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ce related. What this will not do however is improve your ability to meet customer demand.
How to improve performance
1) Measure against customer demand (OTIF or similar)
2) Measure OEE on constraints or problem equipment
3) Set realistic performance standards
4) Analyse losses to identify issues for improvement
5) Use the whole improvement cycl
How to improve performance
1) Measure against customer demand (OTIF or similar)
2) Measure OEE on constraints or problem equipment
3) Set realistic performance standards
4) Analyse losses to identify issues for improvement
5) Use the whole improvement cycl
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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