Lean

Waste in Laboratories

Tom Reynolds — Thu, 17 Jan 2019 21:46:01 +0000

Published by Tom Reynolds in Lean Laboratory on January 17, 2019

Laboratories are not the same as manufacturing environments so do the standard Lean ‘Wastes’ even apply in Labs?

The term ‘Lean’ was first coined in 1990 to describe the manufacturing approach being used in Toyota factories in Japan. The “Toyota Production System” (or TPS) as it was called locally had been developed mostly by Taichii Ohno a mechanical engineer who rose through the ranks to become Executive Vice-president.

TPS shifted the focus of improvement initiatives from individual machines and their utilisation, to the flow of the product through the total process. Toyota understood that they could create ‘flow’ and reduce waste by lining their machines up in process sequence, developing quick set-ups (so that each machine could make small volumes of many part numbers) and by having each process step notify the previous step of its current needs for materials (i.e. pull). This in turn made it possible to achieve low cost, high quality, and rapid throughput times with high product variety.

“Add Nothing But Value” (Eliminate Waste)

In developing the Toyota Production System, Ohno identified 3 primary wastes - Mura, Muri and Muda in Japanese and seven (now famous) sub categories of Muda. Elimination of these wastes is the basis of most lean projects but are they relevant in the Lab environment?

Mura

Mura (unevenness) is the waste associated with volitile workloads. If anything, Mura is even more significant in Labs than in traditional manufacturing. In most labs there is short term volatility in the incoming workload with significant peaks and troughs. More often than not, this volatility is imported directly into the testing process which causes low productivity (during troughs) and poor lead time performance (during peaks). Levelling a volatile workload is perhaps the single most valuable thing that can be done when leaning a lab.

The simplest levelling strategy is to create the ability to process samples at the 'levelled demand rate' quickly (via flow). This reduces the 'throughput' time and incoming samples can then be held in a 'levelling queue' at the start of the process and released into the lab as part of a level daily volume and mix.

Muri

Muri (overburden) is the over loading of people or equipment. In Ohno’s world this included physical strain. In Labs a form of Muri is often directly caused by Mura when analysts are overloaded in an attempt to deal with peaks in the workload. ‘Muri’ can be avoided via levelling and defined analyst roles based on a repeating sequence of testing that meets levelled demand. It can be done!

Muda

Muda (waste) – Muda is any activity that doesn't add value (as defined by the customer). Ohno defined 7 forms of Muda and while most of these can be found in Labs, individual wastes may not be as significant in a Lab context as they are in manufacturing.

A cautionary note: The significance of Mura and Muri is often misunderstood and underestimated and many Lean Lab projects focus only on the Muda. There is a simple reason for this, waste is easy see and understand and tools like Value Stream Mapping help identify lots of new wastes to work on. Whereas tackling Mura and Muri is much more challenging particularly in Labs.

Eliminating waste from a levelled flowed lab process, instead of at isolated points creates processes that need less human effort, less space, and less time to test samples at less cost and with fewer errors and test failures, than traditional labs. Lean labs are also able to respond to changing customer priorities with fast throughput times.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.

Why can't my department get ahead and be productive

Andrew Harte — Tue, 09 Oct 2018 20:27:51 +0000

Published by Andrew Harte in Lean Laboratory, Lean Manufacturing, Lean QA on October 9, 2018

In operations where the short interval (e.g. daily or weekly) workload varies, the most common method of distributing the work is to share it equally between the available people. We call this method “available work through available people”. The consequence of this approach is that even low daily workloads expand to fill the day resulting in poor productivity. Carefully designed standard work can improve your department’s performance by consistently making the most out of people’s time.

Consider the situation of the perennially under performing department. Over the last 3 years headcount has increased by 30% but the workload has stayed the same. The allegedly “temporary” staff hired in to help with peak workloads have now been in place for over a year. Even more upsetting is that the departments’ performance and turn around time have not improved despite this increase in staff. They’ve tried dedicating resources to specific tasks and although this improved the output for individual tasks within the department, overall performance did not improve, if anything the metrics got worse. (see Small dedicated work groups). The department has a volatile workload and just can’t seem to get ahead even during sustained lulls in work loads. The problem is that this department is suffering from a phenomenon known as Parkinson's Law: i.e. Work expands so as to fill the time available for its completion.

Consider the following situation. A department with 5 staff, each of whom can contribute 7 work hours per day, has capacity each day for 35 hours work. For the amount of work the department gets each month 5 people should be more than sufficient. But the departments’ performance is not up to scratch. There are constant backlogs and throughput times are not meeting targets. Daily the department receives 25-45 hours of work, but never seems to catch up on itself. A closer inspection of the way the department is organized reveals that each days work is spread evenly among the staff. Available work to available people! While this sounds like the fairest way to distribute work, it is actually one of the reasons that the department is not performing.

Adding staff to improve performance will have limited impact here as the same work load now gets spread among more people giving diminishing returns. This will also increase the percentage of days where the staff are unproductive because the available work is less than the available resource. On top of this, with work spread thinner, people get used to doing less and less so an individual’s work capacity can actually decrease.

The problem with available work to available people is highlighted in the graph below. There are only 3 possibilities:

The amount of work received is below the capacity of the department, in which case the staff are underutilized and hence unproductive.
The amount of work received is above the department’s capacity, which carries penalties of increasing backlogs or overtime or both.
The amount of work matches the department’s capacity. Unless the process has been specifically designed to deliver this amount of work every day (see BSM rhythm wheel, trains, leveling queues), then it is only random luck when the amount of work actually matches the department’s capacity.

Image

Believe it or not there is a way to increase the department’s productivity through careful design. Standard work is one of the keys to unlocking the productivity and performance of this department. Standard work can increase productivity without overloading staff. Standard work is designed to be a productive days work, that fits tasks together in the optimum way so as to make the best use of people’s time. Feedback from staff where standard work is applied is always positive. This is because it is rightly perceived as being fair and balanced and designed to accomplish tasks with the minimum amount of effort.

Imagine in the above situation that the department switches away from available work to available people towards standard work. In this case each employee gets 7 hours of standard work. On days where there are only 25 hours work available, this will occupy 3.6 employee’s, freeing up 1.4 to deal with backlogs, training, improvement projects or long lead time work or projects. In the previous system where work was spread equally among staff, everybody was always occupied. With standard work the department will frequently have “free” resources that can constantly chip away at backlogs or improvement projects. On days where there is more than 35 hours work, the department can guarantee that 35 hours will consistently be delivered, without overburdening staff and the excess can be held over until the next sub 35 hour day.

Of course the right thing to do is to level the workload so that short term volatility is not an issue. BSM have proven methodologies such as rhythm wheels, trains and leveling queues that can level workloads and allow companies to unlock the productivity that is wasted by volatile work loads. When combined with standard work these tools can turn an under performing department into one which is consistently meeting and beating it’s targets.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.

Lean Organisation for Lean Programmes

Pat Sheehan — Wed, 11 Apr 2018 16:26:47 +0000

Published by Pat Sheehan in Lean Programs on April 11, 2018

Here’s the Scenario: You’re a site leader three months into your Lean Programme and on the face of it things are going well but you’ve got doubts that the organisation structure is supporting your lean journey in the way you’d want. These are some of the contradictions that you see.

For the first time you’re measuring OEE, you can see your Pareto of losses and the production team are busy applying SMED to reduce changeover times… BUT your engineers still see themselves as a service to production, they measure KPI’s that are not aligned to OEE improvement (for example the number and age of open engineering work orders), technical expertise is spread too thin, they spend too much time on what should be autonomous maintenance tasks and they don’t attend the daily start of shift meeting to be appraised of the issues of the day.

Neither is your quality organisation best supporting your quest for continuous improvement; they spend 80% of their time auditing, reporting and issuing action lists and only 20% of their time actively solving problems.

The impact of demand volatility has been explained to you and you’ve helped design a fixed repeating levelled schedule that delivers flow and repeatability but your planners want to retain central control for planning and scheduling and insist on making planning more complicated than it really is.

Your newly designed Work Instructions (WI’s) are concise and user friendly but you rely on your already stretched production supervisor to train out the operators when she can. You’d like to have someone in a Team leader role spending 80% of his time managing this important standardisation activity.

Finally as a senior team you’ve got all the lean training and practical problem solving training you could wish for but you’re not actively solving problems with your team and you certainly don’t see yourself as being confident when it comes to teaching the Lean System.

It’s time to get serious about designing an Ideal Future Organisation Structure that really supports your Lean endeavours and integrates functions and activities in a way that maximises your continuous improvement efforts.

Here’s how you might go about this task

Establish the scale of the change you require

Think about dividing up the site into mini business units / value streams based on product family or technology to make them more manageable.
Decide whether you should examine all functions on the site or initially focus on integrating those that are closely aligned to day to day production activities (Engineering, Quality, Planning, HR, etc)?

Define and document the current organogram

This will bring a clarity to the task ahead (and probably prompt a lot of questions, like why on earth does this role exist, etc).

Identify possible opportunities for change - ask yourself…

How do I get more / better support in the areas I need it?
How do I design Roles that have more of a Lean Focus?
Suppose I had fewer planners, functional supervisors, QC auditors, etc, etc…what would that look like?
How can I avoid duplication of effort?
How can I simplify how issues are uncovered and resolved?
How can I improve focus and give more autonomy?
How will the senior team on site organise itself be best equipped to lead and teach the Lean system?
How do I create a better environment to work in for everyone?

Examine each opportunity in detail

Quantify tasks.
Assess the pro’s and con’s of the change and then Decide!
Compile Ideal Future Organisation (IFO) map.

Agree an Implementation Strategy

Should I go “Big Bang” or opportunistically over a longer period?
Prepare a detailed implementation plan.
Communicate, Communicate, Communicate!!
Prepare a roadmap with milestones for completion.

Tips to follow

Don’t try to reinvent the wheel – what you should end up with should resemble the Toyota Production System Model.
Designing an IFO is a task for the senior team not a lean project team.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.

Designing Visual Management for a Lean Laboratory

Noelani Roy — Wed, 11 Apr 2018 16:02:19 +0000

Published by Noelani Roy in Lean Laboratory on April 11, 2018

Visual management is an integral part of a Lean Laboratory. It unites personnel around a common goal, ensures that critical information is disseminated, and keeps the lab running smoothly. When a visual management board is well designed, anyone should be able to walk in and have a clear understanding of the labs operational status and current performance.

In order to design a sustainable and helpful visual board, ask yourself three questions:

What is the goal of the board?
Who will be using the board?
What information do they need to accomplish the goal?

Too much information can be the death of a visual board, so it’s important to focus on providing the key players the information they need to accomplish their goal.

The above board’s goal is to facilitate the movement of samples through the lab and therefore each board section is directly related to that goal.

The Lot Tracker section keeps track of which stage each sample is in. There is a landing queue for samples that have entered the lab but have not yet started testing. There is an In-Progress calendar which allows for easy scheduling of analysts to sample assays. After the scheduled completion of the testing, the sample can move into the completed stage. The Lot Tracker is helpful in three ways. It allows for easy scheduling of analysts to assays, it shows overall workload of the laboratory, and it shows which analysts have extra resources available.

The Daily Huddle Agenda is essentially a checklist to focus discussion at a brief daily meeting held at the visual board. The meeting is held at a time which is convenient for all personnel, typically at the beginning or end of the shift. At the meeting progress vs schedule is discussed and short term action items assigned with particular focus on resolving issues that arose during the shift.

The Investigation Tracker and the Problems / Issues Tracker are very similar. They give clarity to any issues happening in the lab and assign a responsible party and a timeline to make any corrections. Having deadlines (artificial or not) creates urgency when problems have a tendency to stagnate.

The Training Matrix is posted so that assays requiring more trained personnel are clearly visible to the entire laboratory. This empowers employees to train on assays that need more personnel and makes scheduling quicker for management.

Performance Metrics are a method of continuous plan, do, check, act (PDCA). Depending on what the goal of the laboratory is these metrics can be varied but should typically comprise one each in the areas of Quality, Delivery and Productivity. We normally recommend that only metrics which facilitate / identify short term interventions are placed on a daily visual board, such as number of samples within X days of lead-time. A separate board which looks at medium term performance and facilitates continuous improvement activity will be the topic of a separate blog.

Remember that a visual management board is not a one size fits all. Creating something that will benefit your team requires thought and input from all involved parties.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.

Synchronising Planning, Manufacturing & QC

Karen Wrafter — Thu, 10 Jun 2010 15:13:42 +0000

Published by Karen Wrafter in Lean Laboratory, Lean Manufacturing on June 10, 2010

Day to day operations of individual departments in life science companies rely on many decisions made outside of each department’s own remit. When embarking on a Lean strategy, the pillars of operational excellence (Levelling and Flow) can be supported by increasing awareness of how each department functions and explaining constraints.

Communication between Planning and QC

From the perspective of the typical QC department, raw materials seem to arrive for testing in a haphazard manner; and without an understanding of the underlying pattern it is difficult to implement an effective levelling strategy. The net effect is a volatile and unpredictable output of released material, creating difficulties for both the planning and manufacturing areas. The same is true of the downstream process, whereby a volatile output of released finished product can hamper plans to meet customer shipping requirements.

A good starting point in rectifying the situation is to quantify the workload associated with each raw material, in-process sample and finished product in terms of QC testing. At the very least, the planning department will no longer plan to use raw materials sooner than they can be tested; at best, the planning department can re-order their requirements to allow the same workload to enter the lab on a daily or weekly basis, enabling levelling, while at the same time satisfying the needs of the manufacturing area.

Communication between Manufacturing and Planning

In a similar situation to QC, manufacturing departments often operate in an unlevel manner. Availability (or unavailability) of raw materials can lead to preventable last minute revisions of manufacturing running orders, typically without consideration for available manpower, vessels or manufacturing durations. Quantifying the manpower required for manufacture provides crucial information to those involved in planning the manufacturing running orders. When cross-referenced against the available manpower, achievable manufacturing plans can be designed. (Note: it is important that the available manpower is aligned to the actual requirements).

Minimising the late revision of manufacturing plans ends the vicious cycle, whereby a manufacturing change requires a lab raw material scheduling change, which has a knock-on effect on the availability of raw materials required further down the plan, leading to further manufacturing plan revisions.

Communication between QC and Manufacturing

Where batch manufacture requires some laboratory input (e.g. in process pH or assay), it is important that the manufacturing department understand the testing workload involved, in terms of system suitability analyses and actual sample testing time. An achievable service level agreement (SLA) should be determined to allow the lab sufficient time to perform the testing, without interfering with on-going analyses, while meeting manufacturing needs. Realistic SLAs allow manufacturing to schedule “filler” tasks to ensure maximum productivity while awaiting results.

Conclusion

Open communication between all three functional areas is imperative while designing optimised lean strategies. With a levelled workload and predictable outputs the task of “flowing” the entire process is simplified and with increased transparency further opportunities can be identified.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.

Why are Lab SOPs and Work Instruction so Bad?

Karen Wrafter — Tue, 11 May 2010 15:35:23 +0000

Published by Karen Wrafter in Lean Laboratory on May 11, 2010

Typically, laboratory Standard Operating Procedures and Work Instructions are wordy, patch-worked documents and a hindrance to testing analysts and reviewers alike. Over their life cycle, procedures usually become increasingly difficult to decipher due to multiple disjointed revisions. As a result, training and routine testing often relies on the retained knowledge of key experienced personnel, with an accepted culture of ‘Chinese whispers’. This dependence on undocumented hints and reminders can be tackled by applying Lean thinking to the design and layout of Laboratory SOP’s.

Are SOPs really so bad?

It is not unusual for up to 70% of all LIRs (Laboratory Investigation Reports) and KLEs (Known Laboratory Errors) to fall into the human error category. A significant portion of these can be attributed to method deviations arising from unclear or ambiguous instructions. The primary CAPA (Corrective Action / Preventative Action) for such LIRs and KLEs is an update to the associated test method or standard operating procedure. Where as a pre-emptive strike in terms of “leaning” instructional documents could significantly reduce method deviations.

The demands of cGMP/GLP restrict the ease with which a controlled document can be updated. Content management platforms are often less than user-friendly effectively deterring SOP updates even when gaps or errors have been noticed. Instead, the inaccuracy is ignored until such time as an LIR/KLE driven CAPA requires it to be rectified.

So, why are SOPs so poor?

An all too common “compliance for compliance sake” attitude is usually to blame. SOPs are often written only to satisfy GMP/GLP requirements rather than as concise useful aids to testing which help reduce the risk of errors. The impact of poor yet sufficiently “compliant” SOPs on productivity does not get due consideration.

Often, SOPs are written by personnel with little or no direct experience of the task being described. This (less than accurate) account is passed along the chain of command for review by a supervisor or manager with even less direct experience. The resultant approved document goes through numerous avoidable revisions throughout its lifecycle as shortfalls are identified by confused end-users. SOP creation and upkeep are rarely scheduled in the same manner as routine laboratory testing and are generally squeezed in after tasks that are perceived as more important.

How to Lean SOPs and Work Instructions

Lean SOPs or Work Instructions provide a higher standard of instructional documentation. The Lean documents are inherently GMP compliant, but are developed with the needs of the end-user in mind rather than just those of the regulatory authorities. A SOP that accurately describes a task to analysts, in a manner easily interpreted by new users, will always satisfy the regulators.

Lean SOPs use photos and diagrams whenever possible, this eliminates subjective descriptions of instruments and machine parts. The benefits of pictures in lieu of verbose descriptions cannot be underestimated. Certain prohibitive practices contribute to the misapplication or omission of graphics in SOPs, e.g. the convention of printing controlled documents on blue paper which can reduce the contrast, the resolution and (by proxy) the value of coloured photographs and diagrams. The typical format of procedures (across the regulated industries) has not been updated since the advent of widespread digital photography. This is a significant missed opportunity.

Fig 1 - SOP Before

Fig 2 - SOP After

6 pages of disjointed, confusing text re-engineered to one page of logically sequenced pictures, diagrams and text. (Purpose, scope and change history are documented on the reverse side where they belong!)

Lean SOPs are written by personnel familiar with the task at hand and reviewed by someone unfamiliar with the specific procedure. The review takes place in the form of a “hands on trial”, supervised by the author. Where a step does not provide adequate instruction, an amendment is made. A similar “hands on trial” is carried out on the amended SOP in the presence of the approver (manager), after which time the document can be signed off.

Increased investment in the first draft of a document saves hundreds of hours over its life cycle, in the form of avoided LIRs / KLEs, reduced numbers of revisions and their associated review and approval requirements. Truly Lean instructions speed up the training process, reducing the effort for both trainer and trainee alike.

Our consultants can provide further information on the above and discuss any aspect of Real Lean Transformation, simply set-up a call today.