LEAN INNOVATION IN A QUALITY CONTROL LABORATORY

LEAN LABORATORY CASE STORY

THE BRIEF

The QC lab of a leading pharmaceutical company was struggling to meet the needs of its business. Their site produced, packed and shipped drug product for a wide range of specialist treatments, ranging from treatments for transplant patients and Parkinson’s disease to chemotherapies.

Manufacturing operations was managing to meet the demands of the relatively high mix, but the analytical lab was stretched trying to cope with release and stability samples, along with other testing requests, and was viewed by the business as being “unreliable” in meeting its due dates.  ‘Customer service’ meetings were being held daily to try to expedite orders, so changing priorities complicated things further, with dozens of batches regularly starting test, then stopping, then starting again.  It was a vicious circle resulting in long and variable leadtimes … and it wasn’t just customers who were frustrated…

Supervisors were frustrated at time wasted planning and re-planning, and having to set up instruments for small, unproductive test runs.  Analysts were frustrated by the constant changes … and never knowing what to work on next.  Backlogs were building up.  Mistakes were made.  Leading to further stress at the daily meetings.  The QC manager was begging for more resources, but Finance didn’t have the budget…

“No one signed up to this on the first day.  We studied to be scientists – we hoped to contribute something of value to one of the world’s largest pharmaceutical companies … but we are trapped in a world of chaos… and there doesn’t seem to be any light…”

THE APPROACH

ARTICULATE YOUR VISION AND BUILD TRUST

A team got together comprising the QC Manager, QC Supervisor, Lab Technician and Senior Analyst. This core group of four each had working relationships with all relevant stakeholders in QC, QA, Operations and Logistics, and would provide monthly progress updates to the senior site leadership.

We facilitated the team, together with key business stakeholders, in articulating the need for change, and developing a shared vision for the future state, including goals for service level commitments between QC and the business. This laid the foundations in developing trust between QC and its stakeholders, and confidence in the project as a transformative process innovation.

Once the parameters of the process innovation were laid out, the next step was to identify the Key Decisions that needed to be made, and what knowledge/learning was required to make them.  We held a kick-off workshop in which the team articulated decisions such as: “What is our optimum testing strategy?”, “How will we manage/queue arriving samples?”, “How will we ‘flow’ samples through all tests to be on time?”, “How will we easily manage/control all of work on a daily basis?”, “How will we measure success?”.

In order to gain the necessary knowledge to make each decision, the team set up learning cycles, involving colleagues with expertise from relevant areas of the business, and supported by our expertise in lean lab practices.

LIST KEY DECISIONS AND START LEARNING

LEARNING

CYCLE

MENTORING

We provided mentoring and guidance for the sub-teams in charge of each learning cycle in leveraging techniques that are central to lean innovation in labs.  For example, analysing readily-available lab data revealed historic patterns of work arriving into the lab, and provided a deeper understanding of the nature of workload volatility and mix.  This guided the team in developing, for example, an appropriate testing strategy.  The data also allowed us to model and predict test run sizes to meet leadtimes, while optimising the use of instruments.

Visual queues and control are also central to a lean environment, so these principles were demonstrated through the learning cycles.  The supervisor had been trying to control and manage all work allocation via a spreadsheet, but when a visual planning card was trialled as part of an early learning cycle to decide “How will we manage/queue arriving samples?”, he promptly abandoned his spreadsheet, and a large visual board within view of the whole lab quickly became the nerve-centre of lab planning!

With optimum run sizes established, the team was able to confidently set out sequential and parallel days of “standard work” for all testing, for defined numbers of samples, with defined, short throughput times for these samples.  Each product therefore, had its defined ‘test train’.  So, samples arriving could queue by joining the relevant train (represented as cards on their new visual board), and launch in a controlled way into the lab, triggered either by number of samples on the train, or by a “must start date”.  Testing was then carried out in full confidence that trains would ‘arrive on time’ at the other end… and all stakeholders could see their progress clearly with one glance at the board!

PREDICTABILITY, CONTROL, CONFIDENCE

THE IMPACT

Within 10 weeks of setting out their vision, and thanks to an enthusiastic adoption of the accelerated learning approach, the QC lab had already transformed its standing as a service provider to its customers.  This was down to the success of early trials of testing trains for its highest volume products – median leadtimes were drastically reduced (by as much as a third), and more importantly, ALL release batches for these products were being turned around in a predictable, guaranteed leadtime.  But what about the rest?

At their 20-week project results review the team proudly presented some staggering statistics.  From being 54% on-time to the business for testing of release samples, they showed that only 4 release batches of the 333 they had tested had exceed their target leadtime.  But the business didn’t need to see this presentation – they already knew that there had been a transformation – it was evident for the past several weeks of customer service meetings, where peace, harmony and joy now reigned!

Back in lab, the new sense of being in control inspired other things.  Coming to work was now a joyful experience.  The supervisor’s role as a daily expeditor was gone, and he was now managing a team that was able to perform its routine testing far more productively.  And the predictability of standard work in defined ‘trains’ had all but eliminated lab errors.

Everyone in the lab now had space and time to think, so when another site in the network raised its hand because they were in trouble with a large stability backlog, the network stood up and took notice when the lab that had only ever had a name for ‘struggling’ to meet its own site’s needs, now raised its hand to help another.  The first delivery of stability backlog samples arrived a month later… and at the end of the year, the QC manager was invited to share her story with the network at the company’s annual assembly!