lab capacity

The importance of ‘triage’ in variable effort work packages in quality control teams

Joe McCarthy — Tue, 27 Sep 2022 15:41:09 +0000

Published by Joe McCarthy in Lean Laboratory on September 27, 2022

“But our work isn’t predictable and changes every time!”

While in routine labs determining the work effort of a standard process step is relatively straight forward, for many other types of labs/teams there is a highly variable effort associated with apparently similar activities due to variance in the complexities.

Typically, these challenges are faced by groups such as, investigative labs, document control teams and project work based labs/teams, among others. Work in these teams typically have higher volatility in both volume and complexity coupled with challenges to meet service level agreements due to poorly defined timelines.

Fortunately, we can look to examples in other industries where these variable and unknown efforts in work packages occur routinely.

If you have been unfortunate enough to visit the emergency department of any hospital the first thing you will encounter is typically not your attending doctor but instead a triage nurse/doctor who first quickly assesses the severity of your issue (urgency) and what will be required to treat you (effort/complexity). Additionally, key facts will be noted about you to help the attending doctor get up to speed quickly with your personal circumstance and have flagged any potential complications early.

In a less dramatic sense the same methodology can be applied to variable effort work packages in quality environments.

The Triage Step

Incoming work is quickly assessed for complexity and work effort. Typically, this leverages structured and standardized forms (increasingly electronic) where the work package is quickly broken down to a sum of its smaller parts (for project work this is typically milestone based).
Key details are also recorded to enable the next person picking up the work to quickly get up to speed (e.g., key contacts, due dates, special considerations). Where possible, key concise details should be received from the customer in standardized form to expedite the triage.
Visual management techniques such as color coding and pictographs are employed to clearly show status/effort categories.
Triaged work packages are then added to a dynamic queue in priority order for assignment.

The triage step should be quick and as controlled and concise as possible while remaining fit for purpose.

This ‘triage’ step is a key enabler for the implementation of levelled workloads, through both the effort sizing of work packets and establishment of priority based queues. While the structured rule based approach to ensuring all required and relevant information is available before the work starts helps ensure flow through the rest of the process. Combining these steps along with visual management, resource allocation and workload tracking helps ensure that we can efficiently manage team capacity and productively meet required service agreements.

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

Understanding Lean Lab for Operations Excellence Teams

John Larkin — Wed, 19 Aug 2020 22:38:15 +0000

Published by John Larkin in Lean Laboratory on August 19, 2020

During a lean Lab project, 2 of the questions frequently heard from non-QC stakeholders are:

Why such a strong focus on workload levelling in QC’s Lean Lab project?
If it doesn’t take X days to physically test a sample, why does QC need this much lead time?

Operations Excellence teams typically have prior experience of applying lean tools in a production environment, and achieve significant improvements with techniques such as Value Stream Mapping, OEE & TPM, SMED/Changeover improvement, Pull/Kanban, Standard Work, etc.

An effective production operation is typically applying the key lean principle of workload levelling (Heijunka), though they may not consider this to one of their key lean tools. For example, if Production Operation A has a capacity of 5 x batches per week, Scheduling will not plan 2 x batches in Week 1, and 8 in Week 2. Workload levelling is the result of effective capacity management & production scheduling. As a result, and though it is a core lean principle, it is intuitive to most production environments.

In the real world, lab capacity is not a primary (or even secondary) consideration of the production scheduling process. But even if it was, QC Labs are downstream operations, with incoming samples from multiple workstreams – finished product, in process, stability, raw materials, environmental, etc. It would appear inevitable that incoming QC workload will be volatile, and experience tells us that this is invariably the case. To provide the lab with the opportunity to be productive, the most important 1^st lean step is to level the lab workload.

Lab capacity is not so readily defined. To quantify, one feature to be considered is the impact of sample grouping. Though the impact varies by test type, the illustration highlights the potential impact of sample grouping using a typical HPLC test run. Whether looking at Analyst work content, or capacity (of Analyst or equipment), the impact is very significant.

QC requires some lead time in order to:

Level workload within the lab
Leverage the productivity & capacity benefits of grouping samples on test runs

Of course, service level is a key deliverable in any lean lab project, and the business will not tolerate poor lead time performance in order to deliver benefits elsewhere.

When designing lean lab solutions, a key design target is to be as productive as possible, while delivering consistently against the lead time targets of the business.

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

Surge Capacity in Labs

Tom Reynolds — Fri, 17 Jul 2020 11:25:14 +0000

Published by Tom Reynolds in Lean Laboratory, Lean Manufacturing, Lean Programs on July 17, 2020

A good design will accommodate all known and predictable workload volumes and volatilities. This will include non-routine, event or issue-based workloads that, based on recent history, can reasonably be expected to occur at some point. However, it will not normally include spare resources for exceptional or unprecedented spikes in workloads as this can involve carrying significant extra cost. Also, because the extra resources tend to get absorbed into the routine operations, it can actually reduce on-going productivity.

A better approach therefore is to create a defined plan to rapidly increase short term capacity. This should be done ahead of time rather than trying to solve the problem from scratch when there is a sudden increase in Lab Workloads. A ‘Surge Capacity’ plan should identify incremental strategies to quickly increase the lab’s short-term capacity and be agreed in advance with all relevant stakeholders.

What is a surge? - A surge is when the short-term Lab workload (i.e. the demand) is significantly above the normal capacity of the Lab
Surge Capacity is the ability of a lab to rapidly increase its short-term testing capacity above the normal capacity / levelled demand rate.

Typical causes of Surges in Demand

Event Based:

Surges in demand can occur due to exceptional events that generate additional testing workloads above the normal routine testing. Examples of this include

‘Positive’ Micro Events (EM blooms / Sterility issues / Media Run failures etc.)
Manufacturing Equipment Issues and associated validations / re-validations
Adverse Events – Support for Investigations

Testing Backlogs:

By Definition a Backlog can only occur if the rate of testing falls below the incoming demand for a period of time. Equally, a backlog can only be cleared if the rate of testing exceeds the incoming demand for a period of time. Common reasons for testing backlogs include:

Lab Equipment failure or failure of the Test
Insufficient Analyst resources to test at the levelled demand rate. For example due to:
- Vacation Season
- Long term absence (your lab process design should include cover for normal short-term illness)
- Exceptional short-term absence (e.g. flu season / your country wins the world cup)

Changes in Demand:

There can be significant increases in testing workloads due to unpredicted or uncommunicated increases in production volumes. The changes may be short term or temporary - for example if Production are building stock to cover a planned shutdown or longer term -for example if the sales demand for the product has increased. If the increase is permanent or long term, the levelled demand for the lab should be re-calculated and the process re-designed. The lab resources should be permanently increased based on the new levelled demand. Surge capacity can be used to cover an interim period while this is happening or if the change to demand is short term.

Constraints on Lab Capacity

The Capacity of Labs is normally constrained by

The amount of trained Analyst Resources available (measured in Analyst hours per period or FTE
The availability of Test Equipment (measured in System Hours per period)
The operating hours and days (e.g. 8/5, 24/7)

Generating additional capacity to deal with surges in workloads will normally require temporary increases in some or all of these constraints.

Creating Surge Capacity

At its simplest, you can only increase lab capacity by having more and/or larger runs. Of course, enabling larger or additional runs usually requires addressing some or all of the common lab constraints.

Larger Runs will sometimes require additional analyst resources (the increase in the work content for each run may require an additional analyst to do some of the tasks).

More runs will typically require additional analyst resources plus extra equipment hours and/or increased hours of operation.

Increasing Testing Analyst Resources

Options for temporarily increasing the availability of analysts to support more or larger test runs include:

Temporary Suspension of non-testing activities e.g.
- Project Work
- ‘Non-Test Tasks’
Temp Transfer of Analysts from other Labs or sites
Annualised Hours contracts / increased hours from part time people
Simple overtime

Increasing Equipment Resources (i.e. available system hours)

In the short term, it is not usually feasible to source, buy, install, validate and / or qualify additional equipment. Therefore, the most viable option for temporarily increasing the availability of equipment is to temporarily extend the lab’s hours of operation. This can be done via

Overtime
Modified, Extended or Additional shifts
Weekend working

Note: If the equipment already runs unattended into the “off shift” (e.g. HPLC systems). The additional shifts will need to cover the time after the run finishes.

Other Options

In some circumstances, it may be possible to transfer surge volumes to other entities. For example to:

To other labs on the site
To other sites within the company
To specialist contract testing labs

This would obviously require prior qualifications and approvals to be in place.

Defining a surge capacity Process / Plan:

Evaluate the risk of Surges in Workload in your lab related to each of the common causes and their potential impact on testing capacity

Test Backlogs - Equipment Failure:

For each key piece of equipment evaluate:

What is the likelihood of a significant failure in the next 12 months? (you can use historical data to inform your opinion)
How much redundancy do you already have? (i.e. compare the demand in system hours v the capacity in system hours)
How long will it take to repair (what is the service level agreement with your supplier)

You can then score the risk as follows:

Risk Score = % risk of occurrence x likely downtime (in working days)

% of Demand in Equipment Redundancy

Example 1: A 20% risk of failure in the next 12 months x 10 working days to fix / 40% existing redundancy = 5
Example 2: A 10% risk of failure x 10 working days / 80% existing redundancy = .125

For equipment with higher scores, consider investing in additional redundancy and / or define a specific surge capacity strategy

Event Based:

For each potential cause of extraordinary workloads (e.g. Sterility positive, unplanned validation studies, major investigations etc.)

What is the likelihood of a significant event in the next 12 months? (you can use historical data to inform your opinion)
How much extraordinary work is an event likely to create (in additional test runs & associated effort or equipment time)

You can score the risk as follows

Risk Score = % risk of occurrence x additional work (in analyst testing days)

Example 1: a 20% risk of occurrence x 10 analyst days of extra testing = 2
Example 2: a 10% risk of occurrence x 10 analyst days of extra testing = 1

For events with higher scores, define a specific surge capacity strategy.

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