Optimizing QC Lab Testing: A Lean Approach

Optimizing QC Lab Testing: A Lean Approach

QC lab testing methods and overall testing strategies can often be inherently wasteful. How can we identify and eliminate such waste to optimize lab performance?

The biggest Lean opportunity in most labs is addressing short-term volatility in workload or sample mix (Mura). Tackling this by designing a system of operation based on levelling, flow, defined test sequences, and standard work is crucial. Once this is in place, continuous improvement efforts can focus on eliminating Muda (waste).

Waste in Lean terms refers to any activity that consumes resources without adding value. In labs, this can manifest as excessive planning, poor documentation, inefficient investigations, and various Non-Value Add (NVA) activities during testing. Below are key strategies to eliminate waste in the testing process:

1. Streamline the Overall Test Process

Designing standard work is essential. By documenting each step of a test, identifying non-value-adding elements, and establishing the most efficient methods, labs can reduce waste and improve analyst flow. Some areas to consider include:

• Improving Test Methods: Focus on tests that frequently fail and lead to wasteful rework.
• Extending System Suitabilities: Longer system suitability periods allow for greater sample batching and reduced numbers of test runs with the accompanying setup effort
• Prolonging Expiry Periods for Mobile Phases, Standards, and Samples: This allows for better batching, reducing effort and cost.
• Automating Lab Activities: Automation of sample preparation, testing, and analysis and write up of results reduces hands-on time for analysts.  
• Managing Consumables Efficiently: Use of pre-prepared solvents/reagents/media can be cost effective. Other ways to improve consumable management can be to centralize preparation and ordering and implementation of robust Kanban systems for replenishment.
• Creating Work Cells: Optimize lab layout to reduce motion waste and align with standard work roles combining tests which will often run together to optimize analyst time.

2. Combine Similar Tests into Single Runs

Often, different tests can be combined into single runs, reducing the number of necessary setups. For instance, if two products require HPLC analysis with similar mobile phases, columns, and conditions but differ in sample and standard preparations, a combined system suitability and analysis run can be designed to optimize both analyst and equipment time. Another example of this might be products which run on the same column/system but historically have been run separately. Developing sequences with flush steps and bracketing can dramatically improve sample loading and productivity, while reducing material waste.  

3. Eliminate Unnecessary Testing

Over-processing, or unnecessary testing, is a common waste in labs. To address this:

• Avoid Extra Testing Beyond What’s Required: Challenge the need for additional information-only testing, whether this is coming from production or stability studies.
• Improve Communication: For instance, if a manufacturing issue is detected after samples are submitted to QC, inform the lab to halt testing on those samples to avoid redundant testing.
• Streamline Test Methods: Eliminate overlapping methods, such as using both new and old degradation tests (e.g., HPLC and TLC) simultaneously. While this can be required for a short period of time to ensure regulatory compliance where multiple regulatory bodies are involved. Where possible, efforts should be made to align the implementation of the new methods, to reduce the ‘double testing’ requirement.
• Reduce Unnecessary Stability Time-Points: This can often occur when batches aren’t packaged soon enough after the initial assay, or if there is a delay in setting up stability studies.
• Implement Reduced Testing: This is particularly relevant for raw materials, where reduced testing should be applied to materials with a strong vendor compliance history.

While labs might be able to implement some (or all) of these projects it is important prior to starting any project to determine the potential time and cost savings and the ease of implementation. Most labs will only have a limited capacity for these types of projects so it is better to have a small number of focused projects which will have a measurable benefit. Projects should also be tracked and discussed regularly to ensure they are progressing, and the benefits will be realised. When waste has been identified and eliminated from the lab you should also revisit the appropriate standard work/roles and update to incorporate the benefits.

Ultimately, tackling both workload variation and process waste enables QC labs to significantly improve efficiency, reduce costs, and deliver faster, more reliable results.