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What are the best ways to develop and implement laboratory quality control measures?

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Quality control (QC) is essential for any laboratory that conducts research and development (R&D) activities, as it ensures the accuracy, reliability, and validity of the results. However, developing and implementing effective QC measures can be challenging, especially in a dynamic and complex R&D environment. In this article, you will learn some of the best ways to design and apply QC methods that suit your R&D lab's needs and goals.

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1 Define your QC objectives

The first step to developing and implementing QC measures is to define your QC objectives, which are the specific standards and criteria that you want to achieve and maintain in your R&D lab. Your QC objectives should be aligned with your R&D objectives, as well as the requirements and expectations of your stakeholders, such as customers, regulators, partners, and funders. You should also consider the characteristics and limitations of your lab equipment, materials, methods, and personnel, and how they affect your QC performance.

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Michael March

Director of Product Management | Product Development, Research and Development, Commercialization
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First off, the overall goal of any project is to succeed in the real world. This is where working with your customer and learning their priorities will save you enormous headaches. Identifying your Critical to Customer (CTC) qualities starts with success / failure feedback and works backwards towards properties you can measure and (hopefully) control.

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2 Choose your QC tools and techniques

The next step is to choose the appropriate QC tools and techniques that will help you monitor and evaluate your QC performance. There are various QC tools and techniques available, such as checklists, charts, graphs, statistics, audits, inspections, calibrations, validations, and verifications. You should select the ones that are relevant, feasible, and cost-effective for your R&D lab, and that can provide you with meaningful and actionable feedback. You should also document your QC tools and techniques, and train your staff on how to use them correctly and consistently.

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Michael March

Director of Product Management | Product Development, Research and Development, Commercialization
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Once you've established your Critical to Customer parameters, the next step is tracing those traits to something you can measure. Typically this means breaking down a larger user experience to something fundamental and is specific to the product or project. If your customers want a glue that "sticks great," you can identify their target substrates and test the force required to break the interface. If they want a glue that "lasts forever" you may want to evaluate the same adhesion after thermal or UV cycles.

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3 Implement your QC plan

The third step is to implement your QC plan, which is the systematic and documented process of applying your QC tools and techniques to your R&D activities. Your QC plan should specify the roles and responsibilities of your staff, the frequency and scope of your QC checks, the methods and criteria of your QC evaluations, and the procedures and records of your QC actions. You should also communicate your QC plan to your staff and stakeholders, and ensure that they understand and follow it.

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4 Monitor your QC results

The fourth step is to monitor your QC results, which are the data and information that you collect and analyze from your QC checks and evaluations. You should use your QC tools and techniques to visualize, summarize, and interpret your QC results, and to identify any trends, patterns, anomalies, or deviations from your QC objectives. You should also compare your QC results with your R&D results, and assess how they affect the quality and reliability of your R&D outcomes.

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5 Improve your QC processes

The fifth step is to improve your QC processes, which are the actions and decisions that you take to address any issues or gaps in your QC performance. You should use your QC results to identify the root causes and effects of any QC problems, and to formulate and implement corrective and preventive measures. You should also use your QC results to identify the opportunities and benefits of any QC improvements, and to plan and execute continuous improvement initiatives. You should also document and communicate your QC improvements to your staff and stakeholders.

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6 Review your QC system

The final step is to review your QC system, which is the overall structure and function of your QC objectives, tools, techniques, plan, results, and processes. You should conduct periodic and comprehensive reviews of your QC system, and evaluate its effectiveness, efficiency, and suitability for your R&D lab. You should also solicit and incorporate feedback from your staff and stakeholders, and benchmark your QC system against best practices and standards. You should also update and revise your QC system as needed, and ensure that it remains relevant and responsive to your R&D needs and goals.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Diane McClurg

HCA Retired Lab Director
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In my experience , QC with the upgrades in hospital instrumentation , basically does the QC review with alerts when the QC is not in. Unfortunately, unless the laboratory is doing a lot of manual tests, today’s medical technologists are not as well versed re quality control .

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What are the best ways to develop and implement laboratory quality control measures?

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1 Define your QC objectives

2 Choose your QC tools and techniques

3 Implement your QC plan

4 Monitor your QC results

5 Improve your QC processes

6 Review your QC system

7 Here’s what else to consider

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