The 2023 Guide to introducing a laboratory Quality Management System

Have you been tasked with introducing a laboratory quality management system? Do you feel overwhelmed by the task? Do you already have a laboratory quality management system in place but don’t know how to improve it?

This article will cover the importance of quality management in laboratories and how to ensure you have the basics at least covered.

What is a quality management system?

A quality management system allows companies to meet their customer expectations and creates a framework of continuous improvement to deliver more value over time.

If you would like to know a bit more about this topic, I have introduced in a different post what a quality management system is in more detail in a separate post.

Why does a laboratory need a quality management system?

This is not manufacturing, right? Why would I need to go through the trials and tribulations of implementing a laboratory quality management system?

Implementing a laboratory quality management system does not guarantee you won’t have any issues in the future. Still, it’s a platform to allow you to foresee potential errors and give you the tools to prevent them from occurring.

It is tremendously valuable that laboratory results are accurate, reliable, and delivered on time in healthcare.

To achieve the highest performance, we need to execute all processes at the highest level. That’s where laboratory quality management can help us.

What are the 12 essential elements of a quality management system?

1. Organization
2. Personnel
3. Equipment
4. Purchasing and inventory
5. Process Control
6. Information Management
7. Documents and Records
8. Occurrence Management
9. Assessment
10. Process Improvement
11. Customer Service
12. Facilities and Safety

Organization

Commitment from management is crucial to ensure we deliver value.

The leadership team must engage with all employees to create a clear communication structure that allows concerns to be raised without repercussions.

One of the things that I hear a lot from leadership is that everyone wants to please them, and nobody wants to give them the bad news.

This is the result of years and years of old school management. It is more important than ever to show our teams we care for them and respect them, especially when it’s our role to lead highly qualified people in a laboratory.

Personnel

People want more than ever to follow leaders who care for them.

When recruiting people, we need to ensure they are qualified for the role and ensure they have a set of soft skills that allows them to fit in the culture.

I would rather recruit somebody slightly less qualified but with higher emotional intelligence.

You can always teach technical skills, which lay the path for training and development that so many people crave, but changing someone’s behavior or approach is complicated.

I am not necessarily saying you should change people, but we need to define our values and recruit accordingly to ensure a good culture.

Inclusive culture with the correct values will keep your personnel engaged and ensure your laboratory performs.

You can have the best equipment and the best facilities in the world, but without the right people, you won’t achieve much.

Equipment

I touched upon this in the previous block. Equipment is crucial for our team to do their job accordingly.

When purchasing new equipment, we must ensure it’s fit for purpose, verified, maintained, and so on…

The equipment must be calibrated at the specified intervals to ensure the data collected is meaningful or the process is executed at the correct parameters.

It’s advantageous to have a team of people working together to achieve all these steps. 

People specialize in different things. That way, you can delegate tasks accordingly and ensure all stakeholders receive what they need.

Imagine we have some samples in a fridge, and for some reason, it goes down. While catastrophic failures are a thing, we must ensure we have assessed all the potential risks and contingency plans are in place for situations like this.

Equipment needs to work for us and not the other way around.

Purchasing and Inventory

To run a laboratory, we will need different chemicals and reagents.

All materials must come from reputable and regulated sources. It is not the time to compromise to reduce costs.

The purchasing role is not only to buy materials to keep the lab going but to evaluate suppliers and contracts to ensure we get the most value out of the supply chain.

Purchasing can audit suppliers to ensure they comply with international standards like ISO or evaluate potential risks related to the products sourced.

At the same time, they must negotiate contracts to get the best possible rates.

Planning is another crucial function; it’s no good if we run out of materials while performing critical analysis.

Material requirements planning is a must to ensure a smooth operation.

Process control

This is where we establish the quality control procedures.

Many companies have inspectors evaluating parts at specified intervals to ensure everything is working as expected in manufacturing.

In the laboratory, it’s our role to specify clear procedures to ensure samples are managed correctly and follow all the specified steps.

Validating and verifying these procedures is the role of the supervisors or leaders in our team.

Quality control is crucial in any organization, it might feel like an unnecessary requirement, but intervention at the right time can prevent us from catastrophic failures.

Information management

We live in a world where big corporations use data to target specific individuals for certain things.

For the reason described above, confidentiality is more and more critical. It’s our role to protect our customers or patients and prevent them from discrimination, so they feel safe in our hands.

We might require different levels of access to specific information depending on the type of testing we are conducting. We might opt to serialize patient details, so it’s only available to them.

Documents

I have talked about the importance of processes and procedures previously. If we need to add new documents to keep up to date, how do we ensure we communicate the changes to our team?

Our laboratory quality management system must ensure creating, revising, implementing, and distributing documents is done safely.

People need to be working on the latest revision of a procedure, and we must ensure things like training records are also up to date.

We also need to be careful not to overload the system with bureaucracy. Simplicity is key to ensuring a smooth operation.

Occurrence management

Dealing with customer complaints or issues the quality control team picks up is also part of the job.

We must ensure we have clear procedures to analyze complaints, so we can escalate issues as required or use them as lessons learned to prevent them in the future.

If we find an issue with a sample, we need to put a corrective action to minimize the impact on other specimens until the problem is thoroughly analyzed and we understand its root cause.

Root cause analysis is critical to implementing clear preventative actions that ensure issues don’t occur again in the future.

Laboratory assessment

It’s not within the scope of this article to talk about how we can be ISO accredited or compliant with CLSI (Clinical Laboratory and Standards Institute). Still, if we are planning to get accredited, we will get an inspector looking at our overall operation at some point.

Auditing our processes and systems regardless of inspections can help us identify gaps and propose improvements.

It is mandatory to have an internal audit program in ISO. Ensuring our team can assess internal processes and procedures will be beneficial regardless of the requirement.

Process improvement

The continuous improvement cycle allows companies to stay relevant in the current market.

Revising our processes and procedures is mandatory if we want to reduce costs or improve efficiencies.

Process improvement can come from an internal audit assessment, or it could be due to stakeholder feedback.

It could also come from a customer complaint or a risk assessment.

The source is not what matters. What matters is that we take action and we strive to improve.

Customer service

To deliver quality, we must understand our customer’s requirements and needs.

We must listen to what they want and ensure we meet their expectations. That’s what quality is all about.

We must listen to the good, the bad, and the ugly and take notes. For example, if a report is not clear, we must ensure the technical jargon is simplified so a patient can understand it.

Customer feedback needs to be a part of our continuous improvement cycle.

Facilities and safety

Depending on the type of laboratory we have, we might deal with abrasive chemical reagents that could harm our employees.

Risk assessments need to inform management of the different risks our employees might be exposed to when working for us.

We must ensure our employees leave work healthy and can carry out the everyday tasks of their role.

We also need to evaluate the facilities to ensure the environment is appropriate for the type of testing or work required.

Ergonomics also plays a critical role in ensuring the safety of our employees.

Conclusion

The introduction of a laboratory quality management system can be tedious, so I have summarized the twelve essentials below:

1. Organization: The leadership team must create a clear communication path with its employees.
2. Personnel: Our team must be motivated, and we need to ensure they can perform their job correctly.
3. Equipment: We need to provide our team with the necessary tools to carry their job out.
4. Purchasing and Inventory: We must evaluate our suppliers and ensure they can deliver what we expect.
5. Process control: We need to ensure we place the proper inspection criteria to catch issues before reaching our customers.
6. Information management: We need to protect the privacy of our customers and ensure confidentiality.
7. Documents and records: Our employees must work to the latest revision of a procedure, and the system needs to reflect that.
8. Occurrence management: In the unfortunate event of receiving complaints, we must ensure there is a platform to correct issues and learn from them.
9. Assessment: We need to look at our processes and procedures to check for gaps in our systems.
10. Process improvement: We must strive to improve continuously. It’s the only way to stay relevant in the market.
11. Customer service: We need to listen to customers and create experiences that make them want to return to us.
12. Facilities and safety: We must ensure our employees work in a safe environment

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