Women Working in a Laboratory Environment

Laboratory Quality Management System (QMS)

by | Nov 23, 2021 | QMS

Laboratory Quality Management System (LQMS) is a standardized procedure and practice contributing to the overall quality of laboratory test results.

According to LQMS, the quality of a testing result does not depend on a single step. But instead, it requires quality in individual processes, resources, and overall organizational structure.

For example, an essential element of Laboratory QMS is an Internal Audit. The organization’s employees perform the internal audit as a way of self-assessment.

It identifies gaps or non-compliances (NCs) and suggests corrective actions to eliminate undesirable situations. As a result, internal audits help increase the overall efficiency and reliability of the test procedure and its result.

In this article we will discuss:

What Is a Quality Management System in a Medical Laboratory?

Quality Management System in the medical laboratory requires quality in all steps. The test results must be accurate and reliable, and reports must be produced on time without tampering.

Laboratory functions that require quality practices include:

  • Environment
  • Quality procedures
  • Record keeping
  • Expert human resource
  • Quality reagents
  • Quality equipment and instruments

For example, a Sensor in a Stability Chamber records the humidity levels for a product. If the sensor becomes faulty, the laboratory is responsible for investigating the root cause. The laboratory is also responsible for taking preventive actions to prevent the recurrence of the problem.

Worth noting that the Quality Management System (QMS) in a laboratory environment is different from an Electronic Quality Management System (eQMS) or quality management software, QMS software for short. An eQMS is a software solution for implementing QMS principles following the requirements from standardization bodies such as the ISO and FDA.

In a medical laboratory environment, an Electronic Quality Management System (eQMS) can assist Laboratory Quality Management System (LQMS) functions such as Record Keeping, CAPA Management, Document Control, and more.

Standards Governing Laboratory Quality Management System (QMS)

The Laboratory QMS is an ISO standard adopted by its all member countries.

There are two applicable ISO standards – ISO 15189 and ISO 17025.

Note that the ISO does not perform accreditation activities. Instead, it develops different relevant standards. Third parties mandated by the ISO carry out accreditation.

ISO 15189 – Medical laboratories — Quality and Competence

The ISO 15189 ensures quality in medical laboratories. Its current version is 2012 and is indicated as ISO 15189:2012.

This standard guides the development of the laboratory’s quality management system, technical solutions, and administrative sections that are the main factor for a laboratory’s functioning. Any laboratory, regardless of test or assessment, can use this standard.

The technical committee for this standard is ISO/TC 212 – Clinical laboratory testing, and in vitro diagnostic test systems. The ISO plans to replace this standard with ISO/DIS 15189, which is currently under-development stage.

ISO 17025 – Testing and Calibration Laboratories

ISO 17025 standard is developed for laboratories that perform calibration and testing. It enables the calibration performing laboratory to prove accuracy in results.

This helps increase customer trust around the world, harmony among all laboratories, and eliminates the need for further testing.

12 Essentials of Laboratory Quality Management

The framework of the Laboratory Quality Management System (LQMS) is divided into 12 quality system essentials. The Clinical and Laboratory Standards Institute (CLSI) develops these principles.

These quality principles act as an individual building block for an effective laboratory QMS. If one of them is overlooked, LQMS cannot be successful and can fail eventually.

12 Laboratory Quality Management System (QMS) Essentials

Following is the description of each quality principle, and details on how an efficient QMS software for medical laboratories can help you follow these principles seamlessly.

Organization

Illustration of an Organization Structure

The organization is defined as the management’s role and commitment in implementing Laboratory Quality Management System (LQMS). The management must support the Laboratory QMS and establish ways to highlight its importance to the staff. The laboratory’s design approval and functioning must have recognized legal status from a local regulatory body.

Key organizational components defined under this quality principle include:

  • Leadership – leader’s commitment to implementing LQMS by team building, motivational, and communication skills.
  • Organizational structure – an organization’s structure must be clearly defined, indicated by an organizational chart.
  • Planning process – management should plan for skill development.
  • Implementation – management should address any issues in implementing LQMS.
  • Monitoring – monitoring systems for ensuring LQMS design according to standards. Monitoring is also necessary for Continuous Improvement.

For example, management must provide a Job Description(JD) to every staff. JD should indicate their role, responsibility, who are their subordinates, and to whom they report. Suppose there is any change in organizational structure, such as in the case of employee promotion. In that case, the concerned person should update the Job Description with information to all relevant organizational functions.

An eQMS can help you implement organization-level quality principles without the need for separate software for every process. It connects the laboratory head, such as the manager, to all necessary processes, procedures, documents, and records – such as Job Descriptions and Training Certificates. With its cloud storage capabilities, documents can easily be accessed from any device, the only requirement being an internet connection.

Personnel

Personnel within a laboratory environment

Personnel is a critical quality principle they are the ones implementing and following Quality Management System (QMS) in a laboratory. The personnel must be responsible, knowledgeable, understand the importance of quality, and be willing to be a part of continuous improvement.

The Laboratory Director is responsible for developing correct Job Descriptions and hiring appropriate staff. He is responsible for training, competency assessments, and annual employee performance appraisals. He is also responsible for staff’s continual education to update the personnel with the latest technologies and trends.

All employees must go through a performance appraisal. This is an advanced stage of competency assessment and includes more detailed evaluation such as adherence to policies, observance of safety rules, communication skills, punctuality, and behavior.

The laboratory should keep employee records regarding their lab work, which becomes essential when calculating their benefits. The employee record must be in a safe place and remain confidential. Records, unimportant for laboratory function, may be kept with other centralized departments such as the Human Resource.

For example, seminars or exhibitions provide an excellent way of keeping employees updated with the latest technologies. After the visit, the participants may submit a report about the visit consisting of knowledge gained, the relevancy of the visit, and suggestions for further improvement if necessary.

An eQMS with robust training management capabilities like SimplerQMS helps you automate the training activities and it can contain employee records (with GDPR compliance). It can efficiently handle all functions from planning training to execution. It tracks when training is due and distributes the training material. It automatically sends a notification when new trainable material is released. At the end of the training, it generates a certificate of training with an electronic signature.

Equipment

Illustration of Equipment Calibration Analysis

Proper functioning equipment can have many advantages, such as increased performance, increased confidence, and reliability in results. It also lowers repair costs and increases service life.

Efficient equipment management can be achieved by the following:

  • Selection and purchasing – the purchased equipment must be according to laboratory requirements.
  • Installation – equipment must be installed according to requirements.
  • Equipment calibration – system for performing medical test equipment calibration processes must be in place.
  • Maintenance and troubleshooting – preventive maintenance must be made part of maintenance. It requires developing maintenance plans and following the plan accordingly.
  • Validation – the department should perform equipment validation before the equipment goes into operation.

A technologist in a laboratory can be responsible for all the equipment in a laboratory. Commonly, a technical person competent in troubleshooting and maintenance is made accountable. They oversee all the equipment activities and functions.

The laboratory must maintain a logbook regularly detailing all the vital information about equipment. For instance, a logbook can include information such as the test performed, the person performing the test, and more.

For this process, you can also consider using an eQMS with built-in calibration management features to streamline your calibration activities and ensure compliance with the regulatory body requirements. It keeps track of calibration data and automatically triggers notification before calibration becomes due. Furthermore, it allows you to assign the responsibility of calibration to appropriate persons and provides a log to be used during regulatory audits.

Purchasing and Inventory

man pushing trolley with supplies

Adequate inventory of components such as reagents is crucial for reliable and satisfactory laboratory performance. If there is an unavailability of any item, it can delay the testing process.

Proper purchasing and inventory principles ensure sure that inventory is available when required, operations are efficient and cost-effective.

A reliable purchasing and inventory management must fulfill the following requirements:

  • Supplier Qualification
  • Purchase agreements
  • All received materials must be inspected for accurate specifications. The received materials must be stored as per recommended requirements, to avoid waste or change in their specifications.
  • Tracking the items to their final destination
  • Maintaining Inventory
  • Controlling expiration date
  • Dispatching items, if there are any satellite laboratories

A successful purchasing and inventory management system in a Laboratory Quality Management System (LQMS) can be successfully implemented by the following steps:

  • Assigning responsibility
  • Evaluating Laboratory Needs
  • Developing Minimum stock requirements
  • Developing and using electronic forms and logs
  • Digital System for receiving, inspecting, and storing received materials

For example, the use of certain chemicals is prohibited by the general public and is only allowed to be used by licensed drug manufacturers or laboratories. They must justify their stock levels against usage to the local drug regulatory authorities. For this purpose, logs and forms are highly important and help in averting penalties from the regulatory bodies.

SimplerQMS supplier management software module helps you automate your vendor selection process by evaluating and qualifying the vendor against different performance criteria. It maintains the list of approved suppliers, as well as provides forms for record-keeping of contracts, surveys, certificates, and supplier evaluation. It also notifies the relevant persons, in due time before a supplier needs to be re-qualified.

Process Control

Illustration of Process Control

The main driver of laboratory success and satisfactory performance is how well the laboratory can handle and control all processes. One of these processes, critical to laboratory performance is sample management.

The sample collected must be standardized and represents the actual condition. As soon as the sample is collected, it must be stored with recommended storage conditions to prevent damage.

Accurate sample management starts with good sample collection practices.

This practice must be in written form and include the following:

  • Information required on the sample collection form
  • How to handle urgent requests
  • Sample collection, and Labelling
  • Preservation and transport
  • Safety practices such as in case of leaked or broken containers
  • Evaluating, and Processing samples
  • Storage
  • Disposal

They must be accurately labeled to avoid sample mix. The label should contain critical information such as Sample Identification, Collection data, time, tests required, etc. If not correctly labeled, the chances are that sample will undergo the wrong test, leading to erroneous results.

SimplerQMS allows laboratory managers to generate sample recognition labels. The label information is customizable and can be easily tailored to individual laboratory requirements. The titles are traceable to original samples and prevent misuse or interchange with other samples.

Information Management

Document and lock indicating Secure Information Management

The information management principle focuses on the accuracy, security, confidentiality, and privacy of a patient. The final product of a laboratory is data, which often contains critical information about the patient that they do not want to disclose.

Some elements of the information management principle include:

  • Unique identifiers – for patients and samples, every time patient utilizes the service, the same identifier is used. Similarly, a unique identifier is generated for every sample collected.
  • Standardized test request forms – for necessary information collection when requesting a test.
  • Logs and worksheets – for recording sample data at the arrival of the laboratory.
  • Checking processes – to assure the accuracy of data recording and transmission
  • Data protection against loss
  • Protection of patient confidentiality and privacy
  • Effective reporting systems
  • Effective and timely communication

You can efficiently utilize the form management module by SimplerQMS to streamline Information Management processes in your laboratory. SimplerQMS provides you with various pre-defined forms, and you can use them, for example, for patient information, log, and lab results. SimplerQMS also allows you to retrieve data by different data points such as Name or Patient Number and track historical reports and trends. All records are kept in an encrypted and secure vault, which conforms with the requirements of HIPAA and GDPR.

Documents and Records

Documents and Records in laboratory environment

These quality principles focus on laboratory documents and records. The required information must be available when desired.

They must be updated every time a policy, process, or procedure changes. Standardized forms and formats must be used for recording information.

Examples of documents include quality manuals, standard operating procedures, work instructions, and others. Specific documents common to work processes should be accessible to specific personnel based on their job role.

With an automated document control software solution, you can collect data with precision. It enables the automatic generation of documents on approved formats with necessary approvals. It also ensures that only the current and updated version of documents is always available. Such software solutions provide access to documents from a single system and prevent manual record-keeping in all critical departments.

Occurrence Management

Illustration of an Audit Trails

Occurrence management focuses on continual improvement.

An occurrence is an action or event that can harm the staff in a laboratory, performance, equipment, or environment. It identifies errors or near misses in testing or communication and devises necessary steps to prevent these errors from reoccurring.

When occurrences are found, they must be investigated for the root cause. This prevents recurrence in the future. After occurrences are detected, they can be rectified by taking appropriate Corrective and Preventive Actions (CAPAs).

The laboratory should maintain a proper system for occurrence management, including the following:

  • Establishing a process to detect problems
  • Log of all problems, and respective investigative and remedial actions
  • Investigating cause
  • Necessary action
  • Prevent recurrence by monitoring the original problem
  • Knowledge sharing to all who need it and those affected

For example, for a given sample, the result failed to pass the test. Although, before the trial, all pre-analytic indicators were satisfactory, so it was assumed that the results would also be satisfactory.

The laboratory decided to cross-check and gave the test to another person, which passed the sample test. The investigation revealed that the reagent used by the first person was expired, and he failed to identify the expiry date. To prevent the recurrence of this problem, the first person was trained for reagent identification, and performance was evaluated for satisfactory working.

Non-conformance management is an essential part of every laboratory and it generates a high number of documents.

Software such as SimplerQMS and its non-conformance management module can provide an efficient digital solution to these problems. It automatically notifies the concerned person when nonconformance tasks are assigned to them. It helps in generating CAPAs and helps track the progress. It allows you to monitor incomplete and overdue CAPA and overview the nonconformances (NC) by-product, process, component, customer, equipment, supplier, or other data points through customizable dashboards.

Assessment

Illustration of Documentation Assessment with a magnifying glass

Assessment is an integral quality principle that evaluates all the functions of a laboratory quality management system (LQMS) and demonstrates that it is meeting regulatory and customer requirements.

International Organization for Standardization (ISO) uses the audit instead of assessment.

There are two types of audit – internal and external.

The laboratory’s internal people perform internal audits. People working in one area perform an audit of another area. The primary purpose of conducting an internal audit is to identify any potential weaknesses.

On the other hand, external audits are carried out by external professionals and experts in their relevant fields, and significant purposes include accreditation, certification, or licensure.

For example, personnel involved in sample testing can perform an internal audit of the sample collection procedure. They can assess different stages of sample collection, such as label quality, transportation, and sample storage.

SimplerQMS can help you reduce the time and effort needed to pass audits successfully. It allows you to link a response or CAPA to the audit findings. Digital audit management solution automates data collection, routing, notifications, and approvals and stores all data in centralized, cloud-based storage which allows you to conduct remote audits seamlessly. The system also automates task assignments to individual persons and tracks their progress against their due date.

Process Improvement

Illustration of Continuous Process Improvement

Process Improvement is continual improvement, requiring continual efforts in improving processes.

According to ISO 15189, the continual improvement process should:

  • Identify potential sources of any system weakness or error
  • Develop plans to implement improvement
  • Implement the plan
  • Review the effectiveness of the action
  • Adjust the action plan and modify the system following the review and audit results

Some techniques useful for process improvement include internal and external audits, external quality assessment, and management review of all data gathered. The output of these tools is the opportunities for improvements (OFIs), providing the basis for the corrective action. Some new tools, Lean and Six Sigma, have also been included together with the traditional tools.

For example, Corrective and Preventive Action (CAPA) is successfully used in various industries, which provides a systematic approach to track down corrective actions and their success. Traditionally CAPAs are generated manually and require personnel involvement. This sometimes causes a delay in initiating CAPA and in-complete CAPA. This process can easily be improved by deploying an automated CAPA system.

CAPA management software provides an opportunity for automating the CAPA process. You can automatically collect data, route, follow-up, notifications, approvals, and escalate overdue activities to make all CAPA in line with regulatory body requirements. SimplerQMS limits the manual intervention and helps in streamlining missing documents. It also prevents chasing signatures and avoids manual circulation of document copies.

Customer Service

Customer Reviews

Customer service is a crucial quality principle and forms the basis of developing a quality management system in a laboratory environment. There can be many customers for the laboratory, including patients, physicians, public health agencies, and communities.

The laboratory head is responsible for ensuring and measuring the degree of customer satisfaction. Different mediums can be used to measure satisfaction, such as surveys, indicators, and audits.

Customer feedback systems can be deployed for every customer. Such a solution would allow real-time data gathering about the satisfaction level.

The complaint management solution by SimplerQMS allows you to track, manage, analyze and resolve complaints, all in a single system. The software automatically notifies the right person or department on time and provides an insight into feedback data, which can be effectively used to improve your products and increase customer satisfaction.

Facilities and Safety

Manufacturing Facility with a truck

This quality principle focuses on the safety of laboratory staff and the quality of work.

Lack of attention to this principle can lead to negative consequences such as:

  • Loss of reputation
  • Loss of customers
  • Low staff retention
  • Increased costs related to human resource

Laboratory Safety and quality are the responsibility of the laboratory head. He/she must actively participate in lab designing, assess all potential risks, and provide feedback on developing a safe laboratory.

To ensure safety and quality of work, there must be an adequate supply of safety equipment such as:

  • Personal protective equipment (PPE)
  • Fire extinguishers
  • Appropriate storage for flammable and toxic chemicals
  • Eye washers, and emergency showers
  • Waste disposal supplies and equipment
  • First aid equipment

A waste management system must be responsible for the safe disposal of waste, particularly harmful contaminated waste.

For example, a regular evacuation drill can be helpful in case of a real fire. It allows the laboratory head to evaluate the safety routes, the safety kit, and the lab staff also become informed of emergency practices.

The Importance of Quality Management Software in Laboratory Environment

Nowadays, drug manufacturing and testing laboratories are starting to use software-based Quality Management Systems for easier compliance and streamlined quality processes. While the user is not bound to any specific software provider, basic provisions are mandatory to fulfill.

One essential and basic requirement for medical laboratories is to follow 12 quality essentials. If a lab fails to integrate these principles, it can lead to significant non-compliances.

The laboratory QMS software is not a requirement by ISO nor by any regular body. However, such a software solution can make quality processes much more accessible to implement, which is difficult to implement in traditional paper-based or manual systems.

SimplerQMS is cloud-based quality management software, which means you are not bound to a specific workstation. The system is designed specifically for life science organizations and includes proper security features. SimplerQMS software solution allows you to work more efficiently with your documentation and helps ensure compliance with ISO 15189, ISO 17025, the FDA, and GxP guidelines.

Final Thoughts

There is an increasing trend in software applications in the manufacturing industry, causing an industrial revolution.

Examples of such software solutions include Computerized Maintenance Management System (CMMS) and Warehouse Maintenance System (WMS). These software solutions provide the industry owner with an opportunity to increase their production efficiency with improved quality while at the same time lowering cost and delivery times.

The regulatory and standardization bodies have also enhanced their standard specifications to deal with this industrial revolution, making their standards more focused and updated towards quality.

The QMS software like SimpleQMS enables the laboratories to keep their operations in line with different regulatory and standardization requirements. Such software automates routine QMS operations like notification generation, task assignment, and others, relieving the humans for more critical tasks. Together with cloud-based storage, QMS has become agile without the need of maintaining manual documentation.

To see how the SimplerQMS solution can help you work more efficiently with your documentation, we recommend you book a personalized demo and talk to our experts.

eQMS Business Case Template

Illustration of eQMS Business Case Template