Internal Audit

Internal Audit Checklist for Laboratory

Before proceeding to understand how the internal audit of laboratories is done, I am sure that the importance of laboratory testing is already understood by the world at large, owing to the recent outbreak of COVID-19 across the world. Though there are many controversies relating to how the virus was spread, you get the idea that if proper testing is not done in the laboratory, it can very well result in mass destruction of the population at large.

Controlling something that one is able to see and witness is easy, but when we specifically come to medical laboratories, we cannot see or directly feel the bacteria. Hence, if any spread of dangerous bacteria is done, it is nearly impossible for the human race to take control of the same. We, the human race, have been the witness of the corona spread across the world and its implications. We are living in a time when we are reaching the moon, but at the same time, it has become nearly impossible for us to control one virus. Hence, the importance of laboratory audits is very apparent. We will now know how this type of audit is conducted.

There are two principles on which the laboratories are based. They either perform analysis or tests in some organizations, or they work as a third party to perform tests on the samples provided by the clients or customers. A laboratory audit is an assessment which is performed in order to demonstrate whether the laboratory’s operations are as per the accreditation regulations, like ISO 15189 and ISO 17025. The detection is also made if there are any deviations in the processes that might affect the quality of the system in the operations of the pharmaceutical companies.

Audits Goal for Laboratories

The aim is to check the conformity of the laboratories with ISO 9001. If the laboratory has not maintained process documentation, the auditor will use the general standard requirements of ISO 9001 in order to review the process as in clause 8. The investigation should also be done to confirm that the records provide evidence and the process meets the requirements.

Types of Laboratories

There are six types of laboratories, as defined below-

1. Medical or Clinical Laboratory
2. Research & Development Laboratory (R&D)
3. Chemistry Laboratory
4. Biosafety Laboratory
5. Biological Laboratory
6. Physics Laboratory

Medical or Clinical laboratories-

A medical laboratory refers to the place where medical professionals or doctors perform tests on the samples received from the patients so as to assist them with the information relating to their health. It is commonly found in clinics, hospitals and pharmaceutical companies.

Research and development (R&D) laboratories-

These laboratories are unfairly characterized as outdated. It provides the backbone for many companies and also provides support to all departments, which is visible in modern-day research operations in industries like pharmaceuticals and technology.

Chemistry laboratory-

It is one of the most useful laboratories that exists. It is also used to create substances that do not usually occur in nature, to purify the substances that already exist or extracted from something through processes like distillation with boiling point between 315 -heretical-300 Kelvin.

The production of chemicals takes place both legally and illegally, meaning that it has potentially harmful side effects on humans when incorrectly handled. The amount of the use of solvents should also be tracked down so that no mishandling takes place due to the lack of safety protocols.

Biosafety Laboratories-

Scientists use biosafety laboratories to study contagious materials more effectively. These facilities are designed not only for the protection of the researchers but also to prevent microorganisms from entering the environment. The focus is on working with viruses and bacteria; it can be classified as ML-I, ML-II and so on.

Biological Laboratory-

It is a type of science which is often studied in the laboratory. Research in bio labs is conducted on bacteria, fungi, etc. One more type of bio lab is botany, where the test is conducted on plant varieties. The research is different in different countries. For instance, in the Netherlands, bio labs are used to figure out how to grow crops in a better way.

Physics Laboratory-

It is more than a place for scientists to do their experiments. Investigation in physics laboratories is also done pertaining to how objects behave under pressure.

Steps to conduct the test

There are certain steps that are followed in order to conduct proper analysis and test, as given below-

1. To receive the test samples
2. The classification of the test samples
3. The preparation stage for testing includes apparatus preparation, conditioning, etc.
4. To perform the test analysis
5. To generate the test reports

In order to perform these basic operations, there are many factors that should be taken care of in order to give effective test results. It can include the documentation of the test procedures, the competence of personnel who are performing the tests, testing equipment fitness, the environment where the test is to be performed, checking whether the test results are traceable or not, etc.

Laboratory Audit Checklist

There are a few constituents mentioned below that should be incorporated into an ISO 9001 Laboratory audit checklist:

• The risks and opportunities associated with the laboratories
• The aims and objectives of the laboratory
• Requirements of the resources and the provision to perform laboratory operations
• The competence of the persons who are performing the tests
• Fitness records of the testing equipment
• The documents which are maintained for laboratory processes
• The criteria for collecting the samples, the information which is retained and the samples classification and the identification of the samples
• The information which is retained to give desired test results
• The non-conforming test results control

Types of Laboratory Audits

There are mainly two types of laboratory audits, namely external laboratory audits and internal laboratory audits.

1.     External Laboratory Audits

These types of audits are conducted by third-party agencies outside the laboratories. Their main aim is to get the certification or accreditation in order to enable the laboratory to operate in the relevant markets. There are certain requirements, and If the laboratory offers testing services for a medical device company and is planning to start its business in EU member countries, in that case, it must invite the accreditation first. If the accreditation is received, then only the company would be allowed to start the business and not otherwise.

2.   Internal Laboratory Audits

This type of audit, as the name itself suggests, is performed by the members of the same laboratory who are working in different departments. The purpose of internal audits is to perform a quick assessment of the quality practices of the laboratory. It is basically a preparation for conducting external audits, and it also identifies any critical non-conformity which might create severe consequences during the conduct of external audits.

Auditor Qualifications

The NABL, which is the National Accreditation Board for Testing and Calibration Laboratories, prescribes certain qualifications to hire the expert for NABL as mentioned below-

Age	Educational Qualification	Experience
The expert shall be of 38-55 years of age.	Bachelor’s degree in Technology/Engineering or Master’s degree in Science For Medical testing purposes, a Ph.D. in scientific fields or post-graduation is required.	10 years of experience in Calibration/testing, out of which five years should have been spent in supervising activities. For Medical Testing: 10 years of experience in a clinical laboratory, out of which 5 years of experience in a supervisory role. For RMP and PTP: 10 years of experience is required in analysis and training as per the ISO 15189 or ISO/IEC 17025

Some additional skills might include good communication skills, both oral and written. Handled responsibilities for day-to-day testing. Publication of research papers on testing and calibration is a plus, too.

Areas to examine

There are specific areas where the audit is necessary. The areas include but are not limited to:-

Previous Audit Finding

It means to conduct the audits based on the previous audits that were conducted. It is conducted to check whether the laboratory has implemented enough CAPA (Corrective and preventive Actions) to remove past errors and non-compliances or not.

Processes and Operating Procedures

The auditors also check whether the process is carried out as per the quality principles or not. For instance, Standard Operating Procedures (SOPs) are very important for the execution of all the processes in the laboratory. The auditors can also investigate whether the laboratory processes follow the approved SOPs or not.

Competence of the Staff & Training

The recruited staff of the laboratory must be competent enough to understand the requirements of the laboratory environment. The laboratory is responsible for keeping the staff up to date about the laboratory practices, the latest processes and the regulatory requirements. A training plan can also be put in place for the staff working in the laboratory. This plan can include the topics of training, the schedule of the training, training material, etc. This plan is created in advance for the whole year, and it is approved before the start of staff training.

Equipment

Equipment occupies a crucial space in the laboratory industry. Equipment must be in proper working condition and their usage shall not exceed the equipment’s standard operating specifications. Equipment calibration and routine maintenance are also important. An equipment log can be developed too, which indicates the usage, and it is filled out every time the test is performed by the staff. One more example can be the calibration records and certificates. The originals must be obtained from the calibration performing agency. One must be able to present all the necessary calibration records during the time of audit.

Environmental Conditions

The environmental conditions are very crucial for performing the work and the test. The environment should be such that it should not prevent sample deterioration. The log containing information relating to the humidity, temperature and other environmental parameters must be carefully maintained.

Key to Laboratory Safety Checklist:-

What are the steps to ensure that the Laboratory is audit-ready?

In order to make sure that the laboratory is audited-ready, the employees of the laboratory must align with the prevailing rules and regulations of the country so that no auditor can issue warnings or non-compliance to the laboratory. Unannounced audits are also conducted sometimes, which means conducting an audit without informing the laboratory. Below are some of the steps to ensure that no non-compliance is done on the part of the laboratory-

• To follow the Equipment Maintenance Plan- All the documents should be completed, such as the maintenance checklist along with signatures, etc.
• To conduct Equipment Calibration activities regularly- The regulatory bodies mostly inspect calibration activities, which is why it occupies one of the most critical parameters. It is used to check the precision and accuracy of the equipment while performing measurements. The records should be maintained properly with the relevant approvals and signatures. All the tasks relating to calibration can be performed easily by using the equipment management module, which is built into SimplerQMS. It helps in sending email notifications when the task or calibration activity is due and also assigns them to relevant personnel.
• To check that the SOPs are up to date or not- SOPs refer to the Standard Operating Procedures. SOPs are to be updated whenever new equipment is installed, or any new process has come into place which is to be implemented. The staff of the laboratory must follow the standard operating procedures in all of their routine operations.
• Staff Training Facilitation– The staff of the laboratory must be competent so that mishandling can be avoided. They must be proficient in carrying out day-to-day activities like sample handling and safety principles. The management of the laboratory is also responsible for conducting training programs. SimplerQMS is software worth it because it allows one to handle all functions effectively, from planning the training to execution.

• To facilitate the Validation Process– To ensure that the validation activities are completed with relevant documents. Examples include- Operational Qualification, Performance Qualification, Installation Qualification etc. The chart below shows the essentials of the validation process-

• To implement a highly secure database system- The data of the laboratory must be secured from any kind of hacking or breaching. The user levels must be created with password protection. It should also include backups, audit trails, etc. In laboratory audits, time plays a crucial role. The auditors must have the relevant data available to them on time. Software like SimplerQMS provides time-stamped audit trails, document versioning, secure Azure cloud storage, etc.

Laws relating to Laboratory testing in India

We all are aware that India is the fourth largest country worldwide, having the highest number of SARS-CoV-2 cases. It was the case despite conducting 119 tests per million people. Whereas in countries like Russia and the United States, 1518 and 2074 tests were conducted per million population. The rates of testing were also insufficient in India because of the legal scenario that regulates medical testing.

The private labs in India are regulated under the Clinical Establishments Act of 2010. These labs have been functioning under self-imposed and market-led norms. But, during the spread of the coronavirus in the second phase, the Indian government had to grant discretionary power to ICMR for regulating the testing strategy. 

The labs have to comply with the State Shops and Establishments Act, which relates to working hours, holidays, etc. They also have to obtain registration under the Biomedical Waste Management Rules of 2016. The reagents and diagnostic kits used by the labs are explained under the head ‘drugs’ under the Drugs and Cosmetic Act of 1940. It has to be approved by the CDSCO (Central Drugs Standard Control Organization). The NABL (National Accreditation Board for Testing and Calibration Laboratories), which is an autonomous body, prescribes the criteria for different types of labs. In India, out of all the labs that exist, nearly 4,000 labs have NABL accreditation.

The purpose of accreditation is to assure the quality of labs; therefore, in order to ensure better quality testing, some reputed laboratories prefer obtaining certifications from International Accreditation bodies in addition to NABL accreditation.

Conclusion

Hence, the need for laboratory audits is clearly there. First, we have to make sure that the environment we live in is safer for us and our families. For instance, the laboratories that investigate the plants do this so as to make sure that we inhale fresh air. This type of audit also ensures that the environment we live in is free of bacteria and viruses that may be harmful to our bodies. However, we still lack proper audits in this area, as witnessed during the time of the coronavirus outbreak. However, after the COVID-19 case, the services of laboratories have been made better owing to the disaster that the coronavirus brought to the world.

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