Regulatory bodies such as the ISO and the FDA frequently evaluate laboratory operations to check compliance. Because laboratories guarantee quality in medical device and pharmaceutical companies’ operations, any non-conformance in the laboratory can mean non-conformance in entire company operations.
For example, during their audit, regulatory bodies can check to see whether laboratory testing records are genuine or have been altered. If they find any dubious records, they can issue a warning.
This article introduces you to typical laboratory audits and various types. It also gives you some valuable tips that will help you in succeeding in your external audit and discusses the advantages of using digital audit management tools.
But first, let’s go through the basics:
- What is a Laboratory Audit?
- What Does a Laboratory Audit Examine?
- Tips to Ensure Your Laboratory Is Audit-Ready
- How to Perform an Internal Laboratory Audit
- How Often Are Laboratories Audited?
- Laboratory Audit Management Software Solution
What is a Laboratory Audit?
A laboratory audit is an assessment performed to demonstrate that the laboratory’s operations are according to regulatory standards and accreditation regulations, such as ISO 15189 and ISO 17025. It also detects any deviation in their processes that could affect the quality system in medical device and pharmaceutical company operations.
There are two types of laboratory audits – external and internal audits.
External Laboratory Audits
Third-party agencies perform external audits outside of laboratories. Their main purpose is to get accreditation or certification so that the laboratory can operate in the relevant markets. If the inspection bodies observe that the laboratory has established a laboratory quality management system (QMS) according to applicable requirements, the auditors recommend the accreditation to the laboratory.
For example, if a laboratory offering testing services for a medical device company plans to start its business in EU member countries, it must first invite the relevant accreditation and regulatory bodies for inspection. If it gives accreditation, the company is allowed to start its business. Otherwise, it cannot.
Internal Laboratory Audits
Internal audit is performed by employees or staff of the same laboratory but in different departments. The main purpose of an internal audit is to perform a quick assessment of the laboratory’s current quality practices.
It is an effective way to prepare for external audits and identifies any critical non-conformity that could create severe consequences at the time of external audits.
What Does a Laboratory Audit Examine?
The audit is carried out to assure the organization’s compliance with the requirements and law. If the auditors find any non-compliance, it could result in a warning or operation suspension.
Here are some examples of areas that an auditing body might be interested in:
- Previous Audit Findings
- Processes and Operating Procedures
- Staff Competence and Training
- Environmental Conditions
Let’s discuss each one in more detail.
Previous Audit Finding
Sometimes, the audit is conducted based on past audit findings.
It is conducted to observe whether the laboratory has to implement enough corrective and preventive actions (CAPAs) to remove the non-conformities identified by previous auditors.
Processes and Operating Procedures
The auditors check whether the process is carried out are according to quality principles.
For example, Standard Operating Procedures (SOPs) are necessary for executing every process in the laboratory. The auditors could check whether laboratory processes follow the approved SOPs or not.
Staff Competence and Training
The laboratory staff should be competent to understand the necessities and requirements of a laboratory environment. The laboratory is responsible for its staff training to keep them updated about laboratory practices, current quality principles, latest processes, and regulatory requirements.
For example, a training plan should be devised for all the staff working in a laboratory. The training plan should include training topics, training schedule, training material, and who will conduct training. The training plan is created for the whole year and is approved before starting staff training.
All equipment should be in proper working condition, and its usage should not exceed the equipment’s standard operating specifications.
Routine maintenance is also necessary, including equipment calibration.
For example, an equipment log must be developed indicating its usage and filled out every time a staff performs the test. Another example could be calibration records and certificates. Their original must be obtained from the calibration performing agency and made part of the laboratory records. You must be able to present necessary calibrations records at the time of an audit.
The environmental conditions must be adequate for performing the work and performing tests. The laboratory environment should prevent sample deterioration and the environment should not affect the tests being performed.
For example, a log containing values of environmental parameters such as Temperature and Humidity must be properly documented, maintained, and presented at the time of an audit.
Tips to Ensure Your Laboratory Is Audit-Ready
External auditors typically inform laboratories before conducting audits. However, it is not unusual to conduct an audit without prior information, these are called unannounced audits.
In any case, it is in the laboratory’s benefit to always remain audit-ready so that external auditors cannot issue any major warning or non-compliance to the laboratory.
Secondly, if the laboratory remains audit-ready, it builds credibility to the external auditors if they decide to conduct an unannounced audit without prior information.
Let’s discuss some tips that can help your laboratory remain audit-ready instead of leaving your audit preparation to chance.
1. Conduct Regular Equipment Calibration Activities
As mentioned before, calibration is one of the critical parameters that regulatory bodies inspect. Calibration indicates equipment’s accuracy and preciseness in performing measurements. The equipment should be calibrated with a regular calibration plan, and proper records should be maintained with relevant approvals and signatures.
All the above-mentioned tasks related to calibration can be easily handled using QMS software such as SimplerQMS. It allows you to manage documentation for each piece of equipment, create tasks and assign them to relevant personnel, and send email notifications when the calibration activity becomes due.
2. Follow a Regular Equipment Maintenance Plan
Regular equipment maintenance is one of the most effective ways to tackle the audit team.
Thus, you need to prepare a preventive maintenance plan and strictly stick to it. After each preventive maintenance, complete all the documents, such as the maintenance checklist with proper authorization and signatures.
3. Facilitate Staff Training
Inspectors inspect whether the staff working in the department is capable enough to carry out day-to-day routine activities such as safety principles, sample handling, and other activities. Laboratory management is responsible for conducting training programs.
Using QMS software such as SimplerQMS to automate training is a worthwhile investment in this regard, as it allows you to efficiently handle all functions from planning training to execution.
It allows you to easily schedule employee training by their respective designation and role. It tracks when training is due, distributes the needed training material, and sends notifications when new trainable material is released. Finally, at the end of the training, it generates a certificate of training with an electronic signature.
4. Ensure Standard Operating Procedures (SOPs) Are Up to Date
Ensure that SOPs are updated every time a new process is implemented, or new equipment is installed.
Similarly, laboratory staff should follow all the SOPs in their routine operations.
5. Facilitate Validation Processes
Ensure all the validation activities are completed with relevant documentation.
For example, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) should be executed before using newly installed equipment.
6. Implement a Secure Database System
Lab data systems must be secure and withstand any hacking or breaching attempts. Appropriate user levels must be created with password protection. Additionally, it should include audit trails, backups, disaster recovery, as well as 21 CFR Part 11 compliant electronic signatures.
Furthermore, an essential aspect of audits is the timely availability of the relevant data to the auditors. Otherwise, it can pose serious consequences to the laboratory.
A QMS software like SimplerQMS can provide various solutions for the aforementioned issues.
Some of the solutions that SimplerQMS provides are time-stamped audit trails, document versioning, 21 CFR Part 11 and GxP compliant electronic signatures, centralized repository, linking of documents, secure Microsoft Azure cloud storage, and more.
7. Perform Regular Internal Audits
Regular internal audits are also beneficial in preparing laboratories for external audits.
It helps in pinpointing any shortcomings that could result in severe warnings or non-conformances.
How to Perform an Internal Laboratory Audit
As mentioned previously, an internal audit provides an opportunity for the laboratories to assess their own shortcomings, and most importantly, it is also a compliance requirement.
Let’s look at the necessary steps that are critical to a successful and compliant internal audit.
The scope identifies the area of interest for the audit team and is used to define the limits.
For example, is the audit team auditing any process or a laboratory standard?
2. Audit Checklist
Checklists are critical points or processes that auditors intend to audit. Commonly, they are reference guidelines by regulatory bodies to which the laboratory is accredited.
For example, if the auditors are inspecting calibration procedures for a laboratory, the checklist would include the relevant processes from the ISO/IEC 17025 – general requirements for the competence of testing and calibration laboratories.
3. Team Selection
As mentioned above, an internal audit is carried out by the staff of the same laboratory. Therefore staff working in other departments or sections should be selected for conducting an audit to avoid conflict of interest.
For example, if the auditors inspect the sampling department, staff working in the testing department can be selected in the audit team.
Create a schedule for conducting an audit and provide information to the relevant department so that they can make arrangements and prepare.
For example, a schedule can include allocating the first half of the day for auditing the processes, personnel, and equipment. The second half of the day could be dedicated to auditing documentation and the final meeting.
Start audit by the initial meeting with the departmental representatives, including a brief introduction with the audit teams, their roles, and responsibilities.
After the introduction, start collecting and analyzing information. The audit should remain within its scope and should not exceed it.
Conclude audit with the final meeting, and share results with the departmental staff.
6. Audit Report
After completing the audit, generate a detailed audit report. In the audit report, provide details of non-conformities with the evidence and recommend an improvement for rectifying the non- conformities.
Lastly, you will need to present the audit report to the management to implement the recommendation and improvement.
7. Laboratory Record
As mentioned above, the internal audit is a regulatory requirement.
So for presenting to the inspectors of regulatory bodies, ensure you make the internal audit report part of your laboratory records and be ready to present it during an external laboratory audit.
How Often Are Laboratories Audited?
External audits are initially conducted when a laboratory seeks accreditation with the relevant regulators or standardization bodies. After the initial audit, these accreditation bodies periodically conduct inspections to make sure their arrangements are regular and do not deviate from their guidelines.
It is necessary to conduct an internal audit once a year.
However, this does not mean that all processes or functions should be inspected in a single audit. Small sections or procedures can be individually audited anytime in a year, but an internal audit for a whole laboratory must be completed once a year.
Overall audit completion time depends on the laboratory size and functions. Small size laboratory audits can be concluded in just one day, whereas audits for large-scale laboratories can take days.
Laboratory Audit Management Software Solution
The manual paper-based system always poses a difficult situation during the audit, no matter how well papers are arranged and personnel deployed for handling documentation. Unavailability of required documents, version miss-match between control and department copy, and documents without signatures or approvals are one of many serious problems. In addition, manual documentation requires days to prepare for the audits.
Investing in the audit management software from SimplerQMS relieves you from collecting, sorting, and arranging documents. It provides you with a centralized repository of all your documents so that you can easily access them. The documents are stored in the cloud and can be accessed from every location with a network-compatible computing device.
All the laboratories must prepare for audits. It results in quality processes, customer trust, and increased revenue for the laboratory.
Today’s laboratories are burdened with strict regulatory requirements and increasing costs.
Adopting the latest technology helps laboratories tactically face the auditor’s requirements, including audit management software by SimplerQMS. It allows you to focus more on planning rather than worrying about arrangements.
If you are interested in learning more about how SimplerQMS can help you streamline your audit-related activities and help you pass audits successfully, we recommend you book a personalized demo and talk to our experts.