The Ultimate Lab Audit Guide

What is a lab audit, why is it important, and who needs to be concerned? 

Laboratory Environment, Health and Safety (EHS) audits are not just about checking boxes; they are systematic evaluations to ensure minimal impacts from environmental aspects and health & safety hazards. Simply put, the purpose of a laboratory EHS audit is to assess the compliance of laboratory operations, systems and processes against EHS regulatory requirements, company requirements, standards, and best practices. Audits identify opportunities for improvement and the laboratory undergoing the audit should develop corrective and preventive actions (CAPAs) to address the gaps.   

B. Importance of Compliance

EHS compliance isn’t just a regulatory obligation – it’s a commitment to operate legally, protect workers, and preserve the environment.  Non-compliance with EHS regulations could result in:

• Uncontrolled risks that harm employees or the environment;  
• Violations resulting in regulatory enforcement; 
• Fines and penalties; and
• Reputational damage.

A laboratory audit checklist is more than a checklist; it serves as a structured tool to guide auditors through the complexities of an EHS assessment. It helps auditors strategically and comprehensively assess a laboratory's EHS practices. Checklists can be considered an auditor’s best friend because they help you maintain consistency during audits and provide a documentation trail.  

Laboratory EHS audit checklists can be used by company EHS employees, Quality personnel (where EHS is a component of a quality audit), EHS auditors who are responsible for conducting or overseeing laboratory audits, and laboratory managers. These checklists aim to equip you with a framework for conducting successful EHS audits and are beneficial for organizations across various industries. 

How to Prepare for a Lab Audit

A. Understanding Regulatory Requirements

1. Overview of Relevant Regulations: Familiarize yourself with EHS regulations pertinent to your laboratory's activities. This may include requirements from government agencies, accreditation bodies, or other organizations. 
2. Updates and Changes in Regulations: Keep an eye out for new EHS regulations or revisions in regulations to ensure your laboratory remains in compliance. Subscribe to regulator newsletters or legal register services, join industry networking groups, or review industry publications for this information.

1. Determine the Type of Audit: What is the purpose of this EHS audit? Is it an internal self-assessment, an external audit requested by a certification body, or a regulatory compliance audit announced by a local authority? Understand the purpose of the audit. 
2. Specific Areas of Focus: Define the scope and boundaries of the audit. Identify the physical areas and processes you intend to assess. Examples of programs that may be included are hazard communication, calibration/maintenance, industrial hygiene, air and water quality, hazardous waste management, etc. 

1. Past Audit Reports: Review previous audit reports to identify recurring issues and areas needing attention. This will help you follow up by addressing known weaknesses.
2. Standard Operating Procedures (SOPs), Records, and Documentation: Request EHS SOPs, records and documentation. Get all the necessary documentation readily available so the audit runs smoothly and efficiently.
   
   

How to Create a Customized Laboratory Audit Checklist

1. Categories and Subcategories: A well-structured checklist will make it easy to use and navigate. Create categories and subcategories that represent the EHS topics that must be focused on. Picture these as the chapters or overarching categories in your EHS audit book – environmental management, occupational health and safety, hazardous material handling, and emergency response. 
2. Question Format: Develop questions that are objective and concise. These questions are intended to get people talking about how they do their job so be clear with your wording. Each question should be formatted in a way to elicit a straightforward response.

1. EHS Management System Gaps: Identify systemic gaps in EHS management that may affect multiple processes. For example, a deficiency in Management of Change processes means insufficient management of the decommissioning of a lab. Another example would be excluding non-managerial employees from a Safety Committee when they should be included to voice their EHS concerns and promote worker consultation and participation.  
2. Environmental Impacts: Assess the different pathways the environment can be impacted: air, water, waste generation, and energy usage. 
3. Workplace Safety: The safety of the employees should be the top priority. Evaluate the risk assessment process to ensure that workplace hazards are recognized and controlled. Ensure all contractors and employees are protected within operational controls. 
4. Equipment and Instrumentation: Look for EHS critical laboratory equipment and instrumentation (e.g., fume hoods, biosafety cabinets, gas monitoring systems). Evaluate the monitoring and measuring practices such as calibration and maintenance.
5. Personnel and Training: Take note of the qualifications and training requirements of laboratory employees. Verify that staff have the training and competencies for their roles.

1. Mapping Checklist to Regulations: Customize the checklist so that it aligns with the local regulations applicable to your laboratory. Each item on the checklist should correspond to a regulation, company requirement, or best practice if there is no requirement.
2. Customization for Audit Scope: Modify the checklist to reflect the areas of focus determined during audit scoping. For example, if the audit is focused on a specific area of the laboratory's operations, the checklist should focus on that area specifically.

1. Involving Lab Staff: Plan out a schedule of interviews and lab walkthroughs with the lab managers. The goal is to avoid unnecessary disruption of their work so don’t show up unannounced.  
2. Seeking Input from Subject Matter Experts: EHS team members or consultants can help you in developing your checklist. They may be the auditors, or they may have a supportive role. Leverage their expertise so you can prepare for challenges that will arise.   

How to Use a Laboratory Audit Checklist

1. Familiarizing Audit Team with the Checklist: Ensure that the audit team has reviewed the checklist's structure and content. This includes understanding the associated programs, questions, and the rationale behind them (i.e., regulatory or company driven, or best practice).
2. Assigning Roles and Responsibilities: Define the roles and responsibilities of each audit team member. Who is taking the lead on different sections? Who is doing a walk-through of specific areas? Who is documenting the interview notes? 
3. Finalize Audit Schedule: Set up interview invites ahead of time so the lab managers and employees can plan for your arrival. 

1. Step-by-Step Audit Process: Conduct the audit systematically as best as you can. The schedule may not go according to plan so be prepared for on-the-fly contingencies. In no particular order, review documents and records, ask questions, and observe operations as necessary. You may have to rinse and repeat those steps.  
2. Documenting Findings: Record all audit findings, observations, and deviations from compliance. Document all findings, both positive and negative.

1. Analyzing Audit Results: Review the audit findings and identify trends or recurring issues. Determine the severity of non-compliance according to the company audit manual or other standard.
2. Corrective and Preventive Actions (CAPAs): Develop a plan for the laboratory to address non-compliances, including development of CAPAs to address immediate concerns and recurring issues in the future. CAPAs should include responsible parties, actions to take, and clear deadlines.  
3. Continuous Improvement: Use the audit results to drive opportunities for improvement (OFI). Implement engineering and administrative controls, update documentation, consider EHS Management System changes, and conduct training to address the issues. Engage leadership periodically and keep them up to date on CAPAs and other initiatives that require attention. 
   
   

Tips for a Successful Laboratory Audit

Communicate clearly and concisely with lab employees and auditors. Establish open lines of communication early in the audit process. This will help everyone stay on the same page and ensure that questions or concerns can be addressed promptly. Be respectful of the time and expertise of the lab employees and auditors. 

Ensure that you and your audit team have a good understanding of the regulations, company standards, audit checklist, laboratory operations, and any laboratory requirements prior to arriving on site. 

Conduct the audit in a professional and respectful manner, mindful of the laboratory's employees and operations. Minimize disruption and remember the goal of the audit is to improve the lab’s compliance with regulations and standards, not to find fault. 

C. Templates and Software for Checklist Creation

There are various software tools and templates to develop a laboratory audit checklist. Some options include Microsoft Excel templates, Microsoft Forms, Google Forms, and other audit management software.

Final Thoughts on Laboratory Audits

A comprehensive laboratory audit checklist is a critical tool for ensuring that a laboratory meets all applicable regulatory and company requirements, maintains high standards of quality, and is continuously striving to improve its EHS and quality performance.

B. Encouragement for Continuous Improvement and Compliance

Laboratory audits are essential assessments for laboratories to drive continuous improvement. There is no perfect laboratory when it comes to EHS or Quality but by maintaining an audit program, laboratories can set themselves on a path of excellence to mitigate risks to as low as reasonably achievable.

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Resources

1. Links to Relevant Regulatory Bodies

• ISO 14001
• ISO 45001 
• Good Laboratory Practice (GLP)
• OSHA
• EPA
• FDA

1. Recommended Reading Materials

• "Laboratory Auditing for Quality and Regulatory Compliance" by Donald Singer, Raluca-Ioana Stefan, and Jacobus Staden 
• “Environmental Health and Safety Audits” by Lawrence Cahill