A Quick Guide to Laboratory Audits: What Are They, Ways to Prepare, and How to Use Them to Your Advantage

What is a laboratory audit?

Laboratory audits are thorough and comprehensive evaluations of a laboratory to ensure that it is operating in compliance with regulatory and accreditation standards. ^{1^2} These audits guarantee that a laboratory’s facilities, processes and systems are meeting industry standards. Audits can either be external, conducted by third party agencies such as the US Department of Agriculture (USDA) or by a prospective customer, or they can be internal, conducted by a different department of the same company.¹ Often, the internal audits are performed as a means of preparing for external audits and to ensure ongoing compliance to required standards.¹ Either way, audits are not to be taken lightly, because noncompliance can result in various negative consequences such as operation suspension or a damaged organizational reputation.

How to make sure your laboratory is prepared for its next audit

Audits are meant to capture an authentic snapshot of the day to day operations of a functioning laboratory, thus they are often conducted without warning. In anticipation of future lab audits, here are some ways to prepare:

• Ensure proper staff training
  • In particular, when new employees come on board, but also regularly for existing employees as well; it is important that staff is trained properly and regularly refreshed on the lab’s protocols and procedures.
• Review Standard Operating Procedures (SOPs)¹
  • Ensure that SOPs are always kept up to date, especially when new equipment or processes are introduced.¹ Require a review of any new or updated SOP prior to implementation to ensure that it communicates clearly the needs and expectations related to the procedure.
• Perform internal audits and create an internal compliance program³
  • Regular internal audits are an invaluable tool. They allow labs to reflect inwardly on internal operations and to determine where there may be shortcomings and how to correct them. Doing so helps a lab maintain constant readiness in case an external auditor comes unannounced.^1,3
  • Creating an internal compliance program that is updated regularly based on new regulations or laws establishes accountability.³
• Embrace quality and compliance as a key component within the business
  • The culture of the company is as important as the individual checks conducted within an audit. Auditors will look not only at their criteria, but they will also look at the demonstrated behaviors and messaging. A company that fully embraces quality is easily recognized.
• Identify responsible persons and empower everyone
  • It is important for a business to have responsible persons whose role is to ensure that they have oversight on all relevant quality and control processes to ensure clear communication, appropriate training is provided etc., and who can provide guidance to the business.
  • It is equally as important to ensure that everyone has quality embedded into their individual role. Quality is not the responsibility of one individual but of the organization and as such everyone needs to understand the expectations and take ownership for success.

Applying these internal processes will not only improve your readiness for an audit but will increase the overall quality of your service offering and make you more attractive to customers, resulting in increased revenue. Quality is never negotiable with a customer, and the most successful companies embrace it as a key pillar of their strategy.

How a VERIF.i® pre-assessment can increase access to clients and prepare you for audits

Are you a contract research organization (CRO) trying to differentiate your services from those of your competitors? Do you provide in vivo services, human biological samples and/or CMC related services? If yes, then our VERIF.i® pre-assessment program could be the key to unlocking new clients and increasing revenue.

Working with top industry pharma, we have developed a pre-assessment program in these areas. The intent of VERIF.i® is to enable a supplier to proactively demonstrate that their policies, procedures and processes meet the requirements of potential and existing clients, that clients can trust them with their research prior to work being placed.

When conducting pre-assessments directly with a client, suppliers often face some common challenges:

• Expensive
• Resource intensive
• Time consuming

To combat these challenges, our VERIF.i® pre-assessment program allows you to share an independent assessment to your entire customer base, enabling them to proactively evaluate your organization, thereby reducing the number of pre-assessments and preparing you for potential study-specific audits that may occur during the life cycle of a project.

For more information on VERIF.i® please visit our VERIF.i® info page or contact compliance@scientist.com.

References

• FROLOVS, G. [February 2022]. Laboratory Audits: Overview, Guide, and Tips[online]. Available from: https://www.simplerqms.com/laboratory-audits/ [Accessed June 2022].
• [June 2009] 9 Steps on How to Perform a Laboratory Quality Audit[online] Available from: https://www.labmanager.com/business-management/9-steps-on-how-to-perform-a-laboratory-quality-audit-20371 [Accessed June 2022]
• OBERHEIDEN, N. https://www.hg.org/legal-articles/medical-lab-audits-5-keys-to-a-strong-defense-61435 [online]. Available from: https://www.hg.org/legal-articles/medical-lab-audits-5-keys-to-a-strong-defense-61435 [Accessed June 2022].
• TREW, D. [2015]. Top 10 Tips When Preparing for a Laboratory Audit [online]. Available from: https://learngxp.com/good-validation-practices/top-10-tips-when-preparing-for-a-laboratory-audit/ [Accessed June 2022].