For researchers working in a regulated laboratory environment, preparing for a lab audit can be a daunting task. This is especially true if your records, staff training and SOPs have been neglected for a long period of time. Trying to play “catch up” once you learn about an impending lab audit will almost always be a losing proposition.
Once you learn about an upcoming laboratory audit, it will help to first understand the scope and depth of what will be reviewed. This will help you prepare your materials and allocate time and resources. However, the best way to prepare for a lab audit is to always be ready for an audit. Implementing sample management software with sample tracking and audit log features is the easiest way of being prepared for an audit of your laboratory.
What information is needed in a lab audit?
Audits help ensure your lab is complying with government and organization regulations and policies and will look at information like:
- Operating procedures
- Equipment calibration and maintenance records
- Staff policy and procedural training and adherence
- Environmental safety standards
Standard operating procedures (SOP)
While reviewing your SOPs, ask:
- Are your SOPs up-to-date with your lab’s latest regulations, processes and equipment?
- Is it easy for staff to access SOPs and track their progress through the established workflow?
- Are there any regular situations or routines not covered by your SOPs?
Check your equipment for signs of wear, and ask questions like:
- Are your calibration records and certificates up-to-date and available for the audit?
- Is your equipment operating correctly and safely?
- Has maintenance like freezer defrosts occurred regularly?
When looking at how well lab staff follow the rules and operating procedures of the labs, ask these questions:
- Does your lab hold regular staff training sessions? Is it well attended?
- Do all staff know what to do in case of emergency?
- Are there any safety or security standards being bypassed for convenience (or other reasons like needed access)?
- Is all information getting correctly recorded in a timely manner?
- Are your lab’s security standards being upheld?
Ask yourself and other staff questions like:
- Are workers under undue strain or at risk from the environment?
- Are there underlit areas or heavy items stored up high?
- Are fire exits adequately marked and pathways free of obstruction?
- Are potentially hazardous materials correctly stored and disposed of?
- Are all required security measures being enforced and followed?
- Is Personal Protective Equipment being used correctly and available every time it is needed?
Tips to remain ready for a lab audit:
- Make sure your Standard Operating Procedures are up-to-date.
In order to understand how your lab is processing samples or collecting data, the auditor will be looking for clear SOPs that accurately describe the work in the lab. In general, once SOPs are created, they should be reviewed each year by people doing the work – and edited and versioned appropriately. Keeping your SOPs accessible and accurate will make preparing for an audit less stressful. If you have created corresponding lab workflows, you should also make sure that these accurately reflect your documented procedures.
- Ensure staff training records are up-to-date, complete and easily accessible. Auditors will check that the staff performing work in the lab are competently trained in the work they are performing. Keep accurate records of staff training and make sure that staff are getting regular refreshers as lab processes are updated.
- Have audit-ready sample records.
This can be challenging if your lab doesn’t follow standard procedures for record-keeping, or if your sample management software isn’t already doing this for you. If you’re not sure if your sample management system keeps audit-ready records, start by asking yourself- “If I picked a sample at random, would I be able to identify everything that happened to this sample?” Follow the “Who/What/When” approach – who performed that on what sample when? Sometimes the answer may be yes, but it could be a jumble of assorted records spread between notebooks and electronic systems. If you can’t establish the chain of custody easily and quickly, it may be time to reconsider your sample management system.
LabKey Sample Manager makes complete sample records and chain-of-custody easy to access with our Timeline feature. Timeline shows the complete chain of events for an individual sample from initial registration, to metadata/status updates, all storage events, related assay data and addition of samples to a workflow job.
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