Tips to Perform Your Next Laboratory Quality Audit

Tips to Perform Your Next Laboratory Quality Audit

March 26th, 2013 // 3:03 am @

March 26, 2013

It is always strongly advised that a laboratory conduct its very own internal quality audit every few months to make sure that test analyses always provide reliable results. By doing an internal audit, you also will provide your lab with detailed knowledge of how well it follows its own quality guidelines, and you will be prepared for audits by your clients and possibly FDA.

April 3 – How to Audit Your Lab Like an FDAer

Data that is produced by laboratories is used to make all types of strategic decisions for many drug projects, including investigation, remediation and compliance. It is very important that your data is of the very highest quality to avoid budget overruns and expensive resampling. A good laboratory audit makes sure that the lab has high quality systems in operation and that it follows the best lab practices. It also makes sure that the lab produced data with both quality and integrity.

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As you are preparing for your quality audit, remember that how successful it is depends upon strong preparation, precision in performance, well documented reports and efficient follow up. Essential preparation steps include these:

  1. State what the purpose of the audit. A quality audit is usually performed to determine the effectiveness of lab programs that are made to provide maximum quality to the customer. The scope of the audit and the technical processes involved will determine what resources you need for your quality audit of your lab.
  2. Determine what the scope of the lab audit is. You need to set the limits or boundaries of the audit. Is this audit going to be across the organization, just the central lab or a satellite lab? Will you cover all analytical methodologies or just a specific subject? What will the impact be of the audit scope on your lab personnel and operations?
  3. Figure out what audit team resources are going to be used. That is, determine what special knowledge and skills are needed for each team member to handle the audit scope.
  4. Who is the authority for this audit? Typically, the authority for the audit will come from the company, the quality assurance manual or the request of a third party.
  5. Determine what the performance standards will be. A quality system in a lab has a great many shapes, names and pieces. So, the auditing team has to evaluate the quality system against a set standard. This doesn’t mean that all quality systems in labs are the same. The big challenge is to ensure that however your quality system is set up, all necessary functions are covered in the audit.
  6. Develop a strong technical grasp of all of the processes to be audited. The audit team functions better if it has a very good grasp of the quality system of the lab. It is a good idea to study the quality manual and implement procedures and information from previous audits.
  7. You then need to contact all of those who are going to be audited. The lead auditor needs to ensure that it is done properly. The first contact will provide a good rapport with those being audited and to fully work out audit logistics.
  8. Do an initial evaluation of lower tier documents to the high level requirements. This is a process that is part of the education process for the auditing team.
  9. You then need to develop written checklists of all data needs. The audit program may be used to cover several similar laboratories, so some of the checklists may be somewhat generic. The main function of such checklists is to collect data, so the specific issues that are to be examined will be listed. The audit question also has to be directly tied to the standard that originally established the requirement. This technique will give protection from the checklist just being the auditor’s wish list.

For many more helpful lab audit tips, consider attending our April 3 webinar, How to Audit Your Lab Like an FDAer.


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