“It is strongly recommended that a laboratory conduct its own internal quality audit with sufficient frequency to assure that test analyses provide continuously reliable results. An internal audit will also provide the lab with knowledge of how well it follows its own quality program and prepare it for audients by clients.” Guidelines for Laboratory Quality Auditing, Donald C. Singer and Ronald P. Upton
Data generated by laboratories are used to make strategic decisions for all types of projects (investigation, remediation, compliance, etc.). It is important that the data are of the highest quality to avoid costly resampling and budget overruns. A laboratory audit ensures that the laboratory has quality systems in place, follows good laboratory practices, and generates data of integrity and quality.
The success of the audit is based on adequate preparation, precise performance, well documented and insightful reporting, and productive follow-up.
HOW TO PREPARE:
- Define the purpose of the audit. Quality audits are performed to analyze the effectiveness and implementation of programs designed to maximize the quality of goods or services delivered to the customer. The scope and technical processes involved lead to determining the needed audit team resources.
- Define the scope of the audit. The scope of the laboratory quality audit is defined as to limits or boundaries. Will the scope be corporate/organization-wide; the central laboratory; or a satellite laboratory? Will all analytical methodologies or a specific subset be covered? What impact will the audit scope have on the laboratory personnel and operations?
- Determine the audit team resources to be used. Determine what special skills/knowledge is needed among the team members to efficiently and effectively handle the scope of the audit.
- Identify the authority for the audit. The authority for the audit comes from the company/organization quality assurance manual, the contract for the analytical services or the request for the third party audit.
- Identify the performance standards to be used. The laboratory quality system has as many shapes, pieces and names for the pieces as there are authors. As a result, the audit team must evaluate the auditee’s quality system against a standard. This does not mean that all laboratory quality systems are identical or should be. The challenge is to make sure that however the auditee’s quality system is named and described; all the necessary functions are covered and implemented. The audit team will correlate the auditee’s system against the auditor’s system for equivalency of coverage.
- Develop a technical understanding of the processes to be audited. The audit team will function more effectively and efficiently if it has a good understanding of the laboratory’s quality system. Studying the Quality Manual and implementing procedures and historical information from prior audits (if available) prior to reaching the laboratory provides the mechanism to focus on the “mission critical” issues and develop better checklists.
- Contact those to be audited. The auditee is informed of the audit by the mechanism appropriate for the situation. The Lead Auditor needs to make sure it is done or do it, as the situation dictates. This initial contact provides the opportunity to establish rapport with the auditee, to work out the logistics of the audit and to acquire documents necessary for preparation, if not already available. The formal audit plan is transmitted to the auditee upon its approval.
- Perform an initial evaluation of lower-tier documents to higher-level requirements. This process is part of the education of the audit team. The process also provides much of the focus for the actual on-site data gathering efforts.
- Develop written checklists of the data needs. The focus developed in the preceding section is documented in the development of the checklists. Where the audit program is used to cover multiple comparable laboratories, some parts of the checklists are generic. Since the main function of the checklist is to gather data, the specific issues to be examined are listed. The audit question must also be directly linked to the standard that established the requirement. This technique provides protection from the checklist being an auditor’s “wish list”. Checklists are reviewed or approved (generally by the Lead Auditor).
*The above information is based on a presentation given at the ACS Central Regional Meeting, June, 2001.
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