System/Performance Audits

Our QA department staff performs a host of internal system and performance audits to ensure that data quality objectives are met. In addition, our laboratory undergoes routine inspections by external auditors. These internal and external audits encompass:

• Good laboratory practices (glp)
• Training procedures and records
• General record keeping
• Document control
• Data storage and retrieval
• Sample storage and chain-of-custody (COC) procedures
• SOP compliance
• Reagent storage and control

Standards preparation and traceability Data audits Good automated laboratory practices (GALPs) Performance evaluation samples The QA department summarizes results of all audits and reports these to laboratory management. Corrective actions are taken when necessary and such actions are carefully documented.

System audits are performed both by internal and external auditors. Clients and federal and state certifying agencies perform external system audits. A system audit is performed to qualitatively assess the laboratory's control systems and is intended to provide evidence of the laboratory's competence.

The objectives of a system audit include ensuring that:

• management is committed to creating a work environment dedicated to quality and that a structured management system is in place to support an effective QA program,
• the QA program is documented and implemented to assess work to ensure technical, administrative, and quality objectives,
• personnel are adequately trained and qualified to do their jobs, procured items and services meet established requirements and perform adequately,
• procedures are established and maintained for the timely preparation, issuance, control, and revision of documents, including documentation of review and approval, and that records are specified, prepared, reviewed, approved, and maintained for evidentiary purposes,
• computer hardware meets requirements and that any changes are controlled; computer software is developed, validated, verified, and documented; and that any changes are controlled
• work performed complies with established technical standards and administrative controls, as well as safety policies, and
• procedures are established for detecting and preventing quality problems and for ensuring quality improvement.

Out-of-Control Events during QA, Management, or External Audits

During various internal or external audits, an out-of-control event might be observed that can adversely affect laboratory quality on a more global basis. These events might affect, for example, entire analytical systems; projects; data usability or integrity; or sample integrity and security, or personnel safety. An unacceptable result on a performance evaluation (PE) study or internal blind PE study can also be an indication of a systematic problem. Other examples include:

• temperature excursions on successive days in a sample storage refrigerator
• improperly calibrated analytical equipment
• poor spike recoveries on multiple extractions of a laboratory control sample
• contaminated glassware or sample/standard storage
• inaccurate/incomplete SOP or personnel not following SOP
• deviations in COC documentation or procedure
• obliterations, writeovers, or other improper data corrections
• expired standards on the "active" shelf of a refrigerator
• open or unlabeled waste containers
• inadequate hood velocity

These out-of-control events and the corrective action taken to resolve them are documented in several ways, such as: An interoffice memorandum is written to the responsible party describing the out-of-control event and requiring a written response including corrective action by a specified date. After internal or external audits, a formal report is written to all involved laboratory areas that describes any non-conformances or deficiencies found. Written responses must detail corrective actions taken. For external audits, these responses are included in the formal written response to the auditor.

A Corrective Action Report form is completed when an external or internal client identifies a deficiency. This form documents what the out-of-control situation is, who is responsible for correcting the problem, what action is to be taken, and the target date for implementation. The form is used to enter information into a tracking database.
The nonconformance is closed once QA or lab management has determined that implementation is complete and that system control is restored. Reports are kept on file. Corrective action will be initiated as a result of performance or system audits, split samples, or data audits.

Acceptance limits for CLP methods are published in the Statement-of-Work (SOW). Limits for non-CLP methods or limits that are not specified in the method are subject to change based on updated intra-laboratory statistical performance data. Generally, acceptance criteria are advisory unless the client requires specific corrective action steps for failures.