When out-of-control events occur, they are documented and corrective action is implemented. Corrective action is the process of identifying, recommending, approving, and implementing measures to counter unacceptable procedures, deviations from laboratory standard practices and procedures, or out of control quality control (QC) performance that can affect data quality. To the extent possible, samples are reported only if all QC measures are acceptable. If a QC measure is found to be out of control, and the data are to be reported, all samples associated with the failed QC measure are reported with the appropriate data qualifiers. How such events are documented depends on the type of event and area where the excursion occurred. Most out-of-control events identified during routine sample processing are restricted to single samples, batches, or data reports. Some examples of these types of events include:
- incorrect client identifier on chain-of-custody (COC) documents
- improper or broken sample containers
- unpreserved or improperly preserved samples
- lab accident during sample processing
- accuracy failures for surrogate and/or spike standards
- precision failures between duplicates
- variations in internal standard responses
- contamination of method blank
- missed holding time
- errors or omissions in data reports
Corrective action may occur prior to, during and after initial analysis. Corrective actions are performed prior to release of the data from the laboratory. The corrective action is addressed in the SDG Narrative by the case reviewer and on the analytical worksheets, signed by the analyst and reviewed by the supervisor. The types of excursions that occur and the corrective action documentation that results during different stages of sample processing are discussed in the following sections.
Corrective Action Types
CompuChem has two separate corrective action policies that are in effect and are initiated, depending on the item requiring corrective action. As a result of external and internal system audits or external and internal data audits, identified defects, findings, and even observations will result in the generation of a Corrective Action Report (CAR) by a representative of the QA department. The CAR identifies the deficiency and is generally sent to the supervisor of the appropriate area. It also may specify the action step needing to be taken. A turnaround time requirement is specified and the CAR is returned to the QA department for approval. CAR documentation is maintained in the QA department and is available to external auditors.
Sample-specific corrective actions are addressed in the laboratory Standard Operating Procedure (SOP) collection. Sample-specific corrective actions include repeats due to unacceptable surrogate recoveries, internal standards not meeting acceptance criteria, dilution re-injection requirements, etc. These types of corrective actions do not require CAR documentation. For certain occurrences, laboratory notices are prepared and are included in the SDG Narrative section of the deliverable package, as well as discussed in the narrative itself. Most of these notices are prepared after discussions with a QA department representative. They do identify the event and address the corrective action. The Case Reviewer is responsible for assessing them and addressing all sample-specific corrective actions in the report narrative. Case Reviewers are the most senior members of the technical staff and are given the authority to approve laboratory notices as the laboratory managers' designee.
When project issues are brought to our attention, the appropriate Project Manager is usually first contacted. They complete a Client Inquiry form and take it to the personnel responsible for addressing the issue. Sometimes, a CAR will be initiated based on the concern. The policies are further discussed below.