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12.0 PERFORMANCE AND SYSTEMS AUDITS
1. Internal systems audits are conducted by company personnel in response to unacceptable or questionable QC or sample data and is a review and evaluation of the various components of the measurement and sample collection procedures to determine their proper selection and use. It should consist of a detailed review of each component (such as decontamination, meter and sampler calibration, field measurements, matrix sampling, Quality Control measures, documentation, sample custody, etc.)
a. Systems audits should be conducted at least annually.
b. Usually, these audits are conducted by the Quality Assurance Officer or his or her designee.
c. A determination should be made that each element of an activity is functioning appropriately and within the guidelines of the proper methodology, the approved procedures and QA Plan.
d. A list of deficiencies that must be addressed to correct, improve and modify the system must be generated as an end result.
2. Internal performance audits on field activities are not required by DER. If utilized, they should be documented as to the supplier of the sample, the type of sample used, and results should be included in all internal or external QA reports.]]
1. External systems audits may be conducted by outside organizations. THE ADOPTION OF THIS SOP IS CONSIDERED TO BE A STATEMENT OF SUBMISSION TO ON-SITE DER AUDITS.
2. External performance audits should document the type of performance sample used in the audit and results should be included in all internal or external QA reports.
12.1.3 Project Audits - Data Validation by DER
Project-specific audits are conducted at the request of the DER project manager or when the project has been conducted without meeting the proper QA requirements. These audits consist of a complete review of the pertinent data, ancillary records and method validation packages.
12.2 REQUIREMENTS FOR AUDITS OF LABORATORY OPERATIONS
12.2.1.1 Obligations for External Audits by DER
All parties are subject to facility, and data audits conducted by authorized representatives of DER. THE LABORATORY SHALL SUBMIT TO ANY SUCH AUDITS THAT HAVE BEEN REQUESTED BY DER OFFICIALS.
The DER audits may be a systems project or performance audit and will be conducted to determine compliance with the associated CompQAPs or QAPPs, Chapter 17-160, F.A.C., or other Department requirements (i.e., permits, consent orders, etc.).
12.2.1.2 Documentation and Reporting Requirements
In addition to DER audits, the laboratory may be subject to audits from other outside sources (e.g., EPA, HRS, etc.). All external audits shall be documented:
a. Record the date and organization conducting all external system audits.
b. Record the date and type of all external performance evaluations conducted by outside auditing parties.
c. Summaries of all external audits shall be included in QA Reports to DER (see Section 13.0).
[[12.2.2.1 Internal Systems Audit
Internal systems audits should be conducted as the complement to implementation and use of internal SOPs and Quality Plans, in order to assure good Quality Assurance management practices.
In general, procedures for conducting internal audits should be developed according to the following guidelines:
a. Schedule systems audits to occur with routine frequency. Annual auditing of all lab operations is a minimum recommendation. Audits of selected systems may be staggered throughout the year to accomplish this goal.
b. Develop a standardized protocol and list of minimum requirements which will constitute the style and scope of the audit and which will provide the criteria list by which operational deficiencies can be detected. These protocols and criteria should reflect the intent of all internal SOPs and Quality Plans, and should at a minimum conform to all DER regulatory requirements for procedures and documentation. The use of standardized audit forms and checklists is recommended.
c. Designate appropriate personnel as Quality Assurance staff and charge these officials with auditing responsibility and authority, preferably independently of and lateral to the chain of authority responsible for laboratory operations.
d. Encourage all staff members to adopt good Quality Assurance practices, at all levels of the organization and to perceive audits as an educational opportunity.
The scope of internal systems audits of lab operations should include, but is not limited to the proper execution of:
a. Electronic and paper documentation and filing associated with sample and data handling and all ancillary or support procedures, to include procedures employed to track all records pertinent to any sample results.
b. All sample log-in, trafficking, log-out and disposal.
c. Sample preparations.
d. Calibrations.
e. Sample analyses.
f. Data reduction, validation and reporting.
g. Standard and reagent preparation and storage.
h. Waste disposal and segregation.
I. Non-contaminating practices and the design/maintenance of non-contaminating laboratory environments.
j. Container and labware decontamination and storage.
k. Preventative maintenance and repair procedures.
l. QC management practices and assessment of analytical precision, accuracy and sensitivity.
m. proper promulgation and execution of established written procedures.]]
12.2.2.2 Requirements For Internal Performance Audits
Conduct blind, internal performance audits on all analytical systems employed to report data used by DER. These audits shall be conducted at least semiannually.
General requirements for internal performance audits are:
a. Obtain QC samples of certified assay from external sources or vendors, or prepare QC check samples internally.
b. Samples may be composed in artificial matrices such as analyte-free laboratory water or in other matrices whose characteristics are well delineated and can be consistently controlled from sample to sample.
c. Analysts whose systems are to be audited shall not be made aware of the concentration values or the compound names of constituents of the audit sample. They may be informed of the nature of the samples or the audit samples may be inserted into the routine laboratory sample analysis train without the knowledge of the affected analysts.
d. Replicated analysis of the audit samples is discretionary. However, all routine QC procedures and sample handling procedures must be followed when analyzing performance samples. This is required in order that the performance audit may best represent the actual routine operations for the system.
12.2.2.3 Documenting and Reporting Internal Audits
Document all aspects of the audit. Retain all standard forms used in the audit, as well as all notes and final reports. Distribute audit reports or deficiency lists and corrective action orders to appropriate management staff affected, and verify execution of satisfactory corrective actions with follow-up documentation (see Section 11). Provide copies of all of the above to all staff at all levels involved in the audit or whose system area was affected. The following may also be included in all documentation and reports:
a. Audit dates.
b. Auditor names.
c. Systems audited.
d. Parameters analyzed in performance audits.
e. Analysts involved in performance audits.
f. Personnel interviewed for systems audits.
g. All supporting documentation solicited or submitted in support of any systems, performance or data-package audit.
h. Narrative description or report of findings, including summary charts and tables.
I. Report condensations for executive summaries.
j. Statistical evaluation report for performance audit analytical results.
k. Recommended or required corrective actions.
l. List of personnel for report distribution and follow-up responsibilities associated with corrective actions.
1. All field and laboratory audits are subject to the requirements outlined in Rules 17-160.650 and 17-160.680, F.A.C., of the QA Rules.
2. All project audits are subject to the requirements outlined in Rules 17-160.660 and 17-160.680, F.A.C., of the QA Rules.
3. All audits shall be reported in Quality Assurance Reports to DER (see Section 13).