Section 096-263-9 - LABORATORY POLICIES AND PROCEDURESA.Quality assurance manual1. A laboratory must possess and follow a written manual of quality assurance.2. The manual may include separate procedures or incorporate documents by reference.3. The manual or its separate procedures must contain the following:b. Identification on each page to ensure that the page is recognized as part of the manual and clear identification of the end of the manual;c. The laboratory's name and address;d. Identification of the laboratory's approved signatories;f. A date indicating when the revision became effective;g. A table of contents, applicable lists of references, glossaries and appendices;h. All maintenance, calibration and verification procedures used by the laboratory in conducting tests;i. Major equipment, support equipment and reference measurement standards (e.g., NIST traceable thermometers and weights);j. Verification practices, which may include proficiency testing programs, use of reference materials, internal QC processes and inter-laboratory comparisons;k. Procedures for reporting analytical results;l. The organization and management structure of the laboratory, its place in any parent organization and relevant organizational charts;m. Procedures to ensure that all records required under this rule are retained, as well as procedures for control and maintenance of documentation through a document control system that ensures that all SOPs, manuals or documents clearly indicate the time period during which the procedure or document was utilized;n. Job descriptions of key staff and reference to the job descriptions of other laboratory staff;o. Procedures for achieving traceability of measurements;p. A list of all methods under which the laboratory performs its accredited or provisionally accredited testing;q. Procedures for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work;r. Procedures for handling samples, including subcontract testing;s. Procedures for collection and transportation of samples, if the laboratory provides this service;t. Procedures to be followed for feedback and corrective action whenever testing discrepancies are detected or departures from documented policies and procedures occur;u. Policy for permitting departures from documented policies and procedures or from standard specifications;v. Procedures for handling complaints;w. Procedures for protecting confidentiality (including national security concerns) and proprietary rights;x. Procedures for data review to include both technical review for accuracy, as well as a careful review for accuracy regarding transcription or other errors in reporting;y. Procedures for internal audits;z. Procedures for establishing that personnel are adequately experienced in the duties they are expected to carry out, as well as procedures for providing necessary training;aa. A policy addressing the use of unique electronic signatures, where applicable; andbb. A description of how data accuracy and precision are determined for each accredited method and analyte within each test category; for example, establishing control limits, preparing control charts and performing calculations.4. The manual must be reviewed periodically and updated when necessary. Documentation of the review process must include the scope of the review, identification and signature of the reviewer, as well as the date the review was completed.B.Standard operating procedures1. Written procedures required A laboratory must possess written SOPs used by laboratory personnel for the analysis of samples. A laboratory must prepare written procedures for all laboratory activities including, but not limited to, sample acceptance, sample analysis, operation of instrumentation, generation of data and performance of corrective action. Only the laboratory technical director or quality assurance officer may approve changes in SOPs. Such changes may be effective only when documented in writing.
2. Quality control (QC) Actual practice must conform to the written procedures. The laboratory must maintain copies of the methods from which the procedures are developed. A laboratory must ensure that the applicable requirements are incorporated into each procedure. All quality control measures must be assessed and evaluated on an ongoing basis. QC acceptance criteria in the laboratory's QA manual must be used to determine the validity of the data.
3. Standard operating procedure requirements a. All SOPs must contain the following: (ii) A unique identification of the SOP, such as a serial number, an identification on each page to ensure that the page is recognized as a part of the manual and a clear identification of the end of the manual;(iv) The laboratory's name; when several separate procedures are included in the manual the name must appear on each procedure;(v) A revision number; and(vi) A date indicating when the revision became effective.b. Each analytical method SOP must include or reference the following topics where applicable: (i) Identification of the method;(ii) Applicable matrix or matrices;(iii) Limits of detection and quantitation;(iv) Scope and application, including parameters to be analyzed;(v) Summary of the method;(ix) Equipment and supplies;(x) Reagents and standards;(xi) Sample collection, preservation, shipment and storage;(xiii) Calibration and standardization;(xv) Data analysis and calculations;(xvi) Method performance;(xvii) Pollution prevention;(xviii) Data assessment and acceptance criteria for QC measures;(xix) Corrective actions for out-of-control data;(xx) Contingencies for handling out-of-control or unacceptable data;(xxii) References, including revision number or letter and publication date; and(xxiii) Any tables, diagrams, flowcharts and validation data.4. Availability A copy of each written procedure must be available to all personnel that engage in that particular activity.
5. Required use An analyst must use the laboratory's SOP beginning on the effective date for all laboratory activities for the analysis of samples for which accreditation is required.
6. Effective dates A laboratory must maintain a record of effective dates for all procedures. A copy of the procedure and the record of effective dates must be maintained for the same period of time that records of the data generated by those procedures are required to be maintained.
7. Copy to accreditation officer A laboratory must submit an electronic copy of its laboratory SOPs to the accreditation officer at the time of application.
8. Changes All changes to the SOPs must be documented. Changes to the SOPs must be incorporated at least annually. All updated SOPs must include the signature of the managing agent upon revision.
06-096 C.M.R. ch. 263, § 9