310 CMR, § 42.14 - Maintenance of Records

(1) Certified laboratories shall maintain copies of all analytical reports, logs, charts and records created in accordance with 310 CMR 42.00 for a minimum often years or as otherwise specified by the Department. Records related to performance on proficiency tests shall be maintained for a minimum of five years. Records shall include the results and supporting documentation of analyses of samples including proficiency test samples, reagent blanks, laboratory fortified blanks, laboratory fortified sample matrices and duplicates, and surrogate analyte recovery data. Records of analysis of samples shall include documentation of sample preparation procedures, including, but not limited to, pH adjustments, distillations, digestions, extractions, and turbidity measurements.

(2) Certified laboratories shall record observations, data, and calculations at the time they are made. Handwritten records must be made in ink, not pencil. Mistakes in records shall be crossed out with a single line such that the original entry is still legible and the correct value entered. All alterations to records must be signed by the person making the correction. In the case of records stored electronically, equivalent measures must be taken to avoid loss or change of original data.

(3) Certified laboratories shall maintain current records of personnel, including a resume documenting education, training, experience, description of duties and dates of relevant employment for each employee.

(4) Certified laboratories shall maintain all records in accordance with the Department approved QA plan for the laboratory. The laboratory must ensure that all records, including those stored electronically, are readable throughout the required retention time of the records.

Notes

310 CMR, § 42.14

Amended by Mass Register Issue 1325, eff. 11/4/2016.