Quality System Procedure - Control of Records

Most recently edited by: Paul VanderWeele
Most recent edit date: June 14, 2021
Edits were authorized by: Paul VanderWeele

Purpose

To identify, collect, index, access, file, store, maintain, protect, backup, and dispose quality and technical records. To outline procedures for the protection and backup of data/records held on computers.

Scope / Field of Application

This procedure applies to all quality and technical records. Quality records include audit reports, management review, corrective action requests, and preventive action requests. Technical records include observations, calculations, derived data, calibration records, personnel records, and test reports.

Note - Forms are not records until they are completed.*

Responsibilities

Quality Management Team Members:

  • Specify any alternative retention period

  • Ensure that records specified in the Quality Management System are handled in accordance with the requirements of this document

  • Ensure the unique indexing of records

All Personnel:

  • Collect, store, and maintain records for the minimum retention period or the period designated by the Quality Management Team

  • Ensure that records retained are legible

Materials Required

Entire collection of Quality System Records.

Procedure

Identification

Records are appropriately identified by a descriptive title clearly labeling the record.

Collection

The personnel/user identified for each record is responsible for collecting the record.

Indexing

Each record is assigned a unique name, number or alphanumeric identification, and date to distinguish it from other records with the same identification. This index may also be denoted by the IPv4 Address, MAC Address, and Directory Path.

Accessing

Records are readily accessible to individuals requiring information contained in the record.

Records are available to customers for the period agreed to per customer agreements. Subcontractor’s records, as specified by contract, are made available upon request.

Filing

Filing is considered the location where active records are kept. All records are physically or electronically filed by a method which enhances accessibility and retrieval by a user.

If electronic files are used, a backup system or other suitable measures to prevent record loss is implemented. Data may be stored on hard disk drives, flash drives, or network drives. All data storage drives are maintained for a minimum of 7 years after data is reported. Chemistry records are maintained for a minimum of 10 years, and Lead and Copper are maintained for a minimum of 12 years. Complete backups of on-site server files and LIMS are made each morning and evening, and off-site files are kept on two backup drives that rotate in the building weekly for updating. Daily backups of on-site data is retained for a minimum of two weeks. Two backups are maintained on-site, and at least one rotating backup drive is stored off-site to provide resistance to theft, fire, and flood damage. The LIMS production server and the development workstation are serviced by a same day 4 hour response time on-call employee. The software applications are supported by software maintenance contracts from software vendors. Parts of the servers and development workstations are protected by UPS systems to guard against power surges/outages. The hard disk drives are duplexed and mirrored.

Retention

A record’s “retention” time refers to how long it is kept before it is either discarded, destroyed, or encrypted and compressed for long-term storage. Records are retained on-site for the minimum retention time of 12 years for lead and copper, 10 years for all other chemistry, and 7 years for all other records. Records may be retained longer than the minimum retention time for the convenience of the laboratory. Retention times for work area-specific records are determined by the laboratory and stated in their quality management system documents.

Maintenance

All records are filed and stored in an office or laboratory environment unless specific media and/or special environmental control is specified to prevent damage, deterioration, or loss.

Storage

After the appropriate retention time, records are stored long-term as defined by the Technical Manager.

Disposition

Records are disposed when the retention time has been exceeded. Disposition may be to discard or destroy the records, or as instructed by the Quality Management Team. The Quality Management Team may opt for long-term storage of records.

Documentation

Typical records maintained in the laboratory include: Instrument and equipment maintenance logbooks Calibration record of instruments and analytical processes Records associated with test method quality control plans (e.g., control charts) Records associated with approved SOPs Spreadsheets used to calculate accuracy and precision of instruments Standard logbooks Sample logbooks Analyst notebooks * Sample preparation notebooks

Recent Changes

  • Migrated content to Markdown/MKDocs/Git
  • Changed terminology to fit with new Quality Management Team
  • Updated information on off-site backups
  • Cleaned up obsolete policy
  • Renamed to QSP - Technical Records