Synopsis

Records and Record Keeping is the companion to document and document control for assuring data of known and documented quality. It is the other side of the equation. Managing the tremendous amounts of measurement and support data required for proper historical reconstruction can be a monumentally frustrating task. It all starts with understanding the requirements and designing the quality management system to be compliant, complete yet practical and easy to use. While the TNI Standard has specific requirements to be met, it provides flexibility on how records are kept and how they are managed. It is important for management to consider technology, storage mechanisms, traceability, archiving and retrievable of records. Paper versus electronic and the use of LIMS systems needs to be factored into the equation.

This webcast focuses on the Standard's provisions and potential options to defining how records are kept. There is no one solution. Solutions must be tailored to the organizations needs and operation. What needs to be recorded, how to record, how to manage and store records for easy access and to minimized resource needs will be discussed and examples will be presented for consideration. Some of the challenges that have been observed in assessments will be presented and discussed. What tools are available to labs? Do electronic distribution and management really work? What are the considerations when considering and blending paper records with electronic records.

Learning Objectives

Understands
- The procedures for identification, collection, indexing, access, filing, storage, maintenance, and disposal of quality and technical records.
- The procedures to protect and back-up records stored electronically and to prevent unauthorized access to or amendment of these records.
- The types of technical records to be controlled, including records such as original observations, derived data and sufficient information to establish an audit trail, calibration records, and a copy of each test report issued.
- Record retention requirements, including requirements from outside sources such as contracts, permits, or state and/or federal regulations.
- The data required for proper historical reconstruction.
- How to consider technology, storage mechanisms, and traceability for archiving and retrievable of records.
- Differences between paper and electronic records and the use of Laboratory Information Management Systems (LIMS).
- What needs to be recorded, how to record it, and how to manage and store records for easy access and to minimize resource needs.
- Observations, data and calculations are recorded at the time they are made and identifiable to the specific task.
- That when mistakes occur in records, each mistake is crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All alterations to records are signed or initialed by the person making the correction.
- That in the case of records stored electronically, equivalent measures are taken to avoid loss or change of original data.
- A record keeping system that allows the history of the sample and associated data is readily understood through the documentation, including unequivocal, accurate records that document all laboratory activities such as laboratory facilities, equipment, analytical methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification, and inter-laboratory transfers of samples and/or extracts.

Audience

Quality Managers, Technical Managers, Laboratory Managers, Laboratory Assessors

Digital Badges Associated with this Course

Records and Document Control Specialist