What is Laboratory Quality?
Laboratory quality can be defined as accuracy, reliability, and timeliness of reported test results. Every Laboratory should have standardized forms to support the Laboratory Quality system. Once the forms are used to record information, they become records.
What are Records?
Records are the proof of the Laboratory quality and they must be maintained in order to be accurate and accessible. A major goal of keeping records is to find the information whenever it is needed.
Records are the collected information produced by the laboratory in the process of performing and reporting a laboratory test. Records represent proof about various activities that have been performed according to the defined instructions. Laboratory Records help track the sample throughout the process, identify problems, help decision making and are proof of the testing result.
Every Laboratory should have a system in place for records management. The system should define the creation, identification, management, storage and disposal of all records, both paper, and electronic formats. This system should be defined and explained in an SOP.
General requirements for Records
Records must contain all relevant data to permit investigation of any nonconformity or deviation from the defined instruction. All records should be easy to fill out and should have a unique identification like document code, version and valid date. A list of all Records used by the Laboratory should be maintained in the form of a Logbook.
All data should be entered in the original form and in a timely manner. Every data entry in a record should be signed and dated by the operator and the supervisor or the reviewer, where applicable. Each entry of every record should be traceable to the analyst who had performed the testing and to a uniquely identified test.
All records should contain sufficient information to allow an audit trail to be established showing who did what work and how and when it was done. Critical findings should be checked by a second authorized person. If the reviewer disagrees on any point in the initial record, the reason(s) for the disagreement and any action taken should be recorded.
Only a blue ink pen is to be used. A pencil should not be used, because the data can be easily deleted or changed. Records themself should not be deleted. In case of any mistakes, correction should not hide the original record and should be signed and dated by the person who made the correction, with the explanation of why the correction was made, if applicable. The error should be crossed out and the correct entry should be re-entered clearly. “Write Over” or the use of “White-Out” is not acceptable.
In general, all sections/columns of the form should be filled up or answered. An “N/A” is recommended for sections/columns that are not applicable to the specific circumstance.
Records should be kept in a safe and secure place, to prevent damage, deterioration, unauthorized access or loss, for a defined period of time. Most records should be retained for a period of 1 year after the expiry date of the product or 5 years, which one in longer. Storage of the records must be given careful consideration, as the main goal of records is finding the information when it is needed. All records should be filed systematically to make retrieval easy.
The retention time for records can also be determined based on other factors:
The retention time for records can also be determined based on other factors:
- the length of time the laboratory will need to have access to its records
- government requirements or standards that dictate record retention times
- whether the laboratory is engaged in ongoing research requiring many years of data
- the time interval between the laboratory’s assessments or audits
Records for disposal should be treated as confidential waste and should be torn or shredded prior to disposal.
For electronic records, the laboratory should have a system in place to keep original electronic records safe, for example, by creating backups of computer files, and to identify any changes in order to ensure their integrity and confidentiality. Electronic records and signatures must be equivalent to paper records and signs.
Types of Records
There are two types of records in the Laboratory, quality records, and technical records. Quality records include records regarded to Quality systems like audit reports, proficiency tests, customer feedback, corrective and preventive actions, management reviews, etc.
Technical records include all records related to the testing, including sampling forms, test notes, spectras, calibration, quality control data, instrumental operating parameters and print-outs, reports, instrument maintenance records, etc.
Standards and Guidelines
There are various standards and guidelines that are applicable to the Quality Control Laboratory. Each one has defined guidelines regarding records and records maintenance.
- ISO 9001 – provides guidance for quality in manufacturing and service industries, and can be broadly applied to many other kinds of organizations. Addresses general quality management system requirements.
There are two ISO standards especially focused on laboratory accreditation:
- ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
- ISO 15189 Medical laboratories—requirements for quality and competence
Other important international standards for laboratories have been developed and provided by the Clinical and Laboratory Standards Institute (CLSI) by means of a consensus process from many stakeholders including the global laboratory community. These CLSI consensus-based medical laboratory standards are addressed to continually improve the testing quality, safety, and efficacy promoting medical care excellence. The quality management system model generated by CLSI is based on 12 key elements and is fully compatible with ISO standards for laboratories. The CLSI has published two prominent reference documents for the clinical laboratory:
- A Quality Management System Model for Health Care (Document HS1-A2)
- GP26-A4 Application of a Quality Management System Model for Laboratory Services
- Good laboratory practices (GLPs) represent a quality management system related with organizational processes and normalized conditions, under which nonclinical health and environmental safety studies are planned, performed, controlled, recorded, archived, and informed.
- Good manufacturing practices (GMPs) specifically control the production variables that affect the final quality of medications according to the quality standards appropriate to the intended use.
- 21 CFR Part 11 Electronic Records; Electronic Signatures (the European version of this regulation is Annex 11).
- There are many other standards for laboratories that are conducted only to specific laboratory areas, analysis, or programs and zones such as the standards developed by the World Health Organization (WHO), and some countries have even provided national quality standards for laboratories.
Laboratory records include:
- Personnel records
- training logs
- Instrument and equipment records
- installation records
- validation (qualification) records
- maintenance logs
- cleaning logs
- Calibration records
- Sample records
- sample registers
- sample testing records
- Analytical methods records
- transfer records
- validation records
- Quality Control (QC) records (Laboratory workbooks)
- quality control data
- test results
- instrument printouts
- Out of specification records (OOS)
- Stability testing records
- Temperature and Humidity Logs
- Cleaning records
- cleaning logs
- sanitization logs
- External quality assessent or proficiency testing records (PT schemes)
- Results of internal and external audits
- Continuous improvement projects
- Incident reports
- User surveys and customer feedback
- Critical communications (e.g. letters from regulatory agencies, government or administrative offices within the healthcare system).
Records are laboratory information, either written by hand or computer-printed. They are permanent, and should not be revised or modified. They should be complete, legible and carefully maintained, as they are used for continuous monitoring, tracking of samples, evaluating problems and management.
Laboratory control records should include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays.
One sample testing should include the following records:
- A description of a sample received for testing
- A statement of, or reference to, each test method used
- Weight of sample used for each test
- Data on, or cross-reference to, the preparation and testing of reference standards, reagents, and standard solutions
- A complete record of all raw data generated during the test, in addition to graphs, charts, and spectra from laboratory instrumentation, all properly identified to show the specific material and the batch tested
- A record of all calculations performed in connection with the test including, for example, units of measure, conversion factors, and equivalency factors
- A statement of the test results and how they compare with established acceptance criteria
- The signature of the person who performed each test and the date(s) on which the tests were performed
- The date and signature of a second person, showing that the original records were reviewed for accuracy, completeness, and compliance with established standards.