The article highlights some common issues that commercial testing laboratories cannot afford to overlook at any cost. Such issues often get overlooked because of busy work schedules or simply through oversight. The Quality Manager needs to pay special attention and should ensure regular auditing through scheduling of periodic internal audits. Such audits help not only to streamline laboratory operations but also help bring down non –conformances that can be pointed out by external auditing agencies and regulatory authorities.
The number of lapses and non-conformities can be endless but here some important issues are discussed which can spell doom if due attention is not accorded to eliminate them.
Outdated SOP’s and STP’s in circulation
Standard Operating Procedures (SOP’s) and Standard Test Procedures (STP’s) are standard operating guidelines and test procedures laid down by a laboratory for the upkeep of its defined quality policies. Such documents are issued to respective departments for compliance by the Quality Assurance Manager and have a limited validity which is mentioned in each document. Such documents should be reviewed depending on advances in procedures and test facilities and on the introduction of new resources. Documents which have not been revised and whose validity has expired should be taken out of circulation and destroyed and current versions should be introduced beforehand. At any point in time, only valid documents should be in circulation. Use of invalid documents is considered to be a serious non-compliance.
Non-availability of calibration records
All testing and measurement facilities need to be calibrated against certified reference standards at intervals specified in SOP’s. Records of such activities in the form of log registers and supporting data should be available and updated without fail. Auditors raise serious objections if it is noticed that an un-calibrated instrument was under use. In case instruments or devices are sent to third parties for calibration then calibration certificates of such agencies should be available for inspection at all times.
Use of expired working standards
Working standards required for testing of samples should be stocked under specified environmental conditions and revalidated before expiry dates without fail. Use of expired working standards is a serious non-compliance which can lead to cancellation of license or accreditation of the laboratory.
Discontinuation of training activities
Training is the essence of the sustained growth of laboratories as it helps develop the knowledge and skills of the laboratory workforce. A laboratory needs to provide regular structured training programs to new entrants as well as senior employees to meet this important requirement. In addition training also helps upkeep of safety standards in the laboratory. Operation of advanced sophisticated instruments and optimum use of available application software is unthinkable without regular upgradation of operator skills. Records of training activities should also be maintained for internal use as well as the inspection by regulatory bodies.
No periodic inspection of installed safety devices
It is mandatory for all laboratories to install and maintain safety devices such as fire extinguishers, smoke alarms, spill management kits, eye wash, and safety showers. Periodic inspection of such devices for their proper functioning is also a must. Laboratory staff should also be familiar with their use in time of emergencies. In addition to safety devices, the first aid boxes should also be inspected and expired items should be replaced with fresh stocks.
Laboratory waste disposal
Laboratory waste needs to be disposed of responsibly. It should be segregated and treated as per local guidelines before discharge. Microbiological wastes require specialized treatment before disposal. Non-adherence to waste disposal guidelines can result even in cancellation of license for running the laboratories.
As mentioned earlier the list can be expanded to meet the requirements of laboratories depending on their functional activities and local guidelines. In a nutshell upkeep of records of all activities and reports should be maintained without fail and nothing should be left to chance. Quality Assurance department needs to exercise vigilance at all times to ensure total compliance with the organization’s quality manual and regulatory requirements.