Evaluation of quality control measures and competency of the staff in non-accredited testing laboratories in sri lanka

Abstract

The purpose of this research was to identify the quality control measures adopted by non-accredited testing laboratories (excluding medical and calibration laboratories) in Sri Lanka and to examine the competency of the staff in conducting the tests in non-accredited laboratories using ISO 17025 as the guidance. A field study based on a structured questionnaire and personal interviews was carried out in ten (10) non-accredited laboratories in Sri Lanka. Eighteen test methods (18), twenty one (21) actual tests were observed and twenty four (24) employees were given a structured examination. The study analyzed non-accredited laboratories based on management and technical requirements of ISO 17025. Several specific clauses stipulated in ISO 17025 were considered for the assessment. Each clause selected was subdivided in to a set of objective requirements which was examined in each laboratory/test method/test. The laboratory was decided to have complied with minimum quality control procedures related to the clause if these requirements are met as per the acceptance criteria developed by the researcher. The study identified that less than 40% laboratories observed, used adequate quality control methods in conducting the tests in aspects related management system, equipment and reporting results. Less than 70% laboratories observed, used adequate quality control methods in conducting the tests in aspects related to internal audit, organizations and laboratory environment. Erroneous procedures and deficiencies in conducting the test were observed in many aspects. Ignorance of conditions laid down in the relevant test method/standard, inappropriate handling of testing equipment or standards by the staff, non-use of quality control samples when required and errors in documentation and issuing of the test report were the four major shortcomings observed in test methods. Three major deficiencies in laboratory quality control included calibration issues, not enough facilities to monitor the test environment and lack of documentation in quality procedures. The study also revealed the poor competency and knowledge of the laboratory staff in general quality principles. Although 56% of the employees examined had sufficient technical knowledge to carry out the given test, only 30% had satisfactory understanding of general quality management policies laid down in ISO 17025. The outcome of this research is that due to inadequate level of quality control procedures implemented in most of the non-accredited laboratories and due to the lack of knowledge of the staff in these testing laboratories in quality assurance principles, the ability of non-accredited laboratories to consistently deliver reliable and valid results is highly doubtful. Finally, this paper presents recommendations for an effective and reliable laboratory network in Sri Lanka.