The internal audit is important for the management system of laboratory .The article stated how to effectively implement internal audit in drug testing laboratories in terms of the planning , checklist, pattern, problem observation , CAPA of non-compliance and application of results in internal audit .

To understand the status of testing skills and quality management in drug testing laboratories. Methods:The items, pass rate and type of participating laboratories of measurement audit were analyzed during 2011-2014. Results:The number of application items was increased year by year, more than half of which focused on the content determination, and the overall pass rate was over 80%. Conclusion:The measurement audit is important for laboratories, which should be further strengthened and standard-ized.

BACKGROUND: The Childhood Experience of Care and Abuse Questionnaire (CECA.Q) compiled by the Institute of Psychiatry, University of London, has been verified to have good reliability and validity in the assessment of foreign community adults and patients with affective disorder,but the application of CECA.Q in China still needs verification of reliability and validity in various population.OBJECTIVE: To analyze the reliability and validity of CECA.Q in community population.DESIGN: The subjects were randomized selected; the principle for the analysis of scale reliability and validity was followed.SETTING: Mental Health Institute of Central South University.PARTICIPANTS: From September 2003 to February 2004, 608 adults were selected from two communities of Hunan Changsha city and Henan Xinxiang city as the common community population group, totally 608scales of CECA.Q were sent out, 8 invalid ones were excluded, and finally 600 subjects finished the investigation. Sixty adult inpatients with depressive disease were randomly selected from Henan Provincial Psychiatric Hospital as the depression group.METHODS: The common community population and patients with depressive disease were investigated with CECA.Q, which was a self-rating scale mainly to retrospectively survey whether the adults had suffered from physical, sexual or mental abuse in their childhood, and the mental abuse had two factors of antipathy and neglect, and each included 8 items. The answers for the items were quantified into 5 grades. The subjects evaluated whether their parents had given any abuse to them; the higher the score was, the greater the mental abuse they suffered. Of the community population, 40 cases were the positive samples with the history of physical and sexual abuse in childhood evaluated by CECA.Q, and they were then assessed with Bifulco provided childhood experience of care and abuse (CECA) together with 40 cases randomly selected from 560 samples with negative evaluation. A total of 100 cases in the community population were also evaluated with Zung self-rating depression scale (SDS), besides, 30 cases were retested with CECA.Q at 2 weeks after the first evaluation.MAIN OUTCOME MEASURES: The internal consistency, test-retest reliability, contents and criterion validity of CECA.Q were analyzed. RESULTS: Of the community population, 8 invalid questionnaires were excluded, and the other 600 cases entered the statistical analysis. ① Testretest reliability of CECA.Q: The Cronbach α coefficient for the mental abuse section was 0.87 (0.85 for maternal one, 0.83 for paternal one); including that of antipathy factor was 0.84 (0.80 for maternal one, 0.81 for paternal one), and that of neglect factor was 0.85 (0.84 for maternal one,.83 for paternal one. The test-retest reliability coefficient for mental abuse as 0.83 (0.81 for maternal one, 082 for paternal one), including that of antipathy was 0.81 (0.82 for maternal one, 0.70 for paternal one), and that f neglect was 0.79 (0.78 for maternal one, 0.75 for paternal one). The twice evaluations of physical and sexual abuse had good consistency (Kappa=0.78). ② Criterion validity of CECA.Q: The correlation coefficients of mental abuse, antipathy and neglect factors in CECA.Q with Zung SDS were 0.58, 0.55 and 0.60 respectively (P＜0.01). CECA.Q and CECA had good consistency in evaluating history of physical and sexual abuse, and the score of mental abuse in the depressive patients was higher than that in community population (P＜0.05).CONCLUSION: The CECA.Q shows acceptable reliability and validity in community population, and can be used as a self-rating measure for childhood abuse experience in China.

To assure the effective operation of certification and accreditation in the laboratory management system, further strengthen the instruments and equipment management, and provide specific recommendations on improvement of internal audit, management review and continuous improvement of management system. The inspector program had been firstly established and complemented. Through the inspection, we identified many deficiencies, made many specific recommendations for improvement. After inspection, the working procedures were improved; data from department were more rigorous, scientific and just; hardware foundation was established for international mutual recognition.
Accreditation ; Food Inspection ; legislation & jurisprudence ; Laboratories ; standards ; Pharmacy Administration ; legislation & jurisprudence