| 摘要: | 本研究之目的為了解2011~2017年「台灣中藥廠從業人員GMP作業之教育訓練」課程，對學員之幫助度及對未來課程需求之規劃，以問卷方式透過調查及資料統計分析，將結果作為未來人才培訓之參考。共發放240份，有效回收率85.0%。以Excel 2017及SPSS 12版套裝軟體進行描述性統計分析、獨立樣本t檢定、單因子變異數分析。
綜合分析結果 (1)受訪者大部分為基層員工，占41.2%；在辦理之教育訓練課程有55位受訪者未上過課，占65.5%為基層員工，顯見藥廠基層員工流動率很高、廠內對於員工基本教育訓練仍不足，新進人員被安排接受教育訓練機會少。(2)有77.5%受訪者認為外部教育訓練不足夠，40.2%認為主要原因是開課單位太少，顯見中藥廠從業人員之教育訓練應持續辦理，政府應多與學校、法人機構、相關政府部門、公協會宣導辦理人才培訓課程，以促進整體產業人才能力之提升。(3)有30.4%受訪者認為每年應該至少有24小時的教育訓練課程，有42.7%認為理想上課人數是30-60人，以小班制實務教學方式辦理。(4)十四大項課程中，沒有上過課的人數百分比為46.6%~73.5%；又以1.品保及品質系統常見缺失2.GMP後續查廠之查核重點兩項課程平均幫助度分數最高，為4.36分。顯示中藥廠從業人員受益僅約占50.0%左右。因衛生福利部並沒有明確政策宣示中藥廠GMP製造法規要提升與國際接軌，業者持觀望態度，以先了解政策趨勢為首要，加上業界持反對態度，藥廠亦無實際執行提升各項品質系統之壓力，故受益不大。(5)因應國際趨勢，綜合所需之教育訓練課程項目，將針對國內現行法規政令、文件管理系統、品質管制系統、品質管理系統、確效作業、及實作課程做為未來課程規劃之參考。
The target of this study was to understand the degree of help to the trainees in the “Education and Training of Practitioners for GMP Operations in Taiwanese Chinese Medicine” conducted during 2011 and 2017, and to provide as a reference for future program planning. With the questionnaires for statistical analysis of survey and information, the results will be provided as a reference for future personnel training. A total of 240 questionnaires were released, the effective recovery rate is 85%. The software applications Excel 2017 and SPSS 12 edition were applied for descriptive statistical analysis, Independent-Sample t test, and one-way analysis of variance.
The results of this study are summarized as follows:(1) Most of the respondents were junior staff, accounting for 41.2%; 55 of which had not attended the education and training courses conducted in 2011-2017, accounting for 65.5% of the junior staff. It is obvious that the turnover rate of junior staff in pharmaceutical companies was high, still insufficient for the basic education and training of employees in the factories, and the opportunities to receive education and training were few for entry level employees. (2) 77.5% of the respondents believed that external education and training was insufficient. 40.2% of which believed that the main reason was insufficiency of training units. It was obvious that the education and training of the practitioners of Chinese medicine companies should be carried out continuously, and that the government should promote and conduct more training courses with schools, foundations, relevant government departments, and public associations to implement personnel training programs, so as to enhance the professional ability of overall industry.(3) 30.4% of the respondents believed that there should be at least 24 hours of education and training programs per annum; and 42.7% of them believed that 30 to 60 should be the ideal number of attendance; and a small-class practical training should be implemented.(4) For the respondents participating in the 14 major programs of "Education and Training of Practitioners for GMP Operations in Taiwanese Chinese Medicine" conducted during 2011 and 2017, the percentage of persons who had not attended training courses was 46.6% to 73.5%, and the courses that helped the respondents the most was 1.The quality assurance and quality system are often missing.2.The GMP follow-up inspection of the key points of the two courses has the highest average help score of 4.36 points.signifying that the training courses of Chinese medicine practitioners for GMP operations benefited only about 50%. Therefore, during that time, the Ministry of Health and Welfare did not clearly declare that the GMP manufacturing regulations of Chinese medicine companies should be updated and in line with the global standards; so the companies was sitting on the fence. For them, it was their priority to comprehend the trend of government policies; furthermore, due to the opposition from the industry, the pharmaceutical companies also have no pressure to conduct improvement for each of their quality systems, so the benefits were not great. (5) To meet international trends, comprehensive education and training programs are required, such as the existing domestic policies & decrees, document management system, quality control system, quality management system, validation operation, and practical programs are focused as the references for future program planning. |
