食品衛生安全管理系統驗證獨立性之分析

Abstract

食品安全已然成為臺灣社會關注焦點，「食品三級品管原則」則成為近來政府回應食安問題之具體措施，而本文以二級品管—「食品衛生安全管理系統驗證(以下簡稱食安法驗證)」作為研究主題之動機有三：(一)食安法驗證屬命令管制性政策，乃食安管制政策之基礎，研究將有利基礎之鞏固；(二)與同為命令管制性政策的稽查制度相比，其政策推行時間較短，研究量能投入亦少，故更具探索性研究價值；(三)由於稽核員與稽查員同屬基層官僚，故在面臨相似的政策執行時，驗證研究能與稽查研究產生互補。鑒此，本文遂以「食安法驗證」作為研究主題，並以其執行基礎—組織性獨立與操作性獨立作為分析指標，透過深度訪談與參與觀察，從驗證機構與稽核員的角度理解政策執行過程及其獨立性維持之方法與困境，進而作為判斷該政策執行良窳之指標。 研究結果發現，在組織性獨立方面，食安法驗證透過「避免客源競爭」、「收費方式設計」兩項制度安排來降低「經濟依賴關係威脅」，並透過「食藥署認證資格申請限制」、「利益迴避機制」、「驗證資訊公開原則」、「設立公正委員會」、「針對不符合事項訂定矯正措施」、「食藥署與驗證機構之共識會議」、「設立驗證委員會」、「追蹤查驗」、「驗證證明書管理」九項制度設計來降低「代理風險威脅」，然而，即便安排縝密，仍有八項困境存在，包括「仍無法杜絕因食安法驗證而起之競爭」、「IAF會員認證品質落差為食安法驗證之客觀性埋下隱憂」、「利益迴避機制疏於自我審查威脅」、「食安法驗證機構之驗證審議形式不一致」、「食安法驗證之侷限性」、「實地複評與不定期追查缺乏經濟誘因執行」、「稽核員忠實執行稽核之誘因不足」、「驗證機構與衛生主管機關之觀察員規範共識尚未完整」。

而在操作性獨立方面，食安法驗證透過「爭取廠商信任」、「掌握稽核節奏」兩項策略來降低「廠商控制現場稽核場域變數威脅」，並採取事前準備、事中策略、事後評估三項計畫來降低「稽核模式差異威脅」，然而，食安法驗證在操作性獨立層面，目前仍無法避免「法律授權不足」、「專業稽核員規模不足」、「食安風險日新月異」三項困境。簡而言之，食安法驗證確實極為注重獨立性之維持，然而礙於諸多非驗證機構與稽核員所能掌握之限制因素，使得食安法驗證之獨立性仍有待改善之處。

最後，基於研究分析結果，本文針對組織性獨立提供六點建議：(一)食安法驗證應與商業行為脫鉤；(二)ISO認證申請在地化；(三)衛生管理相關單位對於稽核準則之解釋應達成共識；(四)食安維護責任應由廠商承擔；(五)應調整食安法驗證之行動誘因機制；(六)驗證機構與衛生主管機關應針對觀察員規範達成共識；而針對操作性獨立則有兩點建議：(一)完善驗證機構之法律授權；(二)政府投注資源培養稽核人才。

Food safety has become the-main concern in Taiwan society. To respond the problem, the government has adopted 'Three-tier Quality Control System for Food Safety' as a concrete measure. The purpose of this research, which focus on the Second-tier Quality Control System – 'Mandated Food Safety and Sanitation Certification' (hereinafter referred as 'the Certification'), aims at three dimensions: (a) 'the Certification' is one of the regulatory measures that can be found as the base food safety control policy, so the study may be conducive to the consolidation of the foundation. (b) Compared with the auditing system, which is command and control policy as well, 'the Certification' implementation requires shorter time and less investment, hence the exploratory research value is relatively high. (C) Both the inspectors and the auditors belong to the grassroots bureaucracy, and in some executive procedures, their surveys can complement each other. Therefore, the dissertation takes 'the Certification' as the topic and the principles of implementation – organizational and operational independence – as the analytic criteria. In addition, the investigation adopts the qualitative method with in-depth interviews in order to examine the implementing process of 'the Certification' and the officials’ ability to maintain their independence through participants’ observation. The information is used as the indicators to evaluate the validity of the implementation of the policy. As the result, the study found that, in terms of organizational independence, 'the Certification' validated the reduction of the 'economic dependency threat' through two institutional arrangements: 'avoiding competition in customer sources' and the 'charging mechanism', and through the 'restriction of application for FDA's accreditation', 'avoidance mechanism of interest conflicts', 'principles for the certification of information disclosure', 'establishment of Justice Committee', 'corrective measures for noncompliance', 'consensual assembly between FDA and Certification Bodies', 'establishment of Certification Committee', 'tracing inspection', 'certificate management' nine measures to reduce the 'agency risk threat'. Nevertheless, there are still eight predicaments, including 'the incomplete avoidance of competition aroused from ’the Certification’', 'the uncertainty of the objectivity of ’the Certification’ caused by the member quality gap of IAF accreditation', 'the self-examination risk of avoidance mechanism of interest conflicts', 'the non-accordance between the forms of certification decision within Certification Bodies', 'the limitation of ’the Certification’ itself', 'the lack of economic incentive to issue field re-inspection and occasional tracing', 'the insufficient incentive for inspectors to inspect faithfully', 'the incomplete agreement between the Certification Bodies and the health authorities.' In terms of operational independence, 'the Certification' adopts two strategies of 'seeking manufacturers’ trust' and 'managing the inspection rhythm' to reduce the 'the threat from the manufacturers controlling the variables of inspection field'. Furthermore, it takes three projects, including beforehand preparation, halfway strategy, and afterward assessment, to reduce 'the threat caused by inspection model differences'. However, 'the Certification' at the operational independence level, is still unable to prevent form difficulties such as 'insufficiency of legal authority', 'the shortage of professional inspectors', and 'food safety risks daily changes '. In short, 'the Certification' is indeed focused on the maintenance of independence, but due to various constraints which are beyond the Certification Bodies and the inspectors’ control, the independence of 'the Certification' remains to be improved.

Finally, based on the results of the study, this paper concludes with six recommendations for organizational independence: (a) 'the Certification' should be separated from commercial activities. (b) The application of ISO accreditation should be localized. (c) The health authorities and Certification Bodies should reach a consensus for the interpretation of the inspection guidelines. (d) Manufactures should take the responsibility of maintaining food safety. (e) The incentive mechanism of 'the Certification' implementation should be adjusted. (f) The health authorities and Certification Bodies should agree on the norms for the observers. On the other hand, there are two suggestions for the operational independence: (a) Improve the legal mandates of the Certification Bodies (b) The Government should invest resources in cultivating inspectors.