大型食品制造商最近经历了美国食品药品监督管理局的首次味道食品安全现代化法案（FSMA）。截至2016年9月19日，拥有人类食品设施的大型企业（500名或更多员工）必须遵守有关预防控制和当前良好制造实践（CGMP）的新标准。小型食品制造商必须在今年9月之前遵守，然后再进行外国供应商验证计划（FSVP），卫生运输食品的卫生运输以及围绕有意掺假的食物防御措施的更多最终规则。
While manufacturers focus on creating a hazard analysis and risk-based preventive controls (HARPC) plan, it is critical to the future health of these organizations to understand what the FSMA guidance says and what Food and Drug Administration (FDA) inspectors will be looking for during plant audits. To that end, this is not just a management or technology issue, but a business matter that requires engagement with a company’s legal department.
That was the message delivered by Elizabeth Fawell, counsel at legal firm Hogan Lovells. Fawell specializes in food regulations and was a presenter at theProfood Tech本周在芝加哥举行会议。FDA可能会敲打任何植物地板进行审计，该练习包括审查记录，采用产品样品来检测病原污染，并收集可用于公司的证据。如果检查人员走出去时，您将获得483表格报告（概述违规行为），这可能会给公司带来麻烦。而且，据记录，在召集违规行为时，FDA并不害羞。在FDA 2016财政年度的检查观察摘要中，向食品公司提供了2,196份483个表格。
Understanding that the FDA could be coming your way, it is important to engage with the company’s legal department early on. “You don’t want to get a warning letter and that’s the first time general counsel knows you had an inspection,” Fawell said. “They need to know when an inspection is conducted so they can respond to a 483.” Similarly, plant managers and their team must be well-versed on the company’s food safety plan, which means being able to discuss procedures and scientific justification in detail. “And know what records to pull. A lot of folks will have all the documentation but when the FDA says ‘let’s see the procedures for the metal detector,’ they don’t know exactly what to pull. You need to have that mapped out ahead of time.”
There are many open questions about pending regulations that remain, such as the verification of the suppliers’ suppliers or the definition of an “importer” for FSVP purposes, so it is important to have the team stay on top of FDA movements. For example, last year the FDA initiated a team called Strategic Coordinated Oversight of Recall Execution (SCORE), a cross-functional team of senior FDA leaders who will address challenging recall situations and speed up response when foods represent a danger to consumers’ health. Why watch this team? Because they are expanding their scope to preventative control inspection. “We need to prepare for quick responses and understand this team—who is on it and what their role is in making and enforcing decisions,” Fawell said.
还要记住技术进步，例如全基因组测序，可以在产品样本和病患者之间进行精确匹配。她说，监管机构正在建立消费者中发现的疾病菌株数据库，“这意味着将公司的产品和工厂环境与食源性疾病联系起来将变得越来越容易。”
Fawell继续强调，FDA将期望工厂经理解释食品安全计划的基础科学理由并提供支持文件。这意味着工厂经理将承担责任，必须建立一个团队，当有多个调查人员对现场进行检查时，可以介入，通过微生物采样进行“拭子 - thon”搜索病原体。
尽管此过程中有许多未知数，但准备检查的最佳方法是了解您的权利，包括公司的政策和程序以及州法律所说的话。此外，Fawell建议采用良好的记录保存实践，为基于系统的检查做准备并了解更新的制造过程。不要忽视良好的制造实践（GMP），并在所有员工都能理解其角色的公司中创建食品安全文化。
“Inspections are changing and will change more as FSMA ramps up,” Fawell said, “and inspectors are eager to use their authority. Keep calm and get ready.”
