
第一个主要合规性日期食品药品监督管理局的食品安全现代化法案(FSMA)occurred on September 19, 2016. It requires large manufacturers of human and animal food to meet preventive controls and Current Good Manufacturing Practice (CGMPS) requirements. That means having a safety system in place that includes an analysis of hazards and risk-based preventive controls.
In order to meet these requirements, the FDA has recommended that food companies set up a thorough system for documenting what they do in order to demonstrate they are meeting the legal criteria. In addition, companies are required to put processes and procedures in place that prevent problems in the first place.
好消息是,大多数公司都准备向FDA代理展示他们和当前和未来的食品安全法规。根据《自动化世界调查》,有74%的受访者表示,他们有望满足FSMA围绕食品安全,卫生运输和外国供应商验证计划的FSMA要求。大多数公司(86.5%)满足了第一个合规要求,主要是因为它们已经具有危害分析和关键控制点(HACCP)计划,该计划是具有类似预防控制规则的食品安全管理系统。
Key to HACCP enforcement—like FSMA compliance—is documentation, and 70.3 percent of respondents said they use a document management system to identify possible hazards in the food production process. The other technologies companies said they have in place as part of their HACCP plan include quality management systems (85.6 percent), a historian database (53.2 percent) enterprise resource planning (42.3 percent). Additional technologies in use include sensors and intelligent algorithms (35.1 percent) and food production management software (28.8 percent).
技术是FSMA的关键因素,因此,合规性的最大障碍是新的技术投资和实施,其次是数据管理和分析以及缺乏技能和资源,这也就不足为奇了。一位受访者说:“我们正在不断改善我们的数据管理和分析,准确的记录保存,质量控制和培训。”
此外,制造商还密切关注供应链的标签 - 调查结果表明,整个制造商中有92%正在通过供应链跟踪产品和材料。不幸的是,仍然有一些工作要做,因为有55%的人表示供应链可追溯性“相当不错,但需要一些改进”。同时,另外28%的人认为他们的供应链管理是“最好的班级”,13.5%的人表示,他们需要完整的过程来执行此操作,其余的受访者根本不会跟踪供应链。
For those companies that have supply chain visibility, the majority (70 percent), said that bar codes are their best friends. A small group (20 percent) are even adopting serialization technology as outlined by the Drug Supply Chain Security Act (DSCSA).
因此,当然,在这项调查结束时,我们不得不询问食品和饮料制造商在夜间使它们保持良好的状态。这是一些最常见的响应的简短列表(没有特别的顺序):
- Recalls
- Cost to implement technology
- 确保24x7合规性
- Quality control
- 员工短缺/人才获取
- Traceability
- Documentation
- Security
- 安全
- 停机时间
- And, just keeping up with changing regulations of the FDA.
FDA了解这是食品和饮料行业的新领域。在一个recent article on the FDA websiteFSMA运营团队指导委员会联席主席乔安·吉文斯(Joann Givens)表示,FDA未来的主要重点将是继续教育,培训和技术援助,以帮助公司遵守新要求。但是,她警告说,这并不意味着如果公司不符合新标准,他们将不承担任何责任。她说:“ FDA的任务是保护公共卫生,并在必要时会迅速采取行动。”
因此,对于26%的受访者,他们说他们还没有准备好满足FSMA要求,好吧,您已经被警告。