【干货分享】如何在车间层面实施GMP现场监督？

来源： GMP干货

Quality oversight at the operational level offers many advantages. The company’s quality culture can be positively influenced through close integration.

在 运营 层面的质量监督提供了许多优势。通过紧密的整合，可以对公司的质量文化产生积极影响。

But what is the best way to implement Quality Oversight directly at the shop floor level?

但是在车间层面直接实施质量监督的最佳方式是什么呢？

If there are already Quality Assurance (QA) functions that are operations-oriented and involved prior to introduction of shop-floor QA and, as a result, they have experience with cooperating at a detailed level, this makes the transition easier for both areas. The joint integration and use of lean management tools in day-to-day operations, such as Visual Management, 5S, Kaizen or Standard Work, makes it possible to grow together, develop and improve continuously.

如果在引入 现场 QA 之前，已经有面向 运营 的 QA 部门 ， 并且 他们有在 基层 合作的经验，这 会 使得两个领域的过渡更容易。在日常运营中联合整合 并 使用精益管理工具，如 Visual 、 5S 、 Kaizen 或 Standard Work ，使其能够共同成长、不断发展和改进。

For the successful introduction of operational quality oversight into the company, there are a number of aspects to consider.

为了成功地将运营质量监督引入公司，有许多方面需要考虑。

Such an introduction is a conscious decision for cooperation between Quality Assurance and Operations. It offers the opportunity to break down barriers between departments. Basically, it takes time, resources and support from management to make this a lasting success and to realize the potential benefits. The aim is to find a good balance between control functions and cooperation on problems and improvements.

这样的引进是质量保证和运营之间合作的一个有意识的决定。它提供了打破部门之间障碍的机会。基本上，这需要时间、资源和来自管理层的支持，才能使其取得持久的成功并实现潜在的利益。其目的是在控制职能与合作解决问题和改进之间找到一个良好的平衡。

Success factors for operational Quality Assurance (shop-floor QA)

运行 QAA 的成功因素（ 现场 QA ）

Shop-floor QA employees possess expertise and have experience in theappropriate areas.

现场 QA 员工拥有相应领域的专业知识和经验。

Shifts are staffed sufficiently and consistently.

轮班人员配备充足且一致。

Tasks and responsibilities are clearly assigned to QA and Operations.

任务和职责明确分配给 QA 和运营部门。

Clear communication and reporting lines are maintained.

保持清晰的沟通和 汇报 线。

An essential basis for cooperation is that the QA employees are accepted by the Operations employees. The following factors play an important role here:

合作的一个重要基础是 QA 员工被运营员工所接受。以下因素在这里起着重要作用：

• Experience and knowledge of products and processes and the quality requirement

• 对产品、工艺和质量要求有丰富的经验和知识

• Communication skills

• 沟通技巧

• Decision-making ability

• 决策能力

• Ability to deal with conflict

• 处理冲突的能力

Important QA tasks are of observational and evaluative nature, meaning that Operations employees may be irritated by negative feedback. This may lead to heated discussions about the competence and experience of QA employees. Soft skills such as the ability to communicate effectively, to make decisions and to deal with conflict are therefore important in addition to professional competence. Careful consideration must be given to deploying QA employees who previously worked in precisely this Operations unit.

QA 重要的 任务是观察和评估性质的，这意味着运营员工可能会被负面反馈激怒。这可能会引发关于 QA 员工能力和经验的激烈讨论。因此，除了专业能力之外，诸如有效沟通、决策和处理冲突的能力等软技能也很重要。在部署 QA 员工时，必须仔细考虑之前在该运营部门工作的人员。

The implementation process should be monitored by managers. It must be made clear that the main purpose of monitoring is to improve processes and products and thus ultimately patient safety. This should be communicated as a common goal. Shop-floor QA should not see itself and carry itself purely as a supervisory unit.

实施过程应由管理人员监督。必须明确的是， 监督 的主要目的是改进工艺和产品，从而最终确保患者的安全。这应该作为一个共同的目标进行沟通。 现场 QA