QMS实施最佳实践：规划采用至关重要（一）

While choosing the right EQMS solution is critical, real customer success happens when implementation is well-planned, keeping in mind user adoption and balancing between short-term and long-term goals.

选择正确的EQMS解决方案非常重要，但真正的客户成功发生在实施阶段，需要进行良好的规划，考虑到用户的采用和平衡短期和长期目标。

A quality management system (QMS) provides businesses with a systematic approach to continuous improvement of key quality processes including document management, audits, inspections, complaints handling, CAPA and RCA, equipment management, risk management, management reviews, etc.

优质管理系统（QMS）为企业提供了一种系统化的方法，持续改善关键的优质流程，包括文件管理、审计、检查、投诉处理、CAPA和RCA、设备管理、风险管理、管理评审等。

Introduction 介绍

Over the years, McKinsey has conducted some wonderful research on'Why Most Transformations Fail?’ Here are a few key takeaways from the study:

多年来，麦肯锡对“为什么大多数转型失败？”进行了一些精彩的研究。以下是该研究的几个关键要点：

1. Over 70% of transformations fail and one of the major reasons is lack of organization-wide buy-in to bring about change

2. Often, companies don’t invest in upgrading the skills and capabilities to make a transformation successful

3. People are often busy with “current” tasks that they don’t have the time for“transformative” tasks

4. Most transformations are not aspirational enough and the decision-makers don’t take the effort to bring in the conviction to bring about change

5. 超过70%的转型失败的主要原因之一是缺乏组织全员的认同以实现变革

6. 通常，公司不会投资于提升技能和能力，以使转型成功

7. 人们通常忙于“当前”任务，没有时间处理“变革性”任务

8. 大多数转型目标不够有抱负，并且决策者并没有付出努力去带来变革的决心

While the above points are relevant for any kind of transformation, it is certainly relevant for quality management teams. Quality leaders, in several cases, look to embrace digital transformation and automation to “solve an immediate problem” or “speed up a particular process”. They would say, I need to accelerate the process of complaints handling or I need a modern EQMS Software to handle audits and inspections. But, it would be a mistake to focus only on the short-term requirement.

尽管以上观点适用于任何类型的转型，但对于质量管理团队来说尤为重要。在许多情况下，质量领导者希望采用数字化转型和自动化来“解决即时问题”或“加快特定流程”。他们可能会说，我需要加快投诉处理流程，或者我需要一款现代化的EQMS软件来处理审计和检查。然而，将重点仅放在短期需求上是错误的。

The QMS Implementation Roadmap QMS实施路线图

Real, effective transformation happens when there is a clear roadmap with timelines to bring about change. Quality teams must draft a quality strategy document with digital transformation at the core.

真正有效的转型发生在有明确时间表的清晰路线图指引下。优质团队必须起草一份以数字化转型为核心的优质战略文件。

This QMS Strategy Document must include the following:

这份QMS战略文件必须包括以下内容：

1. Quality and transformation goals

2. Roadmap for QMS Implementation with priorities/dates

3.     Cover key processes to automate (and modules to implement)

4. Key factors to consider while choosing an EQMS software

5. Quality metrics to track

6. Common pitfalls and challenges

7. What does it take to ensure customer success?

8.     Ease of implementation

9.     User adoption

10.     Data-driven process for

11.     Continuous Improvement

12.     Key people on the customer side who’ll enable the transformation

13.     Integration with other business systems

14. 优质和转型目标

15. 实施QMS的路线图，包括优先级/日期

16.     涵盖自动化的关键流程（以及要实施的模块）

17. 选择EQMS软件时需要考虑的关键因素

18. 需要跟踪的优质指标

19. 常见的陷阱和挑战

20. 如何确保客户成功？

21.     易于实施

22.     用户采用

23.     数据驱动的流程

24.     持续改进

25.     能够推动转型的客户方的重要人物

26. 与其他企业系统的集成

A quality management system (QMS) provides businesses with a systematic approach to continuous improvement of key quality processes including document management, audits, inspections, complaints handling, CAPA and RCA, equipment management, risk management, management reviews, etc.

优质管理系统（QMS）为企业提供了一种系统化的方法，持续改善关键的优质流程，包括文件管理、审计、检查、投诉处理、CAPA和RCA、设备管理、风险管理、管理评审等。

A well-implemented QMS will have a direct impact on QCD – Quality, Cost & Delivery. It’ll have a direct impact on business and financial performance – by lowering costs, increasing operational efficiency and delivering quality products/services to customers. Needless to add, it’ll make the process of regulatory compliance simpler.

一个良好实施的QMS将直接影响到优质、成本和交付（QCD）。它将对企业和财务绩效产生直接影响——降低成本、提高运营效率并向客户交付优质产品/服务。不用多说，它还会简化合规流程。