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QMS实施最佳实践:规划采用至关重要(四)

 Akso质量管理 2024-01-31 发布于重庆

To ensure your QMS Implementation Program is successful, keep in mind the following:
为确保您的质量管理体系(QMS)实施计划成功,请记住以下几点:

  • It’s a long-term journey of user adoption. Plan for it!

  • The QMS has to become an integral part of day-to-day operations. It has to integrate with the ERP and CRM, and a cultural shift is needed where all quality-related processes and decision-making happen through the EQMS Software.

  • Right from the early days, involve various stakeholders. Configure it to show immediate business value in the short-term.

  • Keep driving enhancements and improvements. QMS Implementation is not a one-off project.

  • Implementing a flexible, scalable QMS that can be configured as per your business process is important.

  • Track quality metrics and showcase the value and impact of the digital transformation effort.

  • 这是一个长期的用户采用过程,要提前计划!

  • QMS必须成为日常运营的一部分。它必须与企业资源计划(ERP)和客户关系管理(CRM)集成,并需要进行文化转变,所有与质量相关的过程和决策都通过EQMS软件进行。

  • 从早期开始,涉及各方利益相关者。在短期内进行配置,展示即时的商业价值。

  • 不断推动改进和提升。QMS实施不是一次性项目。

  • 实施灵活、可扩展的QMS,可以根据您的业务流程进行配置,非常重要。

  • 跟踪质量指标,并展示数字化转型工作的价值和影响。


5 Key Best Practices for Effective & Efficient QMS Implementations 实施和高效QMS的5个关键最佳实践

  • QMS Implementation & Strategy Workshop with Key Stakeholders 与关键利益相关者进行的QMS实施和战略研讨会

  • Robust Testing with 'Real Users’ Before Deployment 部署前与“真实用户”进行强大的测试

  • Data Migration Made Easy 简化数据迁移

  • Agile Approach 敏捷方法

  • Training & User Adoption 培训和用户采用



一、Implementation Stories –From a Large Enterprise and an SMB 大型企业和中小型企业的实施案例

(一)Implementing ComplianceQuest EQMS at a Large Pharma Company 在一家大型制药公司实施ComplianceQuest EQMS

A pharma major purchased the ComplianceQuest QMS for its features but also wanted some customizations to the software to suit their specific needs. Our team began with a walkthrough of the software and gathering a high-level understanding of customer expectations.
一家制药巨头购买了ComplianceQuest QMS,因为它具备一些功能,但也希望对软件进行一些定制,以适应其特定需求。

A prototype was developed based on these requirements and demonstrated to the customer, helping them visualize how their processes would be impacted. These were further broken down and the 200-300 requirements that came up were converted into bite-sized modules after vetting each of them.
我们的团队首先对软件进行了演示,并获取了对客户期望的高级了解。根据这些需求开发了一个原型,并向客户演示,帮助他们想象他们的流程会受到哪些影响。这些需求进一步细化,并且在经过审查后,将提出的200-300个需求转化为可分解的模块。

Once the requirements were finalized, configuration sprints began once every two weeks. In each sprint, the configurations were tested by actual users. Once that was approved at the first stage of testing, a bigger team did a business scenario testing and the feedback went into another iteration of the sprint for bug fixing. Parallelly, a data team managed the migration of hundreds and thousands of data sets. The customers also had their own technical and data teams working with the CQ team to aid and assist the respective CQ teams. The involvement of the management and regular training of the customer teams contributed to making the implementation a success. They were live in a year’s time.
一旦需求确定下来,配置就每两周进行一次冲刺。在每个冲刺中,实际用户测试配置。一旦在第一阶段的测试中获得批准,更大的团队就会进行业务场景测试,反馈意见进入另一个迭代中以修复错误。与此同时,一个数据团队管理着数以千计的数据集的迁移。客户还与CQ团队一起工作,协助相关的CQ团队进行技术和数据方面的支持。管理层的参与和对客户团队的定期培训有助于使实施工作成功。他们在一年的时间内开始正式使用系统。

(二)Implementation at an SMB 中小企业的实施
For an SMB, ComplianceQuest did an out-of-the-box implementation. The customer wanted to go live in 30 days since an audit was coming up and they wanted to show they were on a different QMS system. Here too the management was on board to get this live and no requirements for change were entertained.

对于中小型企业而言,ComplianceQuest进行了即插即用的实施。由于即将进行审计,并且客户希望展示他们采用了一种不同的质量管理系统,他们希望在30天内上线。在这里,管理层也积极参与,努力确保项目的顺利进行,并且没有考虑进行任何需求变更。

This was possible because the customers were open to changing some of their processes to meet the software’s functionality. In this case, they went live with the audit module. Normally, smaller clients opt for two to three modules at a time and it can take anywhere from two to three months to complete the deployment.

这是可能的,因为客户愿意改变一些流程以满足软件的功能。在这种情况下,他们启用了审计模块。通常,较小的客户选择两到三个模块,并且完成部署需要两到三个月的时间。


二、QMS Implementation: Common Challenges and Pitfalls QMS实施:常见挑战和陷阱
There are some common factors that affect the speed and effectiveness of implementing a QMS. These include,

有一些常见因素会影响QMS实施的速度和效果。其中包括:

Changing the Mindset: One of the main challenges is when businesses want to change the software to suit their processes rather than adapting to the software functionality. For instance, customers want to name their documents in a particular way. Today, with meta tags, traditional file naming is not required as search has become more refined. Therefore, aligning the process with the software can provide many benefits. Businesses must be able to see the value in changing their processes for greater efficiency and using the software the way it was designed.

改变心态:一个主要挑战是企业希望根据其流程来改变软件,而不是适应软件功能。例如,客户希望以特定方式命名其文档。如今,随着元标签的出现,传统的文件命名不再必要,因为搜索已变得更加精细。因此,将流程与软件对齐可以带来许多好处。企业必须能够看到为了提高效率而改变其流程并使用软件的价值所在。

Delayed Deployment: This needs for changing the software can push the timelines significantly. Customization requires identifying the current practices, identifying the gaps between the functionality and the requirement, and making suitable changes. These change requests need to be gathered first and then the changes made. The changes have to be tested satisfactorily before deployment. Therefore, this can be one major reason for the delay.

延迟的部署:这需要改变软件的需求,可能会显著推迟时间表。定制化需要识别当前的实践,找出功能和需求之间的差距,并进行相应的更改。这些变更请求首先需要收集,然后进行更改。更改必须经过令人满意的测试才能部署。因此,这可能是延迟的一个主要原因。

Technical Experience: In a project where technical experience is more, the chances of it succeeding is more. Such teams understand the nuances of implementing an electronic system and can facilitate faster implementation. With less experience, there are many queries and fear of the unknown that can impact the speed of deployment.

技术经验:在一个技术经验更丰富的项目中,成功的机会更大。这样的团队了解实施电子系统的微妙之处,可以促进更快的实施。经验较少的情况下,可能会有很多疑问和对未知的恐惧,这可能会影响部署速度。

Everything is automated and fast; we can generate reports for information, strategic, and planning purposes, which makes a huge impact on our productivity and efficiency.

一切都是自动化和快速的;我们可以为信息、战略和规划目的生成报告,这对我们的生产力和效率产生了巨大的影响。

The support and communication at ComplianceQuest have been top-notch, even on days when there was a lot of pressure.

ComplianceQuest的支持和沟通工作非常出色,即使在压力很大的时候也是如此。

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