编者按: 这是罗恩李尔王关于能力和性能的系列博客的第2部分. 阅读第1部分 在这里.
小问题主题- 性能vs合规性把这部1979年的电影命名为关于表演的电影，并说出问试镜问题的演员的名字. Note that the name of the character (not actor’s name) has been changed to add another trivia question and not give away the answer. 对于额外的“罗恩·巴克斯”或分数，使用别名“布罗迪”对. 电影中真实角色的名字?
布罗迪:你进去了 交通堵塞?
有希望的演员:是的，先生
布罗迪:谁是导演 交通堵塞?
充满希望的演员:是你，先生. 布罗迪
布罗迪:哦. 我怎么样??
充满希望的演员:太棒了.
布罗迪:谁是编舞?
充满希望的演员:是你，先生. 布罗迪.
布罗迪:我怎么样?
充满希望的演员:太棒了.
布罗迪:你就是这样找到工作的.
小问题:说出这部电影和提出试镜问题的演员的名字.
琐事规则:运用你的大脑、记忆力和推理能力来解决这些问题. 谷歌，IMDB等.
以基于成熟度级别的法规遵循框架为例. The intention and design of these frameworks is that compliance can be boiled down to a single number, e.g. maturity level 3, which theoretically then equates to certain demonstrable performance expectations. But unless those maturity levels are calibrated through some level of performance benchmarking requirements, 规范, 目标和可测量的结果, they quickly become meaningless and can promote a “race to the bottom” to check the compliance box and then go back to business as usual. This “one and done” approach is also dangerous and risky because of the increasingly rapid changes in the world, 科技与商业. 它还有效地忽视了绩效改进和创新的需要.
缺乏抽象成熟度级别之间的确证或相关性, 不管它们的定义有多好, 成熟度等级毫无意义, and that has NOT escaped the notice of US Department of Defense officials who require and use CMMI maturity level ratings in their RFPs. 他们想听什么就说什么. 布罗迪，也许一开始会让他们得到这份工作，但这并不能保证他们有更好的表现. Focusing on continuously improving performance and outcomes does a much better job in terms of performance expectations and real results.
但别相信我的话. Here are examples of performance outcomes from nearly 100 organizations that recently adopted CMMI V2.0:
- “The CMMI journey has helped us develop a culture of process transformation with predictable delivery.(Wipro副总裁兼质量与澳门赌场官方下载风险管理全球主管)
- “The CMMI model taught us to think in favor of the customer and be very thorough in terms of delivering our development projects. 我们从一个任务到另一个任务，从一个决策到另一个决策，从一个项目到另一个项目，努力提高绩效.”
- 这些结果在19个不同的行业中也是一致的, 包括金融, 航空航天, 运输, 电信, 和更多的. 政府合同只是这19项中的一项，甚至还不是最大的.
- 80%的目标显示质量显著改善, 生产力, 成本绩效, 调度性能, 功能和过程依从性.
- 与质量相关的目标是绩效改进的最大目标领域, with significant reductions in delivered defects and increased work product quality and testing 有效性. 不仅质量性能提高了, but the ability to detect and prevent defects also improved consistently for those organizations that targeted this area.
- 来自最近的2021年3月CMMI评估, 摘自评估发起人, 同时也是公司的首席执行官
- 关于CMMI绩效报告, the sponsor mentioned that he thought it was one of the most valuable outputs of the appraisal process because it helped him to validate his organization’s business objectives and alignment to them from the objectives, 基线和模型.
- The Performance Report will now become part of the company's process assets and they will be maintaining it on a quarterly basis as their performance and data evolve.
- His primary motivation for being appraised against ML5 was to confirm if his company’s performance had increased compared with the last appraisal (ML3) - not to win contracts. 事实上, he told the lead appraiser that he’s already satisfied the barrier of entry for winning contracts by previously being appraised to ML3. In his words: “I’m doing this for me and my company; my customers didn’t ask for it.”
- 他的员工提出的任何改进建议都需要有统计分析的支持. 用他的话来说:“任何人都可以提出建议，但他们需要用数据来支持.”
- He has linked his company’s bonus system to the collection and analysis of quantitative and statistical techniques to encourage habit and persistence (sustained performance).
This need to shift from compliance-based thinking to continuous performance improvement was the lesson the US Food and Drug Administration (FDA) discovered and decided to tackle in 2011. The 研究 the FDA commissioned is very revealing on how a compliance-based audit approach did NOT yield the results they expected.
以下是其中的内容 2011年FDA研究 解释好问题和事实:
“These inputs uncovered several key facts about marketed medical devices as well as potential catalysts for quality improvement.
- Serious adverse event reports related to medical device use have outpaced industry growth by 8% per annum since 2001.
- 质量风险在整个行业中并不是均匀分布的. 这反映了设备、制造商和使用环境的异质性和复杂性. 心血管, in vitro diagnostic (IVD) and general hospital/surgical devices account for nearly 60% of adverse events reports. 只有20个,189 active product codes account for 65% of all serious adverse events reports between 2005 and 2009.
- An analysis of root cause data reveals that failures in product design and manufacturing process control caused more than half of all product recalls. 质量问题的根本原因与设备类型密切相关. 治疗区域并不是回忆根本原因的有力预测因子.”
简而言之, 20-30 years of FDA regulations and the resulting compliance audits did not prevent medical devices from failing.
基于此 研究, 食品和药物管理局决定转向基于性能的, 持续改进方法, 有四个主要目标和衡量标准，包括安全, 有效性, 可靠性和可用性. The Case for Quality 自愿改善计划 (CfQ VIP or VIP) is a collaborative initiative between FDA CDRH, MDIC, ISACA, 还有医疗器械行业. This program was developed with the intention to elevate medical device stakeholders from the established standard of regulatory compliance to advancing medical device quality and safety through sustained and predictive practices that achieve better patient outcomes.
VIP利用 医疗器械发现鉴定计划(MDDAP), 哪个是ISACA CMMI框架的定制版本, as a model and appraisal method by which medical device organizations can measure their capability to manufacture high quality devices. FDA CDRH has adjusted the engagement activities and submission requirements for VIP participants in recognition of completing this independent assessment and committing to continuous improvement in an effort to support their individual improvement journeys and reach industry goals such as:
The tailored version of the ISACA CMMI framework used by the FDA and VIP is based on the CMMI Version 2.0，于2018年发布. 鉴于FDA的持续成功和这些前100家公司采用CMMI V2的结果.0引出一个不可避免的结论: 采用CMMI V2的组织的绩效结果.0清晰、一致和引人注目 如此如此, that the US Air Force is currently working on a continuous performance improvement initiative using CMMI V2.0类似于MDDAP程序. 请在以后的博客中关注更多相关内容.
