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CAPA 晃进酒吧...
出自识林
CAPA 晃进酒吧...
2025-11-22
*以下小文来自检查专家Ian Thrussell先生分享，翻译供识林读者轻松一刻
CAPA walks into a bar.
The bartender sighs and says, "You again?"
CAPA晃进酒吧。
酒保叹气：“又是您呐？”
In pharma, that line isn't a joke,
it's our Tuesday.
在制药圈，这可不是段子，
是家常便饭。
We laugh because we've all been there.
The same deviations.
The same investigations.
The same fixes.
我们会心一笑，因为都经历过。
同样的偏差，
同样的调查，
同样的补丁。
Different day, same root cause,
just wearing a new disguise.
日子在变，根因不变，
无非换件新马甲。
In most organizations, the issue isn't that people fail.
It's that systems learn slowly.
多数企业的问题不在人员失误，
而在整个体系学得太慢。
And sometimes we put our effort in the wrong place:
有时我们还使错了劲：
We "fix" the SOP so yesterday's deviation isn't one tomorrow.
Valid sometimes, but if overdone, it dilutes control.
给SOP“打补丁”，给旧偏差“转正”——偶尔有效，但过度使用就会导致失控。
We treat on-the-fly workarounds as comments instead of signals.
临时变通成了轻描淡写，而非警报信号。
We chase metrics over meaning,
making "low deviations" a goal instead of a reflection of culture.
追逐指标胜过实质，
让“低偏差率”成目标，而非文化写照。
We label everything as critical
and then nothing gets the focus it needs.
事事标榜“关键”，
事事丢失焦点。
We rush investigations,
or assign them without the right expertise.
调查仓促收场，
或交给门外汉担当。
We let stalled CAPAs stay buried,
no trigger, no time, no clear escalation.
放任CAPA石沉大海，
无触发、无时限、无上报路径。
None of this stems from malice.
It's fatigue.
It's bandwidth.
It's incentives, misaligned.
这一切无关恶意，
而是疲惫蔓延，
精力见底，
激励跑偏。
And the result?
Recurrent lessons — unlearned.
结果如何？
教训轮回——未成镜鉴。
CAPA maturity begins with a better question:
Not "How fast can we close this?"
But "What is this trying to teach us?"
CAPA成熟度始于换个问法：
不问“多快能结案？”
要问“它想教我们什么？”
That's where leadership matters.
这时才见真领导力。
Leaders shape the conditions for learning:
- They protect time and space for deep dives
- They ensure definitions and expertise are clear
- They align metrics with transparency
- They set the environment to surface tough truths
领导者营造学习土壤：
Every CAPA is a mirror.
The question is:
Do we use it to see ourselves
or just to check the box?
每份CAPA都是明镜，
关键在于：
我们用它照见本质，
还是仅仅打钩完事？
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