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8 Essential Skills For Effective CAPA Management

gerenciamento de CAPAs

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edilainecrist
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29 views10 pages

8 Essential Skills For Effective CAPA Management

gerenciamento de CAPAs

Uploaded by

edilainecrist
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd
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8 essential skills for effective CAPA management Combine these skills to effectively identify root causes, develop approriate actions and ensure successful implementation Master Regulatory Knowledge ¢ Understand regulations like 21 CFR Part 820 and standards like ISO 13485 by reading the full text ¢ Attend training sessions, webinars, and workshops offered by regulatory bodies or training organizations ¢ Apply your knowledge in real-world scenarios like mock audits to identify gaps and areas for — > Georg Digel Italk about CAPA improvement Develop OMS Expertise ¢ Learn to create structured, manageable QMS documentation with focus on clear procedures rather than complex documents * Become good in conducting gap analyses to identify deviations and areas for improvement ¢ Develop cross-functional knowledge to understand how QMS integrates with business processes and departments Georg Digel Italk about CAPA Improve Root Cause Analysis Techniques © Avoid blaming individuals and instead look at systemic issues and process failures that allowed the problem to occur ¢ Follow a systematic methodology like Fishbone Diagram or Failure Tree Analysis to dig deeper into causes ¢ Include people from different roles for varied a? eae Italk about CAPA insights to overcome individual biases Enhance Data Analysis Skills ¢ Ensure you have a solid understanding of statistical concepts, data cleaning techniques, and basic analysis methods ¢ Practice breaking down complex problems into manageable components ¢ Understand the field you're analyzing data for to ask the right questions a? eae Italk about CAPA Improve Documentation Skills ¢ Learn established documentation standards and techniques (Tip - Google's Technical Writing course is a great free resource to start with) ¢ Practice writing clear, concise explanations without unnecessary jargon and use short sentences ¢ Organize information in a logical flow, using headings, lists, and other formatting to improve readability —) Georg Digel Italk about CAPA Strengthen Risk Management Skills ¢ Learn ISO 14971 for how to assess and mitigate risks with the goal to identify and control potential hazards in your processes ¢ Utilize data and analytics to support risk assessments and inform decision-making ¢ Use tools like risk matrices to assess and prioritize risks based on their potential impact — > Georg Digel Italk about CAPA and likelinood Cultivate Critical Thinking and Communication ¢ Start the habit of asking questions that challenge assumptions and dig deeper into ISSIU(o} ¢ Stop taking things for granted and consider different viewpoints and interpretations of Halcolanircl ecole} ¢ Communicate information effectively and engage with various stakeholders to implement solutions ——) eae Italk about CAPA Foster Teamwork and I erteConayie * Clearly define and communicate each team member's role and responsibilities to reduce confusion on how they contribute * Create an environment where team members feel comfortable sharing ideas, giving feedback, and voicing concerns ¢ Model the behaviors you want to see in your team like a strong work ethic, positive attitude, and commitment to the team's goals ——) eae Italk about CAPA © Hi, I’m Georg. I talk about CAPA in MedTech Follow for insights on: c

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