PathWise Blog

Posts Tagged ‘investigations’

What Percentage of Your Quality Investigations are Repeats?

Monday, June 7th, 2010

Repeat CAPA investigations are arguably one of the largest areas of concern for Life Science organizations today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as up to 30% of all open investigations- or 1 in every 3.

What percentage of your quality system investigations are repeats?

Vote at http://www.surveymonkey.com/s/89X2LM3

Effective Investigations: The Importance of Fact Gathering.

Tuesday, March 23rd, 2010

Last month, we talked about demystifying the root cause process- specifically with respect to the problem statement. The key takeaway from that clip was that you should take the necessary steps to fully understand the problem statement before investigating it.

This month, we’ll discuss the importance of fact gathering and common issues that get in the way of good investigations. Specifically:

  • Not enough questions.

  • Not challenging those with the information.
  • Not being thorough enough.
  • I see many investigators who don’t want to appear like they mistrust their witnesses. So they don’t challenge the meaning of words, and they often accept vague or general statements. They attach a meaning to the words and move on.

    My advice: Don’t be afraid to ask the “stupid questions.” For example, a witness may say “The truck was late.” I can either write that down and move on or I can ask “How late” or “What do you mean by late?” or “Whose truck?” By challenging, I get more concrete information. Remember, challenging helps us to be thorough.
    Also, make sure you’ve talked to all the witnesses. Gather all information using the necessary quality tools: checksheets, run charts, process maps, etc. I see too many investigations that are shallow because the investigator quits too early and in doing so, never identifies the root cause.

    Fact gathering means all the facts- leaving no stone unturned.

    Have you ever experienced this scenario while training a group? Please share your experience with us.

    What are the key elements of a sound CAPA System?

    Tuesday, September 15th, 2009

    CAPA is a critical quality subsystem that, when executed correctly, can provide an organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency. Yet many organizations struggle with CAPA, from ongoing and repeat investigations to lack of management control.

    A CAPA System itself must be compliant, effective and efficient. But how do we get there? What elements do you consider to be essential to creating a sound CAPA System?

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