At any given day, a manufacturing or production environment will experience a myriad of problems with different levels of risk or urgency. Determining which problems require further investigation and resolution is a challenge faced by many well-meaning managers. The good news, however, is that there are a few tried and true tools of the trade that may be used to help identify and focus on key problems that require quick resolution. The first tool is:
1. Pareto Chart
Pareto chart is a great tool to use when your goal is to focus in on the problems which offer the greatest potential for improvement. In its simplest form, a Pareto chart is a bar graph chart showing the relative frequencies of each issue under evaluation and showing the relative frequencies. Pareto charts will show you the relative importance of problems in a simple, easily interpreted and visual format. This tool is excellent in helping the team remain focused on issues with the greatest impact that will provide the highest yield. I like to say that it is the tool that shows you where you will receive the “biggest bang for your buck”.
Oftentimes, management can become so overwhelmed by the many issues plaguing their departments that they will put valuable resources (i.e., time, personnel and financial) on several insignificant issues while the more pressing issues remain untouched and unresolved. The Pareto principle states that “20% of the sources cause 80% of the problem”. Therefore, it is imperative that you have a methodology to evaluate the many problems facing the department and focusing in on the top 20% or even top 10% which causes 80% of your problems.
Next week’s blog, I will cover how to effectively perform a Pareto on a given problem. Happy Investigating!
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Good points. I would like to add that often, management does not understand the regulatory requirements or for what the FDA Inspector will be looking. This brings on undocumented process change and action, sign-off on documents when there is no objective evidence to support the issue, and similar issues. It is up to us, auditors, managers, engineers, and all whose names appear somewhere on the inspected document to push back and follow the SOP and not jeapordize the livelihood of all who work at a particular site not to mention the President ahd head of QA. More often than not, especially in a paper system, the temptation to back date documents to support a CA or place volumes of unrealted text to add volume to the support evidence is present. Maybe management needs training with regard to regulatory issues before the rush to a decision regarding an unrelated root casue. This might help redirect the resources, or at the very least, allow a memo-to-file to be generated to address those myriad issues that seem to pop up and get addressed while violating the QMS.
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