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Root Cause Analysis Tools

MJCross 22MAR2007

Applying RCA • Not always necessary • Focus on re-occurring and complex investigations • Different applications of RCA in CAM – UAM for Deviation .owner – Review of Operational Investigation – Participant in investigation team MJCross 22MAR2007 .

distilled cause of a problem resulting in a clear path to the corrective actions necessary to eliminate it .RCA .Definition • A structured.Most of the time it’s not the obvious answer . focused investigation that is conducted to identify the true. RCA takes work! MJCross 22MAR2007 .Need to be objective . contra to status-quo.Sometimes asking right questions is tough.

Successful RCA Components Requires… • A well defined problem statement…drill to the null • Need accurate info and data…no assumptions • Willingness to face the facts • A solid toolbox to aid in the investigation • Management buy-in and commitment • Practice. MJCross 22MAR2007 . Practice…. Practice.

mayo. fridge. produce.RCA – First Steps • Ask if this issue warrants a true Root Cause Analysis? • Example: If the sandwich shop you visit recently sold you a bad meatball sub. do you pursue resolution or just go to Subway? Hint: Always look-out for re-occurring problem…may not be the sub shop. the water. could be.electric company… MJCross 22MAR2007 .

Tools for Root Cause Analysis • Tools are Designed to: – Efficiently eliminate false investigative paths – Provide a common process to standardize issue review and resolution – Facilitate free thought while driving to true root cause and issue identification – Organized approach to discussions allowing logical analysis with traceable results MJCross 22MAR2007 .

Review of the popular tools… • Brainstorming – Great for small to larger teams…not too large – Structured free-thought to saturate a discussion and expose all investigative avenues – Can be combined with other tools such as Fishbone diagram or Process Flow review – Requires a strong leader. time – Watch out for bullies and know when to Quit – Brainstorming is most common tool used MJCross 22MAR2007 . open minds & experienced team. no bias.

) • Fishbone (Ishikawa) Diagram – Preferred for more complex investigations – Used to structure brainstorming sessions and focus on standardized categories of root cause areas – 6 Ms: Machine. Methods. Mgt MJCross 22MAR2007 . Process. Measurement. Man Or…Resources. Materials.Review of the popular tools …(cont. People. Mother Nature (Environment).

) • Called a Fishbone due to common set-up • Each Family or Root is reviewed • Allows for structured means of documenting potential causes • Good fit for process failure investigations in biotech environment • Cam investigation templates model this outline (i. Methods.Review of the popular tools …(cont.e. Equipment.) Fishbone (cont. Materials. etc are standard report sections) MJCross 22MAR2007 .

Are there defined mgt systems? (i.Is there accountability and appropriate responsiblility? . check.Communication adequate .Is the process running in a state of control? . do.Is the training effective? .Adequate planning of resources and expectations .Are employees empowered to contribute to quality? .Adequate oversight? . plan.Are the test methods and in-process checks adequate? . act) Is the equipment appropriate? Facility design adequate? Right number of people? Equipment capacity? Capable? People allocated correctly? Problem People Process .Are people of the appropriate experience do perform assigned duties? .Are the procedures governing the process adequate? .Leadership and guideance available .Fishbone Diagram Management Resources - .Is continuos commiment practiced? MJCross 22MAR2007 .e.

Review of the popular tools …(cont.) • Repetitive Why Analysis – Effective for all applications – Most versatile – Allows for the reduction of issue to true root cause => Drive to the Null – Requires an accurate problem statement – Can be tricky in some instances. may mislead… MJCross 22MAR2007 .

don’t focus on just the situation at hand MJCross 22MAR2007 .) Repetitive Why Analysis – Requires training.Review of the popular tools…( you need to go further???? – Use Why or “…which was caused by…” – Resolve the system flaw. practice. and persistence – Quick litmus test for true root cause….

Applying some concepts • Micro not sampling new WFI valve site for ~ 10 Weeks • Mixer used in mfg uncalibrated for 4 years • Lost Avonex DS batches due to inadequate mixing at purification stages MJCross 22MAR2007 .

• Re-occurring warrants special attention • Don’t be shy about applying concepts • Investigation=RC=CAPA=Problem Elimination MJCross 22MAR2007 .MJC Takeaways • Practice…start thinking and applying RCA in everyday problem solving situations • Drive to the null….

Root Cause References • Introduction to Investigations and Root Cause Analysis (Lehecka Pratt Associates. 2000) • Problem Solving with Quality Tools for Sustained Improvement (Biogen/ASQ Collaboration. Debra Owens Instructor) • Root Cause Analysis: Improving Performance for Bottom-Line Results (Robert and Kenneth Latino) MJCross 22MAR2007 .