June’s Midwest Discussion Group (MWDG) continued the CAPA discussion. We had a great turn out with four newcomers. Some of the highlights are listed below:
Topic: Does your company analyze the following? If they are, how? (a) processes, (b) work operations, (c) concessions, (d) quality audits, (e) records, (f) complaints
Group 1: The consensus was that all our companies look at each are. The challenge becomes who is involved and their perspective.
Group 2: Incoming supplier product quality via rejects. Work operations via scrap and complaints. Quality audits via audit findings. Record via audits.
Group 3: Processes: Metrics and reaction plans are required. The Quality function usually owns process control, but others should be involved. A cross-functional business review should drive process design and adoption.
Topic: What tools / approach does your company use to conduct root cause? Are they conducting root cause?
Group 1: Common tools are “5 whys” and process review. There is too much emphasis on solving it fast than thorougly. Sometimes companies focus on: the convenient cause instead of the root cause and jump to corrective action without root cause.
Group 2: Fisbone, brainstorming, pareto, is / is not, colored hat approach, data analysis and control charts, cross-functional team input.
Group 3: No single tool will lead to the root cause. Good judgement and knowledge are always required. The knowledge of many is greater than the few or the one.
Topic: Does your company take a risk-based approach to determine if a CAPA or trending is needed?
Group 1: The risk assessment process is a great help to determine entry into CAPA system and will help prevent over using CAPA.
Group 2: Use a “gateway” approach that ranks quality issue by safety, cost, and frequency.
Group 3: Yes.
Topic: How does your company check for effectiveness? How is it determined to be effective? When do you check it? What tools do you use?
Group 1: We noted a critical step in determining effectiveness is to build the parameters of measurement for effectiveness during the initial CAPA process.
Group 2: Check for reoccurrence. The problem defines what metric is tracked and for how long.
Group 3: Look for reoccurrences over a reasonable time period.
The group was very excited and the discussions were great! We also added some time to actually network and meet one another.
Check out a few links that were recommended that pertain to root cause analysis:
http://www.hss.energy.gov/NuclearSafety/techstds. . .
- Not medical device specific but a good resource for conducting a root cause analysis
http://www.criticalthinking.org/
http://www.asq.org/quality-press/display-item/index.html . . .
The next meeting is July 26, 2007 and will conclude the series on CAPA. MWDG plans to publish a white paper or some other document that provides an overview of the CAPA sessions.
