Corrective Action Programs
Keep production running
FDA requirements for quality, validations, complaints and recalls set high standards for compliance. To meet the challenges of operating in a regulated environment, systematic, analytical processes cut through the complexity of compliance, helping teams to set priorities, troubleshoot issues effectively, complete well-documented investigations and implement effective CAPAs. 
When advanced critical thinking processes are integrated into CAPA systems and software, teams not only improve compliance but ultimately reduce regulatory issues and their associated costs.
Integrate analytic thinking into processes, monitoring systems and software
An effective CAPA program begins with prioritizing relevant issues
Effectively clarifying deviations and prioritizing them allows investigators to assemble appropriate teams and apply appropriate methods to conduct effective and compliant investigations.
Training and facilitation can dramatically improve root cause analysis
Investigators capable of applying a systematic RCA process are better able to gather the data needed to find true cause efficiently, take effective action and establish effectiveness checks. This eliminates investing in expensive, unnecessary counter-measures and reduces recurring problems.
Eliminate distractions when the pressure to perform is high
A structured issue resolution process helps investigators focus and act rationally and constructively even in emergency situations. When risks or costs are high, following a structured analytic process helps investigators maintain momentum without distractions.
A common investigative approach prevents misunderstandings and builds confidence
A shared approach and language unites functions and eliminates the silos that can slow investigations. In addition, consistent documentation of the thinking behind compliance efforts provides clarity within the organization and for auditors.
Case Studies Section
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$11M
saved in the first year
60%
improvement in on-time performance
50%
reduction in admin workload
Challenges
Kennecott Utah Copper operates the Bingham canyon mine concentrator plant, a smelter and a refinery. Ore from this mine is concentrated into slurry, piped to where the smelting process occurs, and then sent to the refinery. Efficient operation at the concentrator stage is critical to maintaining uptime of the smelter. Each year the concentrator plant is shut down a total of 36 times. This is necessary to maintain critical equipment while essential repairs and upgrades are completed. The issue at Bingham was that the length of downtime was causing a bottleneck in the overall process.
Read Case StudyResults
The shutdown process saved over $11 million in the first year of implementation. On-time performance improved by 60% and is tracking towards world-class results. key performance Indicators (KPls) for shutdown performance improved over all prior years. Team performance (on-scope, on-cost) improved by 60%. Shutdown administrative work load fell by over 50% allowing team members to focus on other areas such as reducing cost or generating more revenue. All Injury Frequency Rate (AIFR) improved, advancing a strong safety culture which is a core value of KUCC.
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47%
improvement in operational efficiency
30%
improvement in production rate
50%
reduction in change over time
Challenges
After a major capital investment at its biscuit factory at Papakura, Griffin’s needed to address several variables impacting overall conversion cost. The site was struggling with high waste, high downtime, and planning deficiencies; and overall workflow was not conducive to producing at the lowest possible conversion cost.
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For overall results, Operational Efficiency (OE), the measure of line performance relative to a theoretical maximum achievable throughput rate, was used to measure success. To achieve an OE of 100%, the line must run at its maximum theoretical throughput rate with zero plant downtime and product waste. At the conclusion of the Kepner-Tregoe engagement the plant achieved:
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€4.5M
decrease in spin-off costs
70%
non-conformity reduction in 3 years in specific departments
Challenges
Fokker wanted to increase their issue resolution maturity. This meant improving the quality and completeness of information about problems, accelerating root cause analysis and involving the right people at the right time.
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Success has been measured in a drastic reduction in non-conformities which is saving millions of euros yearly. A proactive culture has replaced the “fire-fighting” of reactive problem solving.