Effectively clarifying deviations and prioritizing them allows investigators to assemble appropriate teams and apply appropriate methods to conduct effective and compliant investigations.
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.
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 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.
Organizations achieve greater impact by developing analytic skills broadly across their workforce and using technology and systems that support a transparent compliance process.
Instead of limiting quality efforts to specialized teams, expanding the focus on quality across the organization improves responses to compliance issues while supporting a broader, proactive approach to continuous improvement.
The site managers at a global biopharmaceutical company explored opportunities to reduce the number of investigations as well as the number of days required to close their investigations. The plant did not have a standard, systematic approach to finding the root cause of manufacturing deviations.
Reduction in required investigations
Closings dropped by this amount, compared with the previous year
The plan to improve the investigation process and incorporate KT as the investigation methodology was completely developed and implemented in less than six months.
Gerresheimer manufactures specialty glass and plastic products that support the highly regulated pharmaceutical and healthcare industries. Issues arose as the result of a material adjustment - a component made of a soft plastic material had to be changed to a comparable material when the existing one was no longer available. Testing required that a significant amount of product had to be quarantined, because product made with the new material did not meet the specification.
saved
The application of KT process yielded significant results beyond the hundreds of thousands of Euros saved when the quarantined batches were released and shipped to the customer. Most importantly, product safety was ensured. The use of KT analysis and the confirmed root cause helped Gerresheimer to eliminate any risk to end-use customers and avoided the potential for recalls of product already on the market.
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