Solving Local Problems Globally
Root Cause Investigation for CAPA
Our Business
At Weaver Consulting root cause investigations are our sole business.
We focus and specialize in training and facilitation to conduct root cause investigations.
Our premier investigation process, Root Cause Investigation for CAPA, is a 7-step, systematic,
science based methodology to use when there has been a change in the performance of a product,
work process, system, machine or equipment.
The methodology identifies:
- Technical root causes (the changes that caused the performance deviation).
- Systemic root causes (system failures that allowed these changes to occur or failed to detect the changes).
- The appropriate corrective and/or preventive actions to restore performance.
- A control plan to monitor future performance to assure the problem does not reoccur.
What We Offer
We provide a complete package to assure your success including:
- The premier investigation methodology available today.
- In-depth training using workshops based upon real case studies.
- Powerful tools that make the application extremely practical.
- A roadmap that guides the investigator through the investigation and suggests the key tools to use and questions to ask.
- A procedure supporting the Root Cause Investigation for CAPA methodology that can be modified to meet an organization's needs.
- Electronic templates to further guide and thoroughly document the investigation.
- An executive overview providing management with a fundamental understanding of the investigation methodology and guidance on institutionalizing the methodology within the organization in order to obtain a quick return on the training investment.
- Facilitation services to assist an individual or team jump-start an investigation.
Why Weaver Consulting?
We have over 30 years of experience in both teaching and applying the investigation methodology effectively in the healthcare industry and 8 years of exposure to other industries.
We understand the healthcare industry and the issues you face.
We have provided training and facilitation services to over 50 companies in 24 countries on 5 continents.
Our training uses real case studies and numerous workshops to immediately engage and excite the participants.
Participants will learn and develop the skills to immediately and successfully tackle serious investigations.
With our training we provide a roadmap to guide the investigation and electronic templates to thoroughly document the investigation.
We guide the management team on how to institutionalize the investigation methodology within the organization.
What's The Bottom Line?
As a result of Root Cause Investigation for CAPA, your organization will:
• Successfully identify and eliminate root causes.
• Eliminate their associated extra costs.
• Save valuable time and resources by conducting effective and efficient investigations.
• And because you will be eliminating both technical and systemic root causes, over time the number of future investigations will decrease considerably.
When is the Methodology Used?
It is ideal for investigating:
• CAPA (corrective action / preventive action) issues.
• Technical problems.
• Increased customer complaints.
• Increased manufacturing scrap or rework.
• Equipment or process aberrations.
• Any performance change where an investigation is necessary.
Why Our Methodology?
Weaver Consulting has integrated exceptional investigation techniques and tools from multiple sources (including total quality management (TQM), Six Sigma, and generic problem solving approaches) into a single, straightforward methodology. The framework is an adaptation of the DMAIC (define, measure, analyze, improve control) process used by Six Sigma companies and is superior to DMAIC for restoring performance when that performance has deteriorated in a product, process, system, or machine.
The result is a methodology that is practical, easy to use, and gets results.
Does This Really Work?
A few years ago a medical products company had a problem with its sterilization process. The potential cost was in excess of $2 million. The plant initiated an investigation using the traditional approach. Six weeks passed and no progress had been made while costs continued to escalate!
Management pressure continued to mount. Finally, an engineer suggested the Root Cause Investigation for CAPA methodology. Management consented and within three days 53 possible causes were identified and all but 15 had been eliminated. At that point a few, focused experiments identified three root causes. Corrective actions were implemented along with a control plan to prevent reoccurrence.
The results: The potential loss was 100% averted. The issue was resolved and has never returned.
Need More Information or a Quote?
Contact Weaver Consulting
Telephone:
Country Code outside the U.S.: 001
Phone Number: 847-846-2072
E-mail:
info@weaverconsulting.biz