Root Cause Investigation for CAPA

Weaver Consulting provides training and facilitation to conduct a root cause investigation (root cause analysis or RCA) using a systematic, science-based, investigation methodology when there has been a change in the performance of a product, work process, system, machine, or equipment.

When Is This Methodology Used?

It is ideal for investigating:

• CAPA (corrective action / preventive action) issues,
• technical problems,
• increased product or service defect levels,
• increased customer complaints,
• increased negative customer or patient reactions with the product,
• increased manufacturing scrap or rework,
• equipment or process aberrations, or
• any performance change where an investigation is required.

Why Our Methodology?

We have incorporated excellent investigation techniques and tools from many sources into a single, straightforward methodology. Our approach integrates problem solving techniques from total quality management (TQM), Six Sigma, and generic problem solving methods to identify the change that has occurred (the technical root cause) as well as any system failures that allowed the change to occur (systemic root causes). Corrective and preventive actions are then taken so that performance can be restored. A control plan is then implemented to prevent the problem from ever returning.

The framework for our methodology 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 in situations where there has been a change in the performance of a product, process, machine, or equipment.

Why Turn To Us?

• 30+ years of experience in both conducting investigations and teaching this methodology effectively in the healthcare products industry.
• We understand the industry and the issues you face.
• We have provided training & facilitation to over 50 global companies on 5 continents.
• Our training uses real case studies and multiple workshops to immediately engage and excite the participants.
• Your people will learn & develop the skill sets to immediately & successfully tackle serious investigations upon returning to work.

What's The Bottom Line?

As a result of the Root Cause Investigation for CAPA, you will:

• successfully identify and eliminate root causes,
• eliminate their associated extra costs,
• save valuable time & resources by conducting effective & efficient investigations,
• and because you will be eliminating both technical and systemic root causes, the number of similar investigations will decrease dramatically!

Does This Really Work?

A few years ago a medical products plant had a problem with its sterilization process. The potential cost was in excess of $2 million. The plant began the investigation using the traditional approach. Six weeks passed and no progress had been made while the 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 were conducted that identified 3 root causes. Solutions were identified and a control plan implemented to prevent reoccurrence.

The results: The potential loss was 100% averted. The problem was resolved and has never returned.

Need More Information or a Quote?

Telephone

Country Code for outside the U.S.: 001

Phone Number: 847-846-2072

E-Mail

info@weaverconsulting.biz