PRODUCT COMPLIANCE CULTURE

Any business making or selling products has product compliance risk. A missed regulatory requirement or customer specification? A dimension that falls short of internal expectations? What matters most is what happens next.

Some companies approach the issues proactively, with rigorous factual investigation, root cause analysis, and prompt corrective action. Other companies cover up the problem. The difference is culture. Companies that insist truth be spoken to power cultivate a culture of integrity. Employees learn to address problems early.

We introduce priceless lessons learned, distilled from inside the biggest product compliance cases in history. This encourages integrity culture, and is the best way to avoid and mitigate product compliance issues.

BETTER SAFER PRODUCTS

Manufacturing is complex. Sometimes things go wrong, that is just part of business. But as a manufacturer you try to minimize product safety problems.

The only thing worse than a product safety problem, is seeing the same problem again a year after you thought you eliminated it. When problems occur, you need to learn from them. We help you capture “lessons learned” and bake them into your design and manufacturing processes.

Big problems are solved with focus, discipline and small bites. From product integrity and compliance, to requirements engineering, we apply legal acumen and engineering process tools to craft long term solutions to your worst problems.

BUSINESS PROCESS MAPPING

Processes are critical to business. Product safety & integrity are best managed through an integrated framework of processes.

Well mapped processes give clear insight into key business activities, and help reduce waste. Tracking actual work against a process map makes audit easy.

We’ve assisted some of the world’s most sophisticated businesses with documentation and harmonization of common-sense processes for “requirements engineering,” structured problem-solving, escalation, lessons learned, record retention, compliance, audit, and more.

INTEGRATED COMPLIANCE SOLUTIONS

We’re not going to tell you that product safety solutions are easy, quick, or available out of a box. The best solution to your problem will be based on your product development DNA. The best long term solutions to product safety problems deliver maximum impact with minimum business disruption.

We understand developing and implementing a successful solution for your R&D, procurement, manufacturing, or distribution departments requires the integration of your people, your processes, and your technology.

We deliver compliance solutions that integrate into existing client business processes. This means engaging R&D, design, procurement, project management, engineering, finance, legal, compliance, and risk management.

We help our clients stay focused on their core businesses.

RECALL & LITIGATION RISK REDUCTION

No one wants to recall a product. But sometimes that is the best option.

If a recall is necessary, make sure you get it right the first time. Underestimating recall scope rarely works out well. Over estimating recall scope is throwing away money and unnecessarily disturbing your customers. You need properly scope the recall, and convince your customers and regulators. We’re experts at the coordination necessary to get this right.

Recalls drive product liability litigation and recall documents complicate existing litigation. From the design stage forward, we help mitigate the impact of recalls on litigation. We’re experts at efficient litigation. We help coordinate design, engineering, quality, comms, legal, insurance, and outside counsel. Use your legal spend wisely.

COMPLIANCE ADVISORY SERVICES

We coordinate with our clients wherever it will have the most impact. Sometimes that means observing and listening to employees on the assembly line.

Other times it is necessary to involve the plant managers. Or we may meet talk with management about breaking down vertical barriers to communication.

Ultimately, when it comes to culture, it is essential to engage the C-Suite in clarifying and communicating tone-at-the-top.

That’s LegalKaizen.

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