Managing the Audit Function in a Global Company

Duration: 60 Minutes
The audit function can be a priceless resource for a global company provided this function has the breadth and depth of critical thinking skills, experience, and quality systems, risk-management, and regulatory know-how to view audits in their proper context and offer the appropriate inputs as part of a comprehensive program of improvement.
Audit Function in a Global Company
Instructor: Jose Ignacio Mora
Product ID: 509066
Audits by themselves are simple inputs to identify non-conformances and deficiencies. Complex issues require independent examination and unique problem-solving skills. Employees and functions with this role typically report to executive management since their recommendations must cross various functional and departmental boundaries.

Too often, companies default to habits and procedures and this can result in wrong decisions and, at times, fatal results.

Objectives of the Presentation
  • Fundamentals of Auditing
  • Auditors and organizations
  • Auditors and reporting relationships in complex companies
  • The mission of corporate departments
  • Goal: independent experts that support effective problem-solving
  • Examples, issues, and outcomes
  • The growing need for corporate problem-solvers
Why Should you Attend
This presentation focuses on the role, skills, organizational opportunities, and the benefits of an independent audit group to advise senior management on the true causes of complex situations. Although the typical setting would be in larger multi-national companies, this role can be sized to meet the needs of all companies, especially when the situations will cross national, divisional, and organizational boundaries.

Such a group must be properly vetted and staffed with the proper mix of experience, critical thinking skills, and be able to think and act with a holistic view of the situations they handle. This is especially critical to avoid group-think and to also properly assess and advise senior management.

Who will Benefit
Managers, Directors, and Vice-Presidents in the areas of:
  • R&D
  • Manufacturing Engineering
  • Design Assurance
  • Quality Assurance
  • Operations
  • Document Control
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Instructor Profile:
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.

During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa's business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis' first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.

During his time at Cordis, Jose managed the Maintenance and Facilities Department, taking that operation to a level rated as "tops" by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose's leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
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