Managing The Audit Function In A Global Company
José 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. José 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, José 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 the 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.
Whether your company is small or large each should have at least one independent yet experienced individual or department that can be relied on to resolve issues from these and other perspectives: quality assurance, regulatory affairs, and corporate risk management.
While companies rely on audits to remain in compliance everyone is eventually faced with a complex issue that requires examination from an outsider with unique problem-solving skills. Employees in this role typically report to executive management and are driven by personal goals and a high level of external standards.
Companies in a typical “routine mode” will fail, sometimes fatally by not establishing, developing or creatively using independent experts who are still company employees.
The author has seen numerous instances where internal but independent problem-solvers can provide acute, accurate and perceptive analysis of culture-bound problems. Further, such employees provide additional resources on an as-needed basis and can be employed in numerous settings to strengthen, investigate or support problem resolutions. For example in today’s world of ongoing changes, the trained auditor can independently highlight the “macro” or longer-term trends such as outsourcing, the changes in regulatory strategies and even trends in employee training. From a different perspective specific issues such as drifts in FDA-mandated specifications, changes in product chemistries, the impact of vendor management, cyber security challenges, etc., may all be bound to business practices and resistant to all but executive-mandated changes.
This type of broad-spectrum analysis is routinely needed in regulated industries and it is incumbent on organizations to creatively envision and develop talent to evaluate technical, macro and micro issues as required.
FDA and worldwide health authorities require that compliance and quality system audits be performed and those audits need to comply with: (1) Company guidelines, (2) Applicable consensus standards, (3) Domestic and international product-specific requirements, and, (4) Country-specific regulations.
Larger companies have more complex organizations with as many as two or three levels of auditors. In many of those settings a corporate audit group exists and that group can deliver additional and a unique set of tools – but only if the company or manager has the vision to develop exceptional talent. Practitioners can deliver education, training, project management, consulting, auditing and investigational services, enforcement and more.
However all companies will benefit from an individual or a department whose level of experience is unique, whose skill set is growing and whose judgment reflects a complex regulated world built on combinations of education, experience, maturity, contemporary risk management and more.
- Fundamentals of Auditing
- Auditors and organizations
- Auditors and reporting relationships in complex companies
- The mission of corporate departments…. Theory Z
- Goal: Independent experts that support responsible problem-solving
- Executive charge
- The role of HR
- Examples, issues, and outcomes
- The growing need for corporate problem-solvers
Course Level - Intermediate to executive-level quality and regulatory professionals. Corporate management will benefit as well.
Who Should Attend
- VP’s, Directors and Managers of the audit function
- Corporate compliance personnel
- Legal counsel
- HR staffing and organizational development
Why Should You Attend
This unique first-of-its-kind presentation focuses on the needs, skills, opportunities, and benefits of an independent audit group, typically a “corporate” department charged with making independent assessments.
While most easily set in in larger or multi-national companies, companies of all sizes typically have one group or function with a different scope and range of authority, particularly when set against the plant, divisional and corporate separations of duties.
A corporate audit group is typified by its reporting relationship to executive management, its accumulation of skills and expertise, its independence from all other groups and in some cases its ability to troubleshoot and solve problems of unusual complexity, urgency, and consequence.
Benefits and goals of this discussion include a review of these and other points:
- Benefits and characteristics of a corporate or independent audit function
- Utilizing a rigorous selection process coupled with HR and a specific personal development practice
- Establishing corporate centers of learning (“colleges”) covering quality assurance, regulatory affairs, and compliance
- Focusing independent reviewers on sites, processes, and issues that have been previously audited by other groups
- Providing insights into compliance trends utilizing internal and external data sources
- Managing a guest audit function to cultivate expertise and to employ a fresh set of eyes for both routine and emergency use
- Supporting executives as they manage product and compliance risk through independent assessments and investigations