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A Unique Hi-Q™ Program for Operational Excellence In Regulatory Compliance

The Hi-Q™ program is a multi-level approach to achieving operational excellence for pharmaceutical, biotechnology and medical device manufacturers.

Hi-Q incorporates a unique set of Q-factors™, building blocks that help companies embark on the journey to operational excellence, with extensive measurement every step of the way. Hi-Q is organized into five different levels, ranging from Level 1 (black), Level 2 (bronze), Level 3 (silver), Level 4 (gold) and Level 5 (platinum).

The intent is to reduce regulatory exposure and create a host of benefits including repeatable processes, defect reduction, ROI validation investment and highly cost-effective business solutions.

When a company reaches Hi-Q Level 4 (gold), it is excelling in most of the areas critical to success, long-term growth and shareholder value. A company achieving Hi-Q 5 (Platinum) has successfully obtained the highest degree of operational and process excellence, optimized profitability, reduced regulatory exposure and is in the strongest financial and competitive position possible.

Hi-Q Platinum graphic
Company Current State Q-Factors
/Controls
Benefits Risks CimQuest Tools
+ Gold level plus: formal implementation of Industry Best Practices to optimize processes
+ Operational Excellence
+ Process Analytical Technology
+ Six Sigma
+ Total Quality Management
+ Lean Manufacturing
+ Business Process Re-Engineering
+ Operational Excellence
+ Optimized Profitability
+ "Best of Breed" culture
+ Lowest Regulatory Exposure + Gold level plus:
+ Process Analytical Technology
+ Six Sigma
+ Total Quality Management
+ Lean Manufacturing
+ Business Process Re-Engineering
Hi-Q Gold graphic
Company Current State Q-Factors
/Controls
Benefits Risks CimQuest Tools
+ Silver level plus: Continuous Improvement Process
+ Continuous Improvement
+ Metrics/Statistical Based
+ CAPA
+ Trending
+ Mangement Review
+ Root Cause Analysis/FMEA
+ Operational Excellence
+ Reduced Time to Market
+ Reduced Manufacturing Cost
+ Minimized Variability
+ Optimize Cycle/Lead Time
+ Improved Regulatory Compliance
+ Increased Profitability
+ Reduced Regulatory Exposure + Silver level plus:
+ Regulatory Compliance Strategies
+ Architectural Solutions
+ Harmonization across operational areas
+ Technological Compliance Solutions
+ Root Cause Analysis/FMEA
Hi-Q Silver graphic
Company Current State Q-Factors
/Controls
Benefits Risks CimQuest Tools
+ Bronze level plus: implementing procedures and templates for consistent implementation from project to project
+ Repeatability from project to project
+ Defined Processes
+ Internal Auditing
+ Training
+ Supplier Auditing to Support Purchasing Decisions
+ Risk Analysis
+ Design Qualification
+ Change Control
+ Configuration Management
+ Repeatable Processes
+ Defect reduction
+ Increased awareness of Areas of Regulatory Exposure
+ Improved Risk Management and Business Decisions
+ ROI on Validation Investment
+ Cost-effective Business Solutions
+ Compliance Risks Proactively Identified + Bronze level plus:
+ Training System Development and Delivery methodology
+ PDA/ASQ Certified Auditors
+ ASQ CSQE
+ Pre-Purchased Consulting Services
Hi-Q Bronze graphic
Company Current State Q-Factors
/Controls
Benefits Risks CimQuest Tools
+ High level policies in place
+ Interpretation and implementation on a case by case basis for each project
+ Project
+ Quality System (Review/Sign-off)
+ Defined SLC
+ Defined Processes
+ Reduced Business Risk
+ Expanded Business Opportunities
+ Compliance Risks Identified and Mitigrated + Quality System Development and Implementation Experience
+ SLC Development and Implementation Experience
+ GAMP/IEEE Experience
+ Experienced Auditors
Hi-Q Iron graphic
Company Current State Q-Factors
/Controls
Benefits Risks CimQuest Tools
+ No formal process or procedures
+ Each Project is different, Rely on people rather than process
+ People
+ Good Engineering practices (informal)
+ Heavy dependence on OEM/Suppliers for compliance
+ Low Investment Cost + Inefficient processes
+ High Regulatory Exposure
+ Gap Analysis
+ Industry Affiliations Committees
 
 

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