Ensuring Product Quality By Managing Critical Process Control Points BackgroundBackground A producer of nutritional supplements and baby formula was experiencing unclear roles and responsibilities along with poor compliance to existing procedures. This caused process steps to be missed resulting in an environment that had the potential for a mismatch of formulation, technical label copy and final product specifications. The scope of the labeling process included: Product design, Marketing, R&D, Label Design, Packaging, Technical Label Copy, Procurement, Quality Control and Production. SPG’s Consulting AssignmentSPG’s Consulting Assignment The client asked SPG, Inc. to assist them in:  Reengineer the entire label process by designing and implementing “Phase-Gate” control procedures for each sub-process.  Reduce cost and shorten cycle time.  Ensure a 3 way match of formulation, technical label copy and final product. Project Key EventsProject Key Events SPG consultants and client employees partnered in a 12-week effort to design and implement control procedures for each sub-process.  Project planning-Define approach, major activities, project master schedule, deliverables and business case.  Project Launch-Select team leaders and members, finalize team charters and conduct orientation and team training.  “As Is” Documentation-For each sub-process, develop a “Brown Paper” (large wall display) process map that includes the process steps, key documents, performance measurements and cycle times.  “Root Cause” Analysis-For the most recent “quality issues”, conduct an assessment to determine the origin or root cause of the problem and post the location on the appropriate sub- process. The result is the identification of “Quality Hot Spots” and a preliminary indication of the need for a critical point or process gate.  “To Be” Design-Each team redesigns the steps and procedures for their sub-process to eliminate low value added steps and shorten cycle times. Design in critical points and gates to ensure accountability and quality sign-off.  Roles and Responsibility Clarification-For each of the major steps in the process, develop a roles and responsibility chart to clarify functional accountability, responsibility, who is consulted for input and who is informed of actions taken.  Key Performance Indicator Development-Key measurements for quality, cycle time, compliance and delivery are established for each sub-process along with reporting frequencies and distribution rosters.  Steering Committee Approval-An executive steering committee of functional leaders is established to provide project direction and approve recommended process changes.  Documentation and Procedure Development- The “To Be” process flows are recorded in an electronic data base and procedures are updated to clearly define the process steps as well as the “phase and gate” sign-off accountabilities. This documentation can be used for employee training and process audit activities.  Implementation Launch-Each team leader partners with their functional managers to communicate, train and implement the redesigned practices and procedures. ResultsResults As a result of these improvements, the client achieved the following:  Implemented twelve process gates across the labeling process each with a single point of “sign- off” accountability for compliance and quality.  Selected sub-process “owners” along with a labeling process “project manager” to monitor compliance and expedite off schedule projects.  Reduced labeling process cycle times through the elimination of “false starts” and reworking of process steps.  Schrudder Performance Group, LLC. Proprietary Information – 1801