Quality

Contract Manufacturing Challenges for Quality Engineering and Quality Assurance leaders

The quality review and approval process is one of the most crucial phases in any manufactured product lifecycle. Quality Engineering and Assurance leaders need to adhere to appropriate cGMP and regulatory compliance documentation, meet expected manufacturing timelines, and lower production costs. When production is outsourced to contract manufacturing partners, the magnitude of the challenge rises significantly. The brand owner, be it a pharmaceutical company, medical device manufacturer or food company, is ultimately responsible for product quality yet a virtual team across multiple external supply organizations needs to specify, review and signoff on manufactured product quality in an efficient manner.

In this virtual, contract manufacturing environment, communication, coordination and collaboration are crucial to keeping the process moving. The quality “paperwork” needs to keep moving or production schedules slip and customer deliveries are put at risk. If the contract manufacturing quality process seems like it operates in a “black hole”, it becomes impossible to proactively identify potential issues before they cause material impacts. Finally, without closely engaging the contract partner in the overall quality process, you risk not taking advantage of operational efficiency opportunities that your partner can bring to the contract manufacturing process.

How TraceLink can help Quality leaders with Contract Manufacturing challenges

• Reduce production and quality review cycle time. Ensure a clear, current and accurate picture of the actual quality review state exists across the virtual customer – contract manufacturer – supplier team. Speed reaction to reviews and signoffs waiting action through on-screen alerts, notifications and other status indicators. Connect all needed quality documentation, such as Certificates of Analysis, Batch Release Certificates, Material Safety Data Sheets, etc., to the relevant production process phase for easy review. Quickly drill down into any aspect of the quality review cycle and its documentation to review underlying record status (accessed, approved, awaiting approval, etc.).
• Speed analysis of quality review delays on production schedules. Quickly review committed ship and delivery dates tied to quality review completion milestones. Proactively notify all virtual team members of potential delays, production impacts and mitigation plans.
• Discover quality cycle time improvement opportunities. Analyze performance patterns and specific instances with respect to contract manufacturing partners, production runs, material inputs and product lines. Study root causes influencing current quality cycle times such as time lags in quality reviews, production order sequencing and inputs, and first pass approval processes.
• Improve overall manufactured product quality. Empower brand owner and contract manufacturer to jointly drive product quality through quality review cycles, spot checks and audits. Enable virtual team collaboration on quality levels and related production processes through efficient documentation review, markups, feedback and signoff.

Next steps

• Try It Yourself.  In minutes, launch a no obligation FREE TRIAL of our Predictable Supply Suite. Create your own Process Link collaborative team workspace, invite and quickly connect to virtual team members, then experience a new world of production visibility and tracking across your contract manufacturing operations!
• Demo Production Tracking.  Request a guided PERSONAL DEMO of our Production Tracking and ProcessLink solutions. On your schedule, one of our team members will take you through our solution.

Explore More

• Discover Production Tracking.  Find out how the TraceLink Production Tracking solution can give you visibility and control throughout the entire contract manufacturing lifecycle. Go Production Tracking
• Experience ProcessLink.  Review TraceLink's innovative approach to connecting you and your internal contract manufacturing teams to your partners both fast and flexibly. Go ProcessLink