A product's quality, reliability, and safety depend to a great extent on its conformance to specifications and parameters that have been tested, proven safe, and approved. FDA's Current Good Manufacturing Practice (CGMP) regulations 21 CFR Part 211, 21 CFR Part 820, and numerous ISO standards (ISO 9001, ISO 13485, ISO 14001) all require proper disposition of nonconformances/out-of-specifications (OOS).
In stringently regulated manufacturing industries, not only is compliance a serious issue, but a critical business issue. A nonconforming product, material, or component could lead to costly rework and scrapping, or worse, a product recall. Further, an unfortunate by-product of nonconformance-related activities is the loss of future productivity. In some cases, defects are detected weeks after the event and then take days to trace. The lack of a fully closed-loop process across key quality systems is preventing organizations from having the effective data for analysis that would provide early warnings and minimize any surprises.
So, how can manufacturers achieve an effective process for nonconformance/OOS identification and handling? Companies need to think about the system from an enterprise-wide approach. An effective NC/OOS system revolves around an integrated program built on technology that effectively and efficiently puts global practices and procedures in place.
Pilgrim Software offers an integrated software system designed to automate, manage, and streamline processes for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products.
Pilgrim equips its customers to effectively manage:
Planning -- The foundation of a successful NC/OOS system is adequate planning and setup. You need to define Code Rules and Ownership. What are the rules and variances to the rules? What are the processes and who are the owners? What will the failure modes be? How should you define severity levels? Who will enter the information?
Pilgrim Software’s Nonconformance/OOS management solution is scalable, simple, risk-based, and easily integrated throughout the organization, and ensures that all steps are completed for each event. It’s very important that you determine the right people to involve in the process and when and how procedure revisions will be handled, and how you will enforce these rules and procedures on a global level.
Source Error Tracking -- Many companies have a lack of connected data sources, leading to serious inefficiencies and continued repetition of mistakes. It is critical to identify, collect and record any information, from problems that may occur at business partners’ sites, through the final manufacturing, labeling and distribution lifecycle to any possible customer complaints. Without an integrated system, identifying root causes is little more than guesswork.
Pilgrim’s NC/OOS solution allows you to identify everything key to recording problems, so you can drive to the root cause and focus on prevention and correction actions. The more knowledge you have, the faster you can react. Pilgrim’s solution provides real measuring tools to enable managers to determine precisely where and when mistakes are occurring and why. Then, you can connect it to the CAPA process for automatic escalation when the situation warrants it.
A sole repository of information throughout the entire organization that includes external and internal inputs from product lifecycle, processes and quality systems, ensures that supervisors and managers can quickly access information, compare and contrast solutions to determine best practices, and monitor overall performance.
- Datasheet - Nonconformance Management
- Product Showcase - Nonconformance Management
- Product Showcase - Out-of-Specification Management
- Effectively Managing a CAPA System
- Mistake-Proof CAPA: Using Mistake Proofing to Reduce Human Error
- Process Improvement in CAPA: Using Six Sigma as a Compliance Tool to Improve Quality Systems
- Writing Your Way to Better CAPA: Improving Quality and the Bottom Line