At ChemRite CoPac, we approach every project in the same manner – with an intense focus on product quality from beginning to end. Whether an automotive appearance product or an OTC (Over-The Counter) product, each product passes through the same rigorous quality inspection process. Our comprehensive quality assurance program provides a crucial control-mechanism for consistent and sustained quality during each step of production
ChemRite’s Quality Assurance Program Includes:
- Validated quality and production controls
- Validated test methods
- Standardized document control
- Production based on customer quality specifications
- Customer approval of ChemRite quality specifications
- Batching and lot protocols
- Accurate finished good production instructions
Validated Quality and Production Controls
True quality and production control requires validated quality procedures. ChemRite’s quality procedures are outlined in our Quality Assured Manual. This comprehensive manual provides a systematic approach for each job function, lab procedure, cleaning and sanitization standard, batching, production and maintenance practice at ChemRite. Each procedure has been validated by our quality management team. Revisions to quality procedures require an entry in the document revision log and a five point sign off from ChemRite’s senior management. ChemRite employees are trained and supervised to adhere to these processes.
Validated Test Methods
In addition to the laboratory procedures contained in ChemRite’s QA Manual, ChemRite also has an extensive library of validated test controls called QATM’s (Quality Assured Test Methods). Each QATM provides detailed instructions for how to perform specific analytical tests. ChemRite quality technicians adhere to QATM’s for all quality testing. Test results are only approved if they meet pre-approved result standards.
Standardized Documentation Control
Maintaining a consistent standard of quality involves accurately recording, processing, and organizing enormous amounts of information. This is why ChemRite’s quality assurance department is equipped with a dedicated document control area. These specialists are technically trained to process each customer quality specification using the disciplined procedures outlined in our QA Manual. A consistent method of processing insures that no detail gets overlooked.
Production Based On Customer Quality Specifications
ChemRite document control specialists work with customers and vendors to gather all of the quality specifications needed to manufacture a product. These are organized into technical reference manuals called blue books. Document control uses blue books to create ChemRite QARM (Quality Assurance Raw Material), QAPM (Quality Assurance Packaging Material) and QAFG (Quality Assurance Finished Good) inspection sheets. If questions arise about a project, ChemRite’s team refers to the project bluebook and uses the customer’s quality specifications as the ultimate guide.
Customer Approval of ChemRite Quality Specifications
Each of our customers has a distinct perspective in their quality discipline. ChemRite strives to incorporate each customer discipline into our own. Our document control department translates customer specifications into ChemRite bills of material, batching instructions and quality testing specifications. This standardized translation is vital for efficiency on ChemRite’s production floor. But before any ChemRite quality specification is used it is sent to the customer for review and approval. A customer indicates approval with an authorized signature which ChemRite retains on record.
Batching and Lot Control Protocols
It is vital that a product not vary from batch to batch. ChemRite takes great pains to assure finished product quality. Once definitive batch assays have been established, we rigidly adhere to those specifications for each formulation. Authorized signatures are required for every raw addition, batching step and quality inspection. All raw materials and formulation batches are lot coded and electronically tracked. Retain samples, mix sheets and assay records are kept for future reference.
Accurate Finished Good Production Instructions
ChemRite maintains its focus on quality on the production line. Document control creates a project set up folder for every product sku. The project set up folder contains essential information such as line set up instructions, packaging set up guidelines, pallet pattern instructions, date code information, an approved bill of material, component graphics, a line personnel schematic and a GHS SDS. Project set up folders are securely stored, may only be checked out by authorized personnel and are reviewed before and after a production run for accuracy.