Management Data Suite
We offer a wide range of data management such as:
- User Requirement Specification document (URS);
- Standard Operating Procedures;
- Gauge R&R
- Additional PQ tests
User Requirement Specification document (URS)
The requirements stated, should be documented and agreed upon, ensuring these are realistic and feasible. At VIMEC we create a URS document as a basis for communication to all stakeholders.
This contains the requirements received from the customers but may also include requirements from the engineering department of VIMEC. Agreement on the URS forms the basis to take the next step.
The basic document may be complemented by functional & design specifications.
These updates can be derived from sample evaluation, mechanical proof of concept, optical verifications, etc.
Standard Operating Procedures
The construction of the visual inspection application is controlled through ‘Standard Operating Procedures” and checklists (where possible). This is to ensure the same procedure and work method is used for each system. This results is a specified and controlled outcome. Component / process testing phases are in place to ensure the components or functionality operated according to specification.
Critical components are tagged by a VST (VIMEC Service Tag) and listed in our component registry database. This creates a history of each component and its operation. After the completion of the inspection application the system is transferred to a tester that will subject the system to a variety of test procedure (and will also check the components and the operation). This is documented in the “Qualification document”. Both the constructor and the tested will make an entry in this document before releasing the system.
The qualification document consists of the IQ|OQ|PQ protocols. Based on history and customer requirements we also list the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
One test method used is the Gauge RR procedure. A carefully selected sample set is presented to the inspection system by multiple ‘appraisers’ (operators). The measurement results are processed and the outcome is compared to the specifications. The results are checked for R&R values & Bias. The R&R values provide information about the ‘precision the inspection system (is the same results found during each measurement cycle) while the Bias provides information about the ”accuracy’ (is the value found the same as the ‘real’ value).
Additional PQ tests
For cosmetic and printing aspects the procedure followed is similar to the Gauge RR study. A carefully selected sample set is presented to the system. This normally exists of good products that should be accepted & bad products (which can be divided into several classes). A full set of good products is measured and the results are processed. The bad products are then measured and the results are compared to ensure there is a clear discrimination between the good and bad products. VIMEC has dedicated templates in placed for information processing.