The project procedure

Published: 12-Feb-2003
Packaging


Phase 1: Initial meeting After the contract has been awarded, a meeting is organised between the project managers of the two parties to confirm the user technical specifications (URS) contained in the order and to ensure common terminology.

Phase 2: from project review (PR) 1 to 3 A file is produced which contains all the qualification documentation and this is kept up to date as the project proceeds. The documentation is agreed with the customer.

FMEA (Failure Mode and Effects Analysis) The analysis of risks associated with the assembly system allows an assessment of the assembly methods as a function of the following criteria – frequency, effects and recognition of the risks. This analysis is carried out with the customer.

Functional Specifications The functional specifications of the machine are produced. This involves a description of the mechanisms and the behaviour of the control systems for the complete process – stations and machine.

Quality Plan The individual phases for the qualification of the assembly system and its integration in the Mikron quality system are described in the quality plan.

Design Qualification (DQ) All documentation produced and used for the design and development of the assembly equipment is collected: URS, functional specifications, FMEA report, list of important deviations, quality plan, description of components to be assembled, list of the people participating in the project.

Phase 3: from PR 4 to 5 The documentation is prepared and the responsibilities established for the IQ and OQ records. The documentation used is agreed with the customer.

Phase 4: from PR 6 to 7 Mikron tests the machine under real production conditions and performs the qualifications.

Installation Qualification (IQ) Checking whether the assembly system is designed in accordance with specifications and whether the calibration systems are to standard. The responsibilities for the production of the IQ records are established. IQ test sheets are used to confirm and record the checks. A deviation report summarises all the deviations which have been found during the IQ tests. Each deviation must be documented and contain a list of the corrective measures taken. The qualification report contains the list of the tests carried out (IQ test sheets) and the results. This report must be signed by the customer before the procedure continues to the next stage.

Operational Qualification (OQ) Checking whether the assembly system functions correctly and corresponds to the specifications. The responsibilities for the production of the OQ records are defined. OQ test sheets are used to confirm and record the checks. The qualification report contains the list of the tests carried out and the results. This report must be signed by the customer before the procedure continues to the next stage. After the IQ and OQ records have been produced, Mikron can be assured that the complete documentation is correct and that the system satisfies all the criteria. This phase represents the end of the qualifications carried out by Mikron, but the project does not end at this stage.

Phase 5: PR7, Pre-acceptance Factory Acceptance Test (FAT) The machine is tested under real production conditions at Mikron's premises with the customer in attendance. A pre-acceptance report for the assembly system is prepared, signed off and the system sent to the customer's site.

Phase 6: PR 8, final acceptance, to PR 9 Site Acceptance Test (SAT) The final acceptance (SAT) is carried out by the customer at their premises with support from Mikron. The customer's operators control the assembly line. A final acceptance report for the assembly system is signed after this phase. The customer also conducts the IQ and OQ tests at this phase.

Performance Qualification (PQ) The qualification is carried out by the customer on site (SAT), and is their responsibility. If requested, production support is available from Mikron.

Phase 7: PR 10, Debriefing Mikron meets with the customer approximately three months after final acceptance to analyse the project as a whole.

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