Doc. 34. Integration of hygienic and aseptic systems - english version

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EHEDG 2020, 2nd edition
Seiten / pages: 79

Summary
This document is a substantial revision of the first version, dated 2006.
The target audience, plus the scope of applicability and its limits/exclusions are described.
Guidance is given on the design- and implementation-phases and their sequencing, necessary for the hygienically safe integration of entities and systems to produce food.
Four (hypothetical) case-studies of integration-projects are given in the appendices, ranging from buildings, to pipe-couplings, to automation-systems. These are meant to illustrate how this generic integration-process can be applied to various projects, large and small.
An overview of the recommended integration-process is given in the form of a V-diagram, which shows a numbered se-quence of phases. Design-phases are on the left leg of the V and implementation-phases on the right leg. It also shows how each of the implementation-phases (right) should be validated against its corresponding design-phase (left). Each numbered phase in sequence is then detailed in a flowchart, supported by explanatory text.
The following are enhancements since the first edition.
• A distinction is made between the process for installation-qualification of systems to be placed on the market, versus those committed for use on a specific process, product, location and line.
• Explanations are given for commonly used project-terms such as commissioning and factory-acceptance test, relating them to the more generic language of this guide.
• Caveats and assessment-methodologies are given regarding ’upgrade existing’ versus ‘build-new’. In particular, regarding challenges and tasks arising when attempting to upgrade while continuing to pro-cess.
• Descriptions are given of acceptable risk-levels for entities that are not critical for safety- and/or quali-ty, versus those for entities that do have critical impact.
• The disadvantages of assessing solely based on capital cost rather than total cost-of-ownership and process-efficiency are reviewed, with respect to hygienic design.
• The capture of learning-experiences and post-project reviews.
• Considerations around self-certifications relevant to hygienic design.
• The cost and impact of design-changes versus the degree of evolution of the project
• The positive termination of design-activities (’design-freeze’).
• Responsibility and authorization for the commencement of the implementation-phases (the ‘build’)
• Guidance on the qualification/use of legacy-designs and/or corporate standards.
• Guidance on managing the risks of “pre-procurement” strategies.
• The capture of user-needs, including hidden or latent needs.
• Providing for foreseeable evolutions in needs, post project.
• Sample-lists of possible topics for checklists.
• The strategies of Design-for-Manufacture and Design-for-Validation.
• Using software-based design-tools.
• Applying a proven acceptable range (of operating-parameters and -conditions).
• Choosing actual, versus surrogate, products, for challenge-testing.
• Some penalties of failures resulting from faulty installations.
• Examples of failure-modes at Critical Control Points.
• Using a probationary period of operation.
• The advisability of joint acceptance for handover, to pre-agreed criteria.

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