B6.MD63 · IFS Cloud Service Management

Field Action Closure & Regulatory Reporting

Closes a field action and discharges the reporting obligations that attach to it. IFS Cloud supplies the reconciliation evidence - units corrected, removed, scrapped and unaccounted, drawn from Work Order completion and part serial history - which feeds the 21 CFR Part 806 correction/removal report, the EU MDR competent-authority notification and the recall termination request. The 806 report, the non-reportable record and the closure file itself have no standard IFS Cloud object and sit in the eQMS or Document Management.

46 details worked out · license requiredMedical Device Service variantMaster

Execution steps

6 steps

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The sequence somebody actually follows in IFS Cloud, step by step, written for a person doing the work rather than for a diagram.

Data requirements

12 requirements

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Every entity this process needs, mapped to its IFS object, marked mandatory or optional, with the source system it comes from. This is the list a data migration is built from.

Configuration decisions

5 decisions

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The choices this process forces you to make in IFS, named up front. Finding these in week nine of a program is what makes week nine expensive.

KPIs

5 measures

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What this process is measured on, so the reporting requirement is known before the process is configured rather than after go-live.

Integration points

5 integrations

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Where this process has to talk to something outside IFS, and what crosses the boundary.

Workshop questions

6 questions

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The questions to ask the business about this process, written before the workshop. This is the difference between a design session and a discussion.

Prerequisites

4 prerequisites

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What has to be true before this process can run at all: master data, other processes, setup completed elsewhere.

Industry variants

3 variants

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How this process differs by industry: the parts a utility does differently from a manufacturer, already worked out rather than discovered.

Process diagram

1 BPMN diagram

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A real BPMN diagram, editable in the platform, not a picture of one. It is the same diagram your team will annotate in the workshop.

Sources

6 citations

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Where this came from. Every process traces back to IFS documentation and release notes, so a claim about how IFS behaves can be checked rather than believed.

Every process in the library looks like this.

46 details are already worked out for this one process. A license opens them, and the other 619 processes with them.