Building a defensible CAPA automation business case

Use two value pools

The first value pool is investigation and administration capacity. Multiply annual quality events by average effort per event, then apply a conservative time-reduction assumption. Multiply the released hours by a loaded hourly cost.

The second value pool is failure-cost opportunity. Start with annual scrap, rework, returns or other agreed cost-of-poor-quality categories. Apply a separate reduction assumption. Do not present that amount as realised savings before the process changes and customer verification exist.

Worked illustrative example

• 600 quality events per year
• 6 hours average investigation effort
• £48 loaded hourly cost
• 28% modelled time reduction
• £420,000 annual scrap, rework and returns
• 12% modelled failure-cost reduction

The model produces 1,008 released hours (£48,384) and a £50,400 failure-cost opportunity: £98,784 in total annual opportunity.

Calculate payback carefully

Divide pilot cost by the modelled monthly opportunity for an indicative payback period. Then run a downside case using lower adoption and reduction assumptions. A project that works only in the optimistic case is not ready for approval.

Measures to agree before starting

1. Median preparation time per event
2. Time spent finding relevant historical evidence
3. Evidence completeness at the first formal review
4. Repeat-event identification rate
5. User acceptance and edit rate
6. Approved value methodology and finance owner