While the complex solution would involve the outsourcing of all QC functions, the Customized QA/QC solutions would be to go one step further and implement a customized QC deployment in accordance with the risk level objectively assessed by a complex set of parameters.
The objective is to spend more of the QC budget when it is needed because the product is riskier; for example due to the product being riskier; the supplier having less experience, the schedule being more critical or the sourcing area being less reliable….and to spend less when risk is lower.
Rather than having someone in the QA department making such decision, which are sometimes hard to implement (risk of oversight, overly tight schedules, risk aversion..), they are instead made using a system based on rational criteria.
The system is based on a ranking system for suppliers, mostly based on audit and inspection track records. Likewise, there is a criticality assessment of the product and of the sourcing area based on track record and regulatory issues.
In instance where the ranking is favourable, then the various controls are lightened, to the point where FRI could be skipped altogether and substituted by a self inspection performed by the supplier.
On the other hand, where there is a poor ranking, controls are strengthened and the entire array of available tools is deployed.
This is a dynamic system in the sense that positive or negative occurrences (failed inspections, poor audit results…) will influence the rankings (promotion or demotion) and it is a positive incentive system whereby performance is rewarded by lesser costs incurred for QC solutions.
Pressure is kept in the process through constant monitoring, regular reassessment and random controls which cannot be anticipated by the supplier.
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