IRIS certification audit of a brake caliper manufacturer
A brake caliper manufacturer applies for IRIS certification (ISO/TS 22163) for its site in Eastern Europe, supplying three rolling stock OEMs. During the stage 2 audit you find: three customer complaints in the last 12 months for hydraulic leaks at the caliper seal; internal scrap of 8.5%; a process capability of Cpk = 0.91 for the critical bore diameter against a customer requirement of 1.33; welding subcontracted to a company with no qualification records for the special process; a KPI board showing 100% on-time delivery, but the figure excludes expedited shipments that represent 12% of orders; and two major nonconformities from the previous surveillance audit still open with the same root cause. The company presents a 40-page improvement plan and asks for certification to be granted with a six-month window to close the open findings.
1. What certification decision should the audit team recommend?
Read the worked answer
The recommendation should be not to grant certification at this stage. Under ISO/TS 22163, major nonconformities must be closed and verified before a certificate is issued; a six-month window is not a substitute for closure. The two open major nonconformities with the same root cause indicate that the previous corrective action was not effective, which is itself a system failure. The three leaks, the Cpk of 0.91 against a 1.33 requirement, and the unqualified welding subcontractor are separate major findings because they affect product conformity.
The KPI showing 100% on-time delivery while excluding 12% expedited orders is a data integrity issue and undermines the management review process. A 40-page plan does not demonstrate effectiveness. The correct output is a major nonconformity report with a requirement for root-cause analysis, corrective action, verification and a re-audit before certification.
2. Assess the improvement plan and specify what a credible corrective action would contain.
Read the worked answer
The plan's length is not the issue; its content is. A credible corrective action for the leaks would contain containment (quarantine of affected calipers, customer notification), root-cause analysis (seal material, bore surface finish, assembly torque, test method), and verification by a designed experiment or capability study. For the Cpk finding, the company must show the process is stable, identify the special causes, and demonstrate Cpk at or above 1.33 over a sustained period, not a single study.
For welding, the subcontractor must be qualified to EN 15085 and ISO 3834, with weld procedure specifications, welder qualification and NDT. The plan should have owners, dates, evidence and effectiveness checks, and the internal audit process should be strengthened so that the same findings do not recur. A monthly review by top management would be expected.
3. How should the auditor treat the KPI manipulation and the subcontractor issue?
Read the worked answer
Both should be raised as nonconformities, not just observations. The KPI excludes expedited shipments that are 12% of orders, so the reported 100% on-time delivery is misleading; the auditor should test the KPI definition against the customer requirement and the process owner's understanding, and raise a nonconformity against the performance evaluation and data analysis requirements. This is also a warning sign about the integrity of management review.
The subcontractor welding issue is a nonconformity against the control of externally provided processes: the company must demonstrate qualification of the special process, flow-down of requirements, and verification of the subcontractor's output. If the subcontractor cannot be qualified, the process must be brought in-house or the product re-designed. Both findings should be followed up at the re-audit with objective evidence.