Monthly Non-Conformance / Customer Complaint Review Review Date: July 2026 Review Period: Approximately the last six months of issues reviewed. Based on the supplied report. 1. Executive Summary Overall assessment: Minor Concerns The report is largely consistent with a well-controlled Quality Management System. As expected, the vast majority of entries are routine audit activities, automated order error logs, administrative reviews or return-to-supplier investigations that have already been assessed and concluded as requiring no CAPA. Approximate breakdown Issues reviewed: ~70+ Items requiring management attention: 4 Overall quality status: Minor Concerns – System remains under control There is no evidence of deterioration in the QMS. 2. New Issues Requiring Management Attention Issue 401567 0110229 QA Data Requires Risk / Non-Conformance Review (July 2026) Summary High QA failures identified for one product with unacceptable date codes. Why it matters Although this is marked as an information issue, unacceptable date codes have now appeared alongside previous supplier age/date-code concerns. Recommended Action Continue monthly trend monitoring. Compare against previous Teledyne batches. Escalate only if the trend continues or customer impact occurs. Priority: Medium Issue 401472 BOX1065 – Old date code sensors received from supplier Summary Another batch of old-date-code sensors received from Teledyne. Why it matters This is not a Viamed non-conformance, however it represents another supplier quality occurrence. This follows similar events previously reviewed. Recommended Action Continue supplier trend analysis. If further occurrences arise, raise formally with supplier management. Priority: Medium Issue 401113 BOX1073 – Old date code sensors Summary Further occurrence of aged oxygen sensors received. Why it matters This strengthens the supplier trend already seen over recent months. Although returns are appropriate, the repeated nature should remain visible during supplier review. Recommended Action Maintain supplier performance monitoring. Consider discussing cumulative occurrences during supplier review meetings. Priority: Medium Issue 397289 (Still Open) Stock memos not being read Summary Production reports office staff continue missing stock memo instructions. Robert has agreed to monitor improvement following further staff discussions. Why it matters Unlike isolated order errors, this has now been specifically identified as a recurring behavioural issue. Potential consequences include: delayed production delayed customer deliveries increased internal rework Recommended Action Monitor for another month. If repeated again, consider: refresher training acknowledgement mechanism for critical stock memos targeted CAPA if recurrence continues Priority: Medium 3. Recurring Trends Supplier Quality Continued reports of: aged stock old manufacturing date codes oxygen sensor returns These continue to appear but remain appropriately managed by: returning goods to supplier recording trend data deciding no internal CAPA Current evidence still indicates a supplier monitoring issue rather than an internal process failure. Office Order Errors Routine office mistakes continue, including: pricing memo omissions dispatch promises carriage checking stock availability Shopify fulfilment postcode errors These are generally: low impact individually corrected already fed back to staff No evidence suggests the error rate is increasing significantly. Personnel Dependency Several completed audits identified the same observation: heavy reliance on Derek reliance on Helen some processes having only one trained individual This appears repeatedly across: Calibration Production Post Market Surveillance Handling & Storage Although not a non-conformance, it is a genuine organisational resilience risk and should remain on the Management Review agenda. Audit Programme The internal audit programme appears healthy. Recent audits consistently concluded: PASS No Non-Conformances Observations primarily relate to: resilience documentation improvements process maturity This is a positive indication of QMS effectiveness. 4. Follow-up Required Continue monitoring: Supplier Date Code Trend Continue watching repeated aged Teledyne sensors. No escalation yet, but trend should remain visible. Stock Memo Compliance Review next month's error log. If failures continue, formal corrective action may become appropriate. Observation 399444 Calibration COP / "How To" document remains a worthwhile improvement. Completion should be monitored. Cross-training Several audits recommend reducing reliance on key personnel. Continue implementing: backup staff cross-training succession planning 5. Overall Assessment The Quality Management System continues to appear stable and under control. The report contains exactly what would be expected from a mature management system: numerous automated monitoring issues, routine office corrections, supplier returns, completed audits, periodic reviews. Importantly: No significant customer complaint trend was identified. No evidence of increasing internal process failure. No significant regulatory concerns were identified. No product safety concerns requiring immediate escalation were found. No new CAPA candidates were identified from the evidence reviewed. The only areas that continue to warrant management monitoring are: Repeated supplier date-code/aged stock issues from Teledyne. Ongoing compliance with stock memo instructions. Organisational resilience through increased cross-training and reduced dependency on a small number of key personnel. Management Conclusion This month's review does not indicate any deterioration in the effectiveness of the Quality Management System. Operational controls appear effective, audits continue to report no significant non-conformances, customer complaints remain minimal, and identified issues are generally being corrected through normal operational management without requiring formal CAPA escalation. Continued monitoring of supplier performance and organisational resilience is recommended, but the QMS remains effective and under control.