Batch record review: lot 8k03326 was manufactured on 10/31/2018, line convex 2 pc 2 with a total of (b)(4) market units.A batch record review was performed to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct, under icc code 413179 sap material 1161268 and manufacturing order (b)(4) the batch record review supports that there were no discrepancies related to the issue reported.There are no photographs associated with this case and no unused return sample was expected.Investigation conclusion: based on the investigation findings through revision of the batch records documentation, process observation, personnel interviewed, methodology implemented and defects simulation, the specific root cause could not be identified.Never the less, there are seven (07) conditions that could be considered, based on objective evidences and expertise, as contributor factors for this event and, one (01) opportunities for improvement were found: 1.Materials investigations: ¿ fabric rolls not rolled uniformly.¿ no welded or over welded flanges.2.Process/methods investigation: ¿ wrong adhesive tape used for joint fabrics rolls.Opportunities for improvement: ¿ introduce qc tooling used for quality inspection purpose in the calibration program to guarantee measurement assurance.3.Machinery / equipment/ software investigation: ¿ different movement relation vs cardan in the yamaha arm pads.¿ if the cognex cameras of the vision system is not clean.¿ in the vision system, the model in the system is not centralized.¿ when the yamaha is not adjusted if the web index is moved, due to the positioning of the vision system.Should additional information become available, a follow-up report will be submitted.Reporting site: 1049092.Manufacturing site: 9618003.
|