Investigate the Apex Level flow failure and check pack weights

What is going on

Batch B26-4418 of Apex Level, 1,200 bags, failed the flow table test at 128 mm against a specification of 140 to 160 mm and is on hold in the quarantine bay under NCR-26-071. The batch record shows the blend ran on blender 2 on the night shift with a 15 minute stop for a tripped motor. The cellulose ether additive came from a new supplier lot received the day before. Sanjay Pillai wants a retest of the retained sample, a root cause analysis with the night shift operators and a recommended disposition. He also wants the 20 bag pack weight check completed on the held pallets, because a hardware customer has queried bag weights and the trade measurement rules for pre-packaged goods apply.

Your brief

Retest the retained sample, analyse the batch record and raw material lots, run a structured root cause analysis, complete and record the pack weight check against the labelled weight requirements and recommend a disposition for the batch with corrective actions under the nonconformance procedure.

Work through it

You do not need to do it all. Doing a few of these will show you what the work is like. Your ticks and notes stay on this device.

• Read the nonconformance, hold and corrective action procedure and confirm the hold tag and quarantine location of the 1,200 bags in the batch and production log.
• Retest the retained sample on the flow table using the test method, and test a sample from a held pallet, recording both results in the quality test register.
• Review the batch record for B26-4418 including blend time, the motor stop and the additive lot, and compare the additive lot with the certificate of analysis from the supplier.
• Run a five whys or cause and effect analysis with Kieran Bosworth and the night shift operator, and record the likely root cause with the evidence that supports it.
• Complete the 20 bag pack weight check on the held pallets, compare the average and the lowest bag with the labelled weight and tolerable deficiency, and record the result.
• Recommend a disposition for the batch from the options in the procedure, with a rework instruction and retest plan if rework is proposed.
• Draft corrective actions with owners and due dates, including any change to the supplier approval of the additive, and update NCR-26-071 in the quality test register.

What someone in this role would produce

• Retest results in the quality test register
• Root cause analysis record
• Pack weight check record with the trade measurement comparison
• Disposition recommendation and corrective action list for Sanjay Pillai