Quality management questions
Where do inspection points sit in the process?
Three places, each with a different job. Incoming inspection sits between goods receipt and the stock becoming available, so unchecked material never reaches a picking face. In-process checks sit on named operations inside the production routing, so the next operation cannot be confirmed until the check is recorded. Final inspection sits before despatch, after packing is complete but before the delivery note is posted. The system decides which gate applies from the item, the supplier and the operation, so the inspector is not the one remembering.
How do sampling plans work and can we reduce inspection for good suppliers?
A sampling plan sets how many units are drawn from a lot and how many defects are allowed before the lot is rejected. You attach the plan to the item and the inspection type, and the system calculates the sample size from the received quantity. Skip-lot rules then reduce the rate for suppliers who have earned it: after a run of clean receipts you might inspect one lot in four or one in ten. A supplier who has passed for two years should not be inspected at the same rate as one you approved last month. Cutting that load frees the inspector for the receipts that actually carry risk.
What happens to material that fails an inspection?
It goes on a system hold, which means the stock is moved to a quarantine location or flagged so it cannot be picked, issued to a work order or sold. A hold that only exists as a label on a pallet is not a hold, because the picker follows the screen. From there a named person records a disposition: use as is, rework, concession against a documented deviation, or reject and return to the supplier. Each disposition drives its own transaction, a rework order, a credit claim or a scrap posting, and the reason stays attached to the batch.
How is CAPA tracked and how do you know it worked?
A non-conformance is raised with the batch, quantity, defect and cost attached. Root cause analysis follows, then corrective action to fix the instance and preventive action to stop it recurring, each with an owner and a due date. The step most systems skip is the last one: a verification date, set weeks or months after closure, where someone checks whether the defect actually stopped appearing. Most CAPA systems fail there. Nobody verifies effectiveness, so the same issue comes back the following quarter with a new number and a fresh investigation.
Does the module support ISO 9001 and regulated audit requirements?
It provides the record trail an auditor asks for: approved specifications with version history, inspection results tied to the batch and the inspector, non-conformances with their dispositions and CAPA outcomes, calibration status of the measuring equipment used, and a change log showing who altered a specification and when. Where the sector requires it, electronic signature captures the sign-off identity on the record rather than on a printed sheet. The module supplies evidence. It does not supply a quality management system, and no auditor will accept it in place of one.
How does batch traceability work for a recall?
It has to run both ways. Backward, from a customer delivery you reach the finished batch, the production order that made it, the component lots issued to that order and the supplier receipts those lots came from. Forward, from a suspect supplier lot you reach every production order that consumed it and every customer who received the output. That second direction is the one that decides how wide a recall has to be. It only works if batch and serial capture is disciplined in inventory and production, so the traceability is really built there and reported here.