You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organization manufactures cosmetics for major retailers. You are interviewing the Manufacturing Manager (MM)

DRAG DROP

You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time. The organization manufactures cosmetics for major retailers. You are interviewing the Manufacturing Manager (MM).

You: "I would like to begin by looking at the cleaning controls."

MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside."

Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.

You decide to raise a nonconformity.

To complete the nonconformity report click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, you may drag and drop the options to the appropriate blank section.

View Answer

Answer:

Explanation:

Nonconformity report

ISO 9001 Clause Number: 8.5.4

Nature of problem: Cleaning and sanitising records are not available for every batch.

ISO 9001 requirement that has not been fulfilled: ISO 9001 – “The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met.”

Evidence: 40 cleaning records are available for 63 batches.