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ISO-9001-Lead-Auditor Questions and Answers

Question # 1

Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

A.

Concession

B.

Correction

C.

Corrective action

D.

Preventive action

Question # 2

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.

Question # 3

During a second-party audit of a dairy farm (by a potential customer) complying with ISO 9001:2015, the auditor verifies that there is large variability in the daily production of the milking yard. The current agreement with their only customer is to provide 2,000 litres per day. However, in the last two years, they have noticed an increasing variability in daily production.

If they produce less than 2,000 litres, they are penalised with a fine of 1.5 pesos for every litre that they do not provide. If they produce more than 2,000 litres, they use the extra milk to feed the pigs.

This process has been in operation for decades. The dairy farm was founded by the grandfather of the current owners, who did not want to alter the established practices.

The auditor raises a nonconformity on the basis that the process is not under control (Clause 8.1).

If you had been the auditor, which one of the following actions would you have accepted?

A.

Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer.

B.

Apply the existing process of addressing the risks and opportunities of milk production.

C.

Retain the current contract and try to sell the occasional surplus milk to a second customer.

D.

Analyse the daily dispatch of milk for 7 days to determine its variability.

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