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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?
Put the following steps of a third-party audit into the correct sequence in which they happen.
In the context of a third-party certification audit, match the roles with the following responsibilities:
You work for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other
auditors) to audit a supplier, 'B', which provides packaging materials to your organisation. It is 4 p.m. and the audit is close to an end; you are having
an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled
for 5 p.m.
You, as audit team leader, audited top management, the laboratory, and the storage of raw materials.
Auditor 1 audited the two manufacturing lines and dispatch areas.
You to Auditor 1: "What findings would you report?"
Auditor 1: "When reviewing the Dispatch records, I noticed that during the morning two different trucks (Number 011 and 025) delivered the same
batch number of the product (Batch 33555). Truck 011 left the plant at 9.15 am and Truck 025 left the plant at 11.30 am. Procedure P-02 Rev.3 says
that trucks should carry a complete batch. The batch number, once on the truck, is captured using a QR device."
You: "OK, what do you think?"
Auditor 2: "I think that this is a nonconformity."
You: "OK. How would you describe the evidence on which the nonconformity will be based"?
Identify which one of the following statements best describes the identified nonconformity.
You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing
structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the
adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.
You: "How do you tell when the billet is ready for the rolling stage?"
Operator: "I've done this job for 20 years. I can tell by the bright red colour."
You: "What happens if the colour is wrong?"
Operator: "The billet goes back into the furnace."
You: "Is the pyrometer ever used?"
Operator: "Only in borderline cases."
You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the borderline cases.
Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.
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.
In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.
You are conducting a third-party audit to ISO 9001 and the next item on your audit plan is 'internal auditing'.
When reviewing a sample of audit records up to 5 years previously, you find that many contain non-conformance reports and no actions have been taken. You interview the Quality Manager.
You: "I have noted that many of the older files contain non-conformances that have not had any corrective action taken."
Quality Manager: "Because the business is always changing, the departmental managers tell me that the non-conformances are no longer applicable. I made a decision that any non-conformance over 3 years old is automatically closed"
You: "Do you obtain any confirmation beforehand from the appropriate departments that the non-conformances are no longer applicable."
Quality Manager: " No, because they are so old I consider that they are no longer appropriate. Please remember that we take a risk-based approach which means we audit where and when it is considered important to do so.
Select one course of action you would now take from the options.
You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM)
You: "Would you tell me about your management review process?"
QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained."
You: "May I see the records from the last two management reviews?"
Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.
An audit team leader arrives at a printing company to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. The Quality Manager wants the ISO 9001 certificate to cover the new contract.
During the audit, a team member found that some print jobs had been rejected by several clients over some months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract.
The auditor finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.
In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which
three of the following options would represent acceptable opportunities for improvement in the report?
TESTED 15 May 2024
