What competence, among others, should each audit team member have?
You work as an external quality consultant for an organisation, “ABC”, which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit an external provider, “XYZ”, which provides packaging materials to “ABC”. It is 4 pm, and the closing meeting was scheduled for 5 pm.
You, as the audit team leader, audited Top Management. You explain to the audit team that you identified two non-conformities:
a. There is no documented information on the results of Top Management Reviews, as required in clause 9.3 of ISO 9001:2015.
b. There is no evidence of Top Management commitment as required in clause 5.1 of ISO 9001:2015 (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives).
All agreed to present these two non-conformities, graded as major.
As the audit team leader, select the best option on how to handle the closing meeting.
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: “I’d like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?”
Auditee: “We have made some strategic changes, the main one being that we no longer manufacture our own products in-house.”
You: “That sounds like quite a significant change. What has been the impact of that?”
Auditee: “We now mainly sell other manufacturers’ products, under their brand names, and have outsourced the manufacture of our own brand products to one of our suppliers.”
You: “What were the reasons for making the change?”
Auditee: “Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods, we had staff with little to do. This was having an impact on customer satisfaction, and meant we had to charge premium prices that made our product uncompetitive.”
You: “How did you go about the change?”
In relation to the auditor’s question about how the change was managed, the auditee mentions the steps listed below. The steps represent different elements of the Plan/Do/Check/Act cycle.
Select three steps which apply to the ‘check’ element of the cycle.
A person who provides specific knowledge or expertise to the audit team during the audit is known as a/an:
The following actions need to be carried out during a third-party audit planning stage. Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader’
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME ' s revenue dropped significantly. In addition, customers ' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME ' s documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME ' s representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME ' s top management, the audit team structured an audit test plan to verify whether ME’s QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME ' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
Li Na chose a sampling method that sufficiently represents customer complaints from both areas of ME’s operations. Which sampling method fits that description?
You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below;
Head Office and Site 1 – Day 1
Site 2 (150 km from HQ) – Days 2 and 3
During Day 1 of the audit, the client informs you that the laboratory at Site 2 has been closed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.
As the audit team leader, what would you do?
Choose the best acceptable action you could take:
A Health Trust has contracted with Servitup, a catering services company certified to ISO 9001, for one year. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager.
You find that two internal audits have been carried out in the first year by the Catering Manager. One of them indicates that complaints from patients are increasing in number, mainly due to food being served too cold. A pre-heated food trolley is sent to the wards from the kitchen. The Deputy Catering Manager comments that the trolley thermometer is often unreliable. Evidence of calibration of the thermometer cannot be produced.
Which four of the following actions could prevent the complaints from recurring?
The following are stages of an audit, put them in the order they would be conducted.
Which statement regarding the drafting of the audit conclusions is correct?
