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<p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 1 of 24</p><p>CONFIDENTIAL</p><p>APPROVED TRAINING PARTNERS</p><p>CQI and IRCA Solutions to Examination</p><p>Paper QMS2 Quality Management</p><p>Systems Lead Auditor Training Courses</p><p>(PR328 ISO 9001)</p><p>Note to markers</p><p>Markers are expected to use their experience and judgement as certificated</p><p>auditors, bound by the CQI and IRCA code of conduct.</p><p>Markers must give due consideration to logically argued solutions that might not</p><p>conform precisely to the typical solution and other answers may be acceptable.</p><p>This is especially relevant when marking sections three and four.</p><p>Marker One, and Marker Two where applicable, shall annotate students’</p><p>examination papers clearly to show where each mark is given and shall record</p><p>their justification for awarding marks outside of the typical solution. Markers</p><p>should use the margins provided for this, ensuring marks and justifications given</p><p>by each marker are clearly discernible for review by the CQI and IRCA Training</p><p>Assessor.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 2 of 24</p><p>Section one – five questions worth two marks each – maximum 10</p><p>marks</p><p>1.1 In the context of a quality management system and ISO 9001:2015,</p><p>explain, in your own words, the difference between a ‘risk’ and an</p><p>‘opportunity’.</p><p>(2 marks)</p><p>Typical solution</p><p>A risk is the effect of uncertainty. An effect is a deviation from the expected —</p><p>positive or negative.</p><p>An opportunity is a favourable situation to getting an intended result. It may be</p><p>taken or not.</p><p>Note to marker: Award 2 marks for correctly identifying the distinction.</p><p>1.2 In the context of managing an audit programme, briefly explain, in</p><p>your own words, the concept of risk-based auditing.</p><p>(2 marks)</p><p>Typical solution</p><p>The level of actual or perceived risk determines the priority, frequency and depth</p><p>against which each organisational area/function or process is audited. High-risk</p><p>areas are audited with a higher priority, more frequently and in greater depth than</p><p>low-risk areas.</p><p>OR</p><p>Areas critical to the business and/or customer needs should normally be audited</p><p>with a higher priority for completion, on a more frequent basis and in greater depth</p><p>than areas that have a lesser impact. The audit programme should also take</p><p>account of the amount and level of change, past performance and previous audit</p><p>results.</p><p>Note to marker: Award 2 marks for similarly worded answers that demonstrate an</p><p>understanding of the concept of risk based auditing.</p><p>1.3 In your own words, explain the terms ‘audit criteria’ and ‘audit</p><p>objectives’ and give one example of each.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 3 of 24</p><p>(2 marks)</p><p>Typical solution</p><p>Audit criteria are sets of policies, procedures or requirements that are used as a</p><p>reference against which audit evidence is compared, eg legislation, ISO</p><p>9001:2015, a regulation, a contract.</p><p>Note to marker: Award 0.5 marks for explanation and 0.5 marks for example.</p><p>The audit objective is the result to be achieved, eg does the QMS conform to</p><p>legislation or ISO 9001:2015 or to what degree does the QMS conform to a</p><p>regulation or legislation?</p><p>Note to marker: Award 0.5 mark for explanation and 0.5 mark for example.</p><p>1.4 Give one example of ‘infrastructure’ referred to in ISO 9001:2015</p><p>clause 7.1.3 and describe how it could affect conformity to product</p><p>requirements.</p><p>(2 marks)</p><p>Typical solution</p><p> Buildings and associated utilities, eg:</p><p>- manufacturing space – including heating, lighting, water and waste</p><p>- storage buildings – condition needs to ensure product is protected from</p><p>damage, deterioration or contamination.</p><p> Equipment, including hardware and software, eg:</p><p>- Machinery and tools – hoists, lathes, drills, grinders, hammers, grass</p><p>cutters, brushes</p><p>- Instruction manual – to operate machinery, to tune a piano</p><p>- Driving licence – specialist needs for a large goods vehicle or a passenger</p><p>carrying vehicle.</p><p> Transportation resources, eg:</p><p>- number, availability and capacity of vehicles for a taxi service</p><p>- specialist delivery vehicles (eg secure or refrigerated) to maintain product</p><p>condition.</p><p> Information and communication systems, eg:</p><p>- databases – need to provide adequate accessibility to and security of data,</p><p>for example</p><p>client details</p><p>- Internet and phones – websites availability, ease of use for customers; need</p><p>to be adequate</p><p>to meet customer requirements for response times, call handling volumes,</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 4 of 24</p><p>etc.</p><p>Note to marker: Answers may vary widely depending upon the student’s</p><p>background. Other appropriate examples are acceptable.</p><p>Award 0.5 marks each for the example and 1.5 marks for the supporting</p><p>explanation.</p><p>1.5 ISO 9001:2015 clause 4.3 states that “Conformity to this International</p><p>Standard may only be claimed if the requirements determined as not</p><p>being applicable, do not affect the organisation’s ability or responsibility</p><p>to ensure the conformity of its products and services and the</p><p>enhancement of customer satisfaction.”</p><p>Give an example of where it is acceptable for a requirement to be “not</p><p>applicable” and, in your own words, the circumstances under which this</p><p>could be justified. Where must this be stated?</p><p>(2 marks)</p><p>Typical solution</p><p>Section 8.3 Design and development of products and services - might be excluded</p><p>by a builder who uses the services of an architect to create and control a building</p><p>design. This justification must be stated in the QMS scope.</p><p>Note to marker: Award 2 marks for this or other examples that are provided with</p><p>an appropriate justification.</p><p>Deduct 1 mark if the scope is not mentioned.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 5 of 24</p><p>Section two – four questions worth five marks each</p><p>2.1 An audit should be evidence-based.</p><p>a) In your own words, briefly explain the principle of an ‘evidence-</p><p>based approach to auditing’.</p><p>(3 marks)</p><p>Typical solution</p><p>The basis of any audit is that evidence of conformance or nonconformity is</p><p>‘objective’ and therefore verifiable at the time or at a later date.</p><p>Note to marker: Marks awarded as per the underlining above, up to a maximum</p><p>of 3 marks.</p><p>b) Identify two methods by which an auditor gathers evidence.</p><p>(2 marks)</p><p>Typical solution</p><p> Interviewing people</p><p> Sampling records and documents</p><p> Observing process and activities.</p><p>Note to marker: one mark for each point, up to a maximum of 2 marks.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 6 of 24</p><p>2.2 An important auditor characteristic is the ability to remain open-</p><p>minded.</p><p>a) In your own words, briefly explain what being open-minded</p><p>means in an audit situation.</p><p>(3 marks)</p><p>Typical solution</p><p>Being receptive to other people’s points of view and willing to accept their ideas</p><p>and opinions.</p><p>Or</p><p>Not having fixed or pre-conceived ideas of how something must be done, being</p><p>receptive to new and different ways of meeting the requirements.</p><p>Or</p><p>Not interpreting one’s own prior experience of how something is done as the only</p><p>way. Listening to and being receptive to different views, and being able to accept</p><p>that others may be correct.</p><p>Note to marker: award up to 3</p><p>marks for any one of the above or for other</p><p>acceptable answers that demonstrate understanding of the concept of being open</p><p>minded.</p><p>b) Support your explanation with an example related to an audit</p><p>situation.</p><p>(2 marks)</p><p>Typical solution</p><p>Possible answer: Auditors must be open-minded and not expect every organisation</p><p>to do things the way their own company does.</p><p>Note to marker: Award 2 marks for any reasonable and realistic example.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 7 of 24</p><p>2.3 Outline five examples of audit evidence that together could represent</p><p>an absence of top management leadership and commitment.</p><p>(5 marks)</p><p>Typical solution</p><p> Not taking accountability for the effectiveness of the QMS.</p><p> Not promoting the use of the process approach and risk-based thinking.</p><p> Not communicating the importance of effective quality management and of</p><p>conforming to the QMS requirements.</p><p> Not engaging, directing and supporting persons to contribute to the</p><p>effectiveness of the QMS.</p><p> Not promoting continual improvement.</p><p> Not supporting other relevant management roles to demonstrate their</p><p>leadership as it applies to their areas of responsibility.</p><p> Not establishing, implementing and maintaining a quality policy that:</p><p>- Is appropriate to the purpose and context of the organisation and supports</p><p>its strategic</p><p>direction</p><p>- Provides a framework for setting quality objectives</p><p>- Includes a commitment to satisfy applicable requirements</p><p>- Includes a commitment to continual improvement of the QMS.</p><p> Not ensuring that the responsibilities and authorities for relevant roles are</p><p>assigned, communicated and understood within the organisation.</p><p> Top Management are not involved in the management review process.</p><p>Note to marker: 1 mark each for any of the above. Any other variations from</p><p>Clause 5 of ISO 9001:2015 are also acceptable.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 8 of 24</p><p>2.4 In an audit situation</p><p>a) Describe briefly the objective of reviewing the auditee’s</p><p>management system documentation as part of the preparation for</p><p>an audit.</p><p>(3 marks)</p><p>Typical solution</p><p>To review the system design and documentation in order to determine conformity</p><p>with the requirements of the audit criteria for the scope of the management</p><p>system.</p><p>Note to marker: Marks awarded as per the underlining, up to a maximum of three</p><p>marks.</p><p>b) List two other actions an auditor should take during the preparation</p><p>stage of an audit.</p><p>(2 marks)</p><p>Typical solution</p><p> Confirm the audit scope and criteria</p><p> Determine the audit resources needed, eg time, competence</p><p> Gain a better understanding of the organisation, its management system,</p><p>regulatory requirements and site environment</p><p> Develop an audit plan</p><p> Develop working documents (such as checklists, schedules, process flow</p><p>diagrams).</p><p>Note to marker: 1 mark for each of the above or alternative valid answer, up to a</p><p>maximum of 2 marks.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 9 of 24</p><p>Section three – three questions worth 10 marks each</p><p>3.1 A road haulage company’s quality policy statement states: “We will</p><p>meet our customer requirements 100% of the time, every time.”</p><p>The performance data shows that they have averaged 90% on-time</p><p>delivery for the previous three years. You discuss this with the Quality</p><p>Manager who tells you that this is the industry average and they are</p><p>satisfied with this performance. He explains that “most of the delivery</p><p>problems are caused by road congestion, and so we do not take any</p><p>action on late deliveries because this is out of our control”.</p><p>You ask to see the records to determine what percentage of the late</p><p>deliveries is due to road congestion. The Quality Manager states: “We</p><p>do not keep detailed records because we just know the reasons and</p><p>have concluded that at the moment we do not need to do anything.”</p><p>You ask whether they receive any complaints about the late deliveries.</p><p>The Quality Manager replies: “On occasion some customers complain</p><p>but I’m sure most of them understand that the traffic problems are out</p><p>of our control.”</p><p>a) Outline two significant areas of potential concern in the audit</p><p>situation.</p><p>(3 marks per issue = 6 marks)</p><p>AND</p><p>b) For each issue give two questions you would ask to investigate your</p><p>initial concerns. For each question quote the applicable clause of ISO</p><p>9001:2015.</p><p>(1 mark per question per issue = 4 marks)</p><p>Typical solution</p><p>Issue 1</p><p>Quality policy and performance are not aligned because the organisation appears</p><p>to be satisfied with a 90% on time delivery performance when their quality policy</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 10 of 24</p><p>states that they will meet their customer requirements 100% of the time, every</p><p>time.</p><p>Questions:</p><p> When the quality policy was last reviewed was account taken of actual delivery</p><p>performance? [5.1.1].</p><p> Does the quality policy support the organisation’s strategic direction? [5.2.1 a)]</p><p> What arrangements are in place to achieve these objectives? [6.1.1 a)]</p><p> How are quality objectives established at relevant functions and levels</p><p>throughout the organisation? [6.2.1]</p><p> Are any quality objectives set to support this commitment in the Policy? [6.2.1</p><p>a)].</p><p>Issue 2</p><p>Nonconformities do not appear to be effectively monitored and appropriate</p><p>corrective actions implemented.</p><p>There is no documented information (records) to demonstrate that analysis of the</p><p>nonconformities (late deliveries) is taking place and there is no evidence of any</p><p>corrective actions.</p><p>Questions:</p><p> How are customers communicated with following late deliveries? [8.2.1]</p><p> Are customers told in advance of their order being taken what contingency</p><p>plans are in place if deliveries are delayed? [8.2.1 e)]</p><p> Has a review been undertaken to consider if the organisation can meet the</p><p>delivery times? [8.2.3.1 a)]</p><p> How are they dealing with the customer complaints related to the late</p><p>deliveries? [10.2]</p><p> Have the risks relating to late delivery been updated? [10.2.1 e)].</p><p>Notes to marker:</p><p>The two issues described above are ones that students are likely to identify.</p><p>Markers may use their discretion and accept others, eg continual improvement of</p><p>the effectiveness of the QMS through the use of [10.1].</p><p>Award up to 3 marks for each of the 2 significant issues identified.</p><p>Award 1 mark for each investigatory question with its associated ISO 9001:2015</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 11 of 24</p><p>reference. Deduct 0.5 of a mark where the ISO 9001:2015 reference has not been</p><p>provided.</p><p>Additional - The outline of the issues and the questions should demonstrate that</p><p>delegates understand the issues and how to investigate them. Simplistic and</p><p>incomplete answers, for example “the company is not meeting their quality policy</p><p>– when did you last review the policy?” should be penalised and awarded not more</p><p>than half the available marks.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 12 of 24</p><p>3.2 You are auditing an organisation’s improvement process. You are seeking</p><p>evidence of a planned and systematic approach to improvement in</p><p>accordance with the requirements of ISO 9001:2015.</p><p>Outline in a checklist how you will perform</p><p>this audit by developing a</p><p>series of ten audit checkpoints. For each checkpoint identify examples</p><p>of the audit evidence you would want to gather and give the appropriate</p><p>ISO 9001:2015 clause.</p><p>(10 marks)</p><p>Typical solution</p><p>Leadership and commitment</p><p> Methods, approaches and resources for promoting improvement [5.1 i)].</p><p>Quality policy</p><p> Quality policy includes a commitment to continual improvement of the QMS [5.2</p><p>c)].</p><p>Organisational roles, responsibilities and authorities</p><p> People are allocated the role of reporting on opportunities for improvement in</p><p>the QMS, in particular to top management [5.3].</p><p>Planning</p><p> During QMS planning, are the risks and opportunities determined that need to</p><p>be addressed to achieve improvement [6.1].</p><p>Quality objectives</p><p> Quality objectives are established at relevant functions, levels and processes</p><p>[6.2.1]</p><p> Quality objectives are consistent with the Quality Policy [6.2.1].</p><p>Resources</p><p> Resources have been determined and provided for the continual improvement</p><p>of the QMS [7.1.1].</p><p> Organisational knowledge gained from improvements in processes, products</p><p>and services [7.1.6].</p><p>Monitoring, measurement, analysis and evaluation</p><p> Arrangements for what needs to be monitored and measured, when it will</p><p>happen, the methods to use and when the results shall be analysed and</p><p>evaluated [9.1.1]</p><p> The results of analysis of appropriate data and information arising from</p><p>monitoring and measurement are used to evaluate the need for improvements</p><p>[9.1.3]</p><p> Evidence of monitoring and measurement processes with criteria planned and</p><p>implemented. [8.1]</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 13 of 24</p><p> Evidence of monitoring of external providers’ performance against criteria [8.4]</p><p> Evidence of analysis and evaluation of data and information from monitoring</p><p>and measurement and used to identify improvement opportunities [9.1.3].</p><p>Internal audit</p><p> Audits identify opportunities to improve the QMS. Evidence of audit reports</p><p>showing nonconformities identified [9.2.1 and 9.2.2].</p><p>Corrective action</p><p> Effective corrective action is taken. Evidence of documented information</p><p>(records) showing root cause analysis and nonconformities do not recur [10.2].</p><p>Management review</p><p> Assessment of opportunities for improvement [9.3.2 f)] and documented</p><p>information (records) [9.3.3 a)].</p><p> Decisions and actions on opportunities for improvement [9.3.3 a)] and</p><p>documented information (records) [9.3.3].</p><p>Note to marker: Award 1 mark for each of the above audit checkpoints with</p><p>supporting audit evidence and appropriate references to ISO 9001:2015</p><p>requirements, up to a maximum of 10 marks.</p><p>Deduct 0.5 marks for each checkpoint where audit evidence is not given.</p><p>Deduct 0.5 marks for each instance where the appropriate reference to ISO</p><p>9001:2015 is not given or is inadequate to a maximum of 2 deducted marks (4 or</p><p>more instances).</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 14 of 24</p><p>3.3 You are carrying out an audit interview with the Managing Director. You</p><p>ask if he has set any quality objectives for the organisation. He replies</p><p>that he has set three for this year. The first is to increase sales by 10%</p><p>(volume) within twelve months. The second is for a reduction in reject</p><p>rates for product X by 20%, over the next six months. The third is to</p><p>reduce operating costs by 5% within the next twelve months.</p><p>Outline five questions you would ask to determine the suitability of these</p><p>as quality objectives.</p><p>(10 marks)</p><p>Typical solution</p><p>Students may recognise that objectives one and three may not be quality</p><p>related.</p><p>Questions should relate to how objectives relate to the quality policy,</p><p>product requirements and/or customer satisfaction and opportunities</p><p>for improvement.</p><p>For example:</p><p>1. Are these objectives consistent with the quality policy?</p><p>2. How did you determine these to be quality objectives?</p><p>3. What customer feedback was used to arrive at these?</p><p>4. What positive impact will these have for the customer?</p><p>5. How will you achieve these without adversely affecting other</p><p>customer requirements?</p><p>6. What priorities are you giving to each and how was this determined, ie</p><p>which is most important to your customers?</p><p>7. What were the quality objectives in previous years?</p><p>Other suitable queries could include references to the following:</p><p> How do you differentiate between quality objectives and other business</p><p>objectives? Do you have other business objectives?</p><p> What customer satisfaction, feedback or complaint data was used when</p><p>establishing the objectives?</p><p> How do the quality objectives link to customer requirements and customer</p><p>satisfaction?</p><p> How do these objectives satisfy the requirements for the product?</p><p> For objective two, they could ask whether this is linked to complaints or</p><p>warranty claims.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 15 of 24</p><p> What plans are in place to enable the quality objectives to be achieved?</p><p>How are you monitoring/measuring performance to determine whether the</p><p>quality objectives are ‘on track’ for being achieved?</p><p>Note to marker: Award marks for appropriate lines of investigation following</p><p>the guidance above, up to a maximum of 10 marks. Marks can also be awarded</p><p>if students:</p><p> Refer to objective one and ask a question with respect to ‘capacity’ of the</p><p>organisation and its ability to increase production without affecting delivery</p><p>(2 marks)</p><p> Link objective one with a direct requirement from customers who wish for</p><p>the product to be more readily available</p><p>(2 marks)</p><p> Make a link with objective three to the effect that the reduction in costs will</p><p>reduce or maintain the cost of the product to customers and this is based</p><p>on their customer feedback and marketing data.</p><p>(2 marks)</p><p>Total marks awarded for this question must not exceed 10.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 16 of 24</p><p>Section four – three questions worth 10 marks each – maximum 30 marks</p><p>Questions in this section are designed to test the student’s ability to analyse audit</p><p>situations, evaluate audit evidence and apply knowledge of the audit criteria</p><p>correctly.</p><p>Students are required to:</p><p>Either</p><p> Complete the nonconformity report template.</p><p>Marking scheme for a nonconformity:</p><p> For correctly identifying the scenario as a nonconformity</p><p>(2 marks)</p><p> For a clear description of the nonconformity (3</p><p>marks)</p><p> For correctly quoting relevant evidence (3</p><p>marks)</p><p> For correctly identifying the relevant ISO 9001:2015 requirement</p><p>(1 mark)</p><p> Overall clarity of the nonconformity report. (1</p><p>mark)</p><p>Note: if students raise a nonconformity report when there is no nonconformity,</p><p>0 (zero) marks will be awarded.</p><p>OR</p><p> Complete the audit investigation template, clearly stating:</p><p> Their reason(s) for thinking there is not yet sufficient evidence to</p><p>report their findings as a nonconformity</p><p>(2 marks)</p><p> How they would investigate to determine conformity or</p><p>nonconformity, including audit trails they would follow and specific</p><p>examples of audit evidence they would seek and for what purpose.</p><p>(8 marks)</p><p>Note: if students complete the audit investigation template for a situation where</p><p>there is evidence that a nonconformity exists, a maximum of 7 marks may be</p><p>awarded as follows:</p><p> Providing a valid reason why there is insufficient evidence for a</p><p>nonconformity</p><p>(2 marks)</p><p>CQI and IRCA Solutions to examination paper QMS2,</p><p>January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 17 of 24</p><p> Providing relevant audit trails as above.</p><p>(5 marks)</p><p>Note: Marks should only be awarded where the audit investigation trails are</p><p>relevant to the situation and would provide further evidence of conformance or</p><p>non-conformance.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 18 of 24</p><p>4.1 Audit situation one:</p><p>You ask the Business Controls manager for this year’s schedule for internal audits.</p><p>This shows that the ten departments in the organisation are each audited once</p><p>every twelve months and that this year’s programme has been completed.</p><p>You ask the Business Controls manager how the frequency of audits was decided.</p><p>She says that when the system was implemented three years ago, internal audits</p><p>were scheduled at intervals of twelve months. The organisation has kept to the</p><p>same schedule ever since.</p><p>You confirm that all of the scheduled audits for the last three years have been</p><p>completed and fully reported.</p><p>Over the three-year period a total of forty-five nonconformity reports (NCRs) were</p><p>raised. Of these, twenty-five NCRs were in the Purchasing department and fifteen</p><p>were in the Inspection department.</p><p>The remaining five NCRs were shared between five other departments. Three</p><p>departments had no NCRs.</p><p>Solution – nonconformity</p><p>IRCA QMS AUDIT - NONCONFORMITY REPORT</p><p>Nonconformity (2 marks for identifying the scenario as a nonconformity)</p><p>Description of the nonconformity (3 marks for identifying the failure)</p><p>The organisation is not taking into account the importance of the processes</p><p>concerned and the results of previous audits when planning the audit programme.</p><p>Evidence (3 marks for identifying the evidence)</p><p>Audit results show that 25 out of 45 NCRs from the last three years were in the</p><p>purchasing department and 15 out of 45 were in the final inspection department.</p><p>However, each department is audited once every 12 months and this has not varied</p><p>since the system was set up here 3 years ago.</p><p>ISO 9001:2015 clause and requirement:</p><p>9.2.2 An audit programme shall be planned taking into consideration the importance</p><p>of the processes concerned, changes affecting the organisation, and the results of</p><p>previous audits.</p><p>(1 mark clause and requirement and 1 mark for clarity of answer)</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 19 of 24</p><p>THIS IS THE END OF AUDIT SITUATION ONE</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 20 of 24</p><p>4.2 Audit situation two:</p><p>You are auditing a company that manufactures and sells kitchen equipment. You</p><p>notice that the company documented information (records) show a very large</p><p>number of customer returns due to malfunction and breakage. This situation appears</p><p>to have continued for several years.</p><p>You ask the Quality Manager about this and he says the company is well aware of</p><p>the matter. You ask if these products are inspected before being dispatched.</p><p>The Quality Manager tells you that any obviously damaged items are removed by</p><p>the packaging staff before being dispatched, but the small profit margin makes it</p><p>uneconomic to implement a formal inspection process.</p><p>You ask what action is taken when these products are returned. The Quality Manager</p><p>explains that most of these returns are stock items of relatively low value. Therefore</p><p>it has been decided that it is easier and more convenient to simply replace returned</p><p>items than it is to investigate and implement a solution.</p><p>Solution – nonconformity</p><p>Note to marker: the audit situation contains three nonconformities. Students</p><p>could raise one of the following nonconformities:</p><p>IRCA QMS AUDIT - NONCONFORMITY REPORT 1</p><p>Nonconformity (2 marks for identifying the scenario as a nonconformity)</p><p>Description of the nonconformity (3 marks for identifying the failure)</p><p>The organisation does not have effective arrangements in place that ensure</p><p>product acceptance criteria are met.</p><p>Evidence (3 marks for identifying the evidence)</p><p>Documented information (records) show that faulty products are being supplied</p><p>to customers on a frequent basis without activities in place to provide evidence of</p><p>conformity to acceptance criteria.</p><p>ISO 9001:2015 clause and requirement:</p><p>8.5.1 The organisation shall implement production and service provision under</p><p>controlled conditions.</p><p>Controlled conditions shall include the implementation of monitoring and</p><p>measurement activities at appropriate stages to verify that acceptance criteria for</p><p>products have been met.</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 21 of 24</p><p>(1 mark clause and requirement and 1 mark for clarity of answer)</p><p>OR</p><p>IRCA QMS AUDIT - NONCONFORMITY REPORT 1</p><p>Nonconformity (2 marks for identifying the scenario as a nonconformity)</p><p>Description of the nonconformity (3 marks for identifying the failure)</p><p>The organisation does not have the necessary arrangements in place to ensure</p><p>that product requirements are met.</p><p>Evidence (3 marks for identifying the evidence)</p><p>Documented information (records) show that faulty products are being supplied</p><p>to customers on a frequent basis without adequate monitoring and measurement</p><p>to provide data and information that will demonstrate product conformity.</p><p>ISO 9001:2015 clause and requirement:</p><p>9.1.3 The organisation shall analyse and evaluate appropriate data and</p><p>information arising from monitoring and measurement. The results of analysis</p><p>shall be used to evaluate conformity of products.</p><p>(1 mark clause and requirement and 1 mark for clarity of answer)</p><p>OR</p><p>IRCA QMS AUDIT - NONCONFORMITY REPORT 2</p><p>Nonconformity (2 marks for identifying the scenario as a nonconformity)</p><p>Description of the nonconformity (3 marks for identifying the failure)</p><p>The organisation has not implemented effective corrective action to determine</p><p>the root cause for the production of a faulty product and taken appropriate</p><p>action to prevent recurrence.</p><p>Evidence (3 marks for identifying the evidence)</p><p>Faulty products returned by customers are not subject to any investigation as to</p><p>the reasons for the faults and are simply replaced.</p><p>ISO 9001:2015 clause and requirement:</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 22 of 24</p><p>10.2 The organisation shall react to the nonconformity and take action to control</p><p>and correct it; and evaluate the need for action to eliminate the cause(s) of the</p><p>nonconformity, in order that it does not recur or occur elsewhere.</p><p>(1 mark clause and requirement and 1 mark for clarity of answer)</p><p>THIS IS THE END OF AUDIT SITUATION TWO</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 23 of 24</p><p>4.3 Audit situation three:</p><p>You are auditing the design activities at a company that designs storage and</p><p>distribution solutions as a service to customers.</p><p>You discuss a recently completed project number Q456 with the Project Manager</p><p>and are shown the customer specification, customer communication and much more</p><p>documented information (records) leading through to the final Capacity and</p><p>Operations Planning Recommendations, which is the deliverable from their design</p><p>and development process.</p><p>You ask to see the design plan for the project and the Project Manager tells you:</p><p>“We do not use design plans as such in this organisation.” You ask: “How do you</p><p>plan and control</p><p>the design to ensure everything comes out OK?’” The Project</p><p>Manager replies that they simply follow their detailed software-based project</p><p>management process as well as investing a lot of care and attention to ensure the</p><p>desired solution is achieved.</p><p>Solution – no nonconformity</p><p>Audit investigation:</p><p>There is no nonconformity. Further investigation is needed to determine the</p><p>extent to which the solution satisfies the design and development requirements</p><p>of ISO 9001:2015.</p><p>(2 marks)</p><p>Points of investigation and evidence sought:</p><p> Review the computer-based project management process to determine if it</p><p>encompasses requirements of ISO 9001:2015 for design and development</p><p>planning, planned design controls (including design reviews, and planned</p><p>arrangements for design verification and validation) as well as design and</p><p>development changes? [8.3.2, 8.3.4, 8.3.5 and 8.3.6] (4 marks)</p><p> For project Q456 check documented information (records) for evidence of</p><p>design and development planning, controls, outputs and changes [8.3.2,</p><p>8.3.4, 8.3.5 and 8.3.6].</p><p>(4 marks)</p><p> Investigate how changes to requirements and control of design and</p><p>development changes are managed through the software process, including</p><p>CQI and IRCA Solutions to examination paper QMS2, January 2017. Amended for use on certified course XXX</p><p>operated by ATP.</p><p>Page 24 of 24</p><p>any requirements to amend design and development outputs [8.2.3, 8.2.4,</p><p>8.3.3, 8.3.6]. (4 marks)</p><p> Investigate arrangements for responsibilities and authorities to maintain the</p><p>status of design documented information (plans and records) held within the</p><p>software and how access is controlled, eg read-only [8.3.2 d), 5.3, 7.5.3.1</p><p>and 7.5.3.2]. (4 marks)</p><p> Investigate arrangements for competence and training needed to use the</p><p>software and check documented information (records) for persons involved</p><p>in project Q456 [7.2]. (2 marks)</p><p> Investigate arrangements for maintaining the software and documented</p><p>information (records), eg back-up and archive [7.1.3 and 7.5.3.2].</p><p>(2 marks)</p><p>Note to marker: Other relevant points of investigation along with stated</p><p>evidence may be accepted. Maximum of 8 marks.</p><p>THIS IS THE END OF AUDIT SITUATION THREE</p><p>THIS IS THE END OF THE EXAMINATION PAPER</p>