Solution Section 1 and 2 IRQA Exam [PDF]

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SECTION 1 1. Objectivity is an unbiased mental attitude that allows internal auditors to perform engagements in such a manner that they believe in their work product and that no quality compromises are made. ( Standard 1100 ) Impartiality is defined as actual and perceived presence of objectivity (Ref. 3.2 of ISO 170211:2015). Objectivity is sticking to the facts, being guided by the evidence and considering an event will be closer to the truth the more supporting evidence it has. Meanwhile, impartiality is not taking sides (lets see who can do this), to give up making value judgments and treat as equivalent different versions of an event, believing the truth is in the middle.

2. Being argumentative means that you try to prove that your view point is right by asserting that theirs is wrong. ... To be argumentative is to argue on every little issue. To be assertive means, to push one's own view point. Assertive is sticking to your belief or your point. In being assertive it doesn't necessarily mean that you are trying to contradict the other person In being argumentative you'd have to contradict the other person and try to prove the other person's point wrong. Assertive : - Polite and respectful at all times - Will confidently make, present and support decisions with which auditee disagrees - Is open, direct and non aggressive

3 Simple rating system This is arguably the most straightforward method to measure customer satisfaction, and the one that requires the least commitment and effort on part of the respondent. To use the star rating system, you’ll need to break down your service into the different aspects that make it up, e.g. quality, service, and speed. Each criterion is assigned a rating scale from 1 (least favourable) to 5 (most favourable), and the respondent rates it based on their experience. Customer feedback surveys

Feedback surveys allow for longer, more open-ended responses. Compared to rating systems, the type of information captured by surveys is richer, giving you a deep insight into your customer’s perception of your company. Customer feedback survey usually take longer to carry out, and rely on the customer’s willingness to dedicate enough time to answer questions honestly and in sufficient detail. You’ll also have to put in some work compiling and interpreting the results. The design and wording of the survey plays an essential role in minimising friction, and improving the response rate and the quality of the answers received. One-on-one interviews We recommend you use one-on-one interviews with your top clients, especially the ones you meet face to face with the most often. 4 Design and development verification. Appropriate verification activities should be planned in to provide assurance that the outputs of a design and development activity will meet the input requirements. EG: • Alternative calculations, • Comparing a new design with a similar proven design, • Building and testing of prototypes or computer simulations, • Checking of drawings / specifications or other documents prior to issue. 5 How then should the effectiveness be checked and recorded? The best way we know is to create a record using a form such as Effectiveness Checklist for Corrective Action Six ways to verify the effectiveness of corrective and preventive actions 1. Auditing is used when the solution involves changes to a system and verification is done to see whether the changes are in place procedurally and in use behaviorally. An example is an audit of a new-line clearance checklist to verify effective implementation of the checklist. 2. Spot check is used for random observations of performance or reviews of records. Spot checks provide immediate but limited feedback. An example is a spot-check of batch records to ensure that the pH step was performed correctly after training on the new procedure. 3. Sampling is used for observations of variables or attributes, per defined sampling plan. An example of sampling a statistical sample randomly drawn from lot XYZ123 to confirm that a defect has been removed after implementing a process improvement. 4. Monitoring iis used for real-time observations over a defined period. An example of monitoring is real-time observation to verify that changes to operator-owning practices were implemented. 5. Trend analysis is the retrospective review of data to verify that expected results were achieved. An example of trend analysis is the review of environmental monitoring (EM) data for the period covering the last 30 batches to show the downward trend in EM excursions due to process improvements.

6. Periodic product review is the retrospective review of data to verify that expected results were achieved. An example of trend analysis is the review of environmental monitoring (EM) data for the period covering the last 30 batches to show the downward trend in EM excursions due to process improvements. Section 2 1a Evidence-based Decision Making. Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. 1b An evidence-based approach to ISO 9001:2015 Clause 7.1.6 Organisational knowledge, clause 9.1.3 Analysis and Evaluation Clause 4.4 Quality management system and its processes Clause 7.1.5 Monitoring and Measuring Resources Clause 8.5.1 Control of production and service provision 2a Common methods of evaluating top management commitment are: 1. Interviews with top management The auditor can, by utilising business terminology appropriate for the top management, ask relevant questions that a) seek to obtain evidence of top management’s awareness of and commitment to quality and its relevance to the organization's overall objectives and management system, b) establish evidence of conformity to management responsibility requirements. 2. Collecting and corroborating evidence The audit team should be constantly looking for opportunities to corroborate answers received from top management when interviewed. Additional interviewing and gathering of evidence may be needed to provide such confidence. The audit team should ensure that any additional evidence of top management commitment is collected. Review the collected evidence to ensure completeness and accuracy of information to provide confidence in the conclusion drawn.

2b a) availability and relevance of policies and objectives b) the establishment of linkage between the policies and objectives c) obtaining the evidence that these policies and objectives are effective and understood throughout the organization d) ensuring that the policies and objectives are appropriate for continual improvement of the quality management system and ensure customer satisfaction. e) ensuring top management involvement in the management review. 3a diplomatic is tactful in dealing with people For example People shouldn't hear of nasty surprises at a closing meeting, or worse, from

their boss. You can get so much good will by allowing people to come up with a solution to the problem (open to new ideas.) 3b The message that delivered is not well received by the auditee, and may raise miss understanding between auditor and auditee. 4 1. Integrity: Internal auditors must always be honest and fair and exhibit trust, independence and objectivity in all work that they do 2. An auditor’s decision should not be wavered or influenced by anyone. Their actions, decisions, and reports should be as a result of careful analysis of the company’s operations. 3. Tenacious. Persistent, focused on achieving objectives; does not loose heart and give up in the face of setbacks 4. Self-relient. Acts and functions independently, while effectively, interacting with others; has faith in his judgment, and is polite 5. Decisive. Reaching timely conclusions, based on logical reasoning and analysis, investigates to the depth necessary

For Auditors : they shall be: (d) (e) open-minded (i.e. willing to consider alternative ideas or points of view), (f) observant (i.e. actively aware of physical surroundings and activities), (g) perceptive (.i.e. instinctively aware of and able to understand situations). https://www.scribd.com/doc/37983381/QMS-LA-Course-Material https://www.scribd.com/document/364435392/IRCA-QMS-Exam-Paper-Specimen2012