Continuous Assessment Record For IRCA Certified ISO 9001:2015 Auditor / Lead Auditor Training Courses [PDF]

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Continuous Assessment Record for IRCA Certified ISO 9001:2015 Auditor / Lead Auditor training courses Delegate Name:

___________________________________

Date of course:

___________________________________

Venue:

___________________________________

Principal Trainer Verification:

___________________________________

IMPORTANT INFORMATION: This document will be used by course tutors and delegates. Tutors will use this document to maintain a record of delegate performance throughout the duration of the course. Delegates will use this document for individual continuous assessment exercises to be undertaken during the course. Delegates will need to achieve an overall of minimum of 120 marks for the course continuous assessment in addition to achieving at least 50% of available marks to an individual exercise. A maximum of 50 marks are allocated to the daily tutor assessment of a delegate’s performance. A maximum of 150 marks are available for the continuous assessment exercises. Delegates are responsible for the safe keeping of this document throughout the course. Its loss could result in failure of the course. ALL INFORMATION CONTAINED IN THIS DOCUMENT REMAINS CONFIDENTIAL TO DELEGATES, TUTORS, TN CERT AND IRCA.

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Requirements for Continuous Assessment: 1 2

A continuous assessment of the performance of each delegate is a requirement on all IRCA certified courses. This assessment by the tutor(s) shall be documented (with notes for each delegate recorded throughout the course). The assessment shall be performed against the criteria as indicated in this document, and will include elements of judgement made by the tutor(s) together with the results of individual exercises. At the end of each day the designated tutor(s) shall review and complete the delegate continuous assessment summary and decide a mark for each delegate on the day’s performance. Where it is identified that individual delegates are either not understanding the subject or not participating adequately, then these delegates shall be made aware in private of the shortfall in performance.

3 4

Day 1

Day 2

Day 3

Day 4

Day 5

1 2 3 4 1 2DAILY 3 4 CRITERIA 1 2 3 /4SCORE 1 2 3 4 1 2 3 4 Contribution to discussions, questioning of tutors, communication to the class, Reporting of situations accurately and effective participation in team activities and simulation. Clarity and technical soundness of the delegate’s written assignments. Personal attributes, skills and audit management capabilities. Attitude, manner and suitability as a future auditor and, where appropriate, as audit team leader. Attendance, punctuality and participation in all class activities.

TOTALS DAILY TOTAL

A course maximum of 50 by marks Total for (Multiply 0. 5) are allocated to the daily tutor assessment of a delegate’s performance.

Continuous Assessment Exercise Results

(10 marks) DAY 1 a.m. - Understanding of ISO 9001 DAY 1 p.m. - Understanding ISO 9001 (10 marks) DAY 2 a.m. - Document Review (10 marks) DAY 2 p.m. - Assessment practice (10 marks) A maximum of 150 marks are DAY 3 a.m. - Planning available the on site audit marks) for the (10 individual assessment exercises. (20 marks) DAY 3 p.m. - Planning continuous the on site audit

DAY 4 - Auditing technique DAY 5 - Writing a nonconformity statement DAY 5 - Audit follow up DAY 5 - 5 - Summary report

(50 marks) (10 marks) (10 marks) (10 marks)

Contribution from daily Assessment Summary

TOTAL RESULT FOR COURSE 9153_CA/04

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Day1

CA Exercise No.1 ( 10 marks)

Respond to the following questions: 1. Give two reasons why an organization might wish to base its quality management system on ISO 9001:2015. (1 mark) Cost reduction Handling for time and production

2. What do understand by the term “context of organization”? (1 mark)

Scope of organizations Internal issues External isues 3. What do you understand by a term “strategic direction” ? (1 mark)

Strategic direction” refers to the actions you are taking to achieve the goals of your organizational strategy. Some companies use a “ vision ...

4. What is meant by “Risk based thinking “ in ISO 9001:2015. (1 mark)

Risk-based thinking makes preventive action part of your organization's routine. As many people think of risk in a negative way, 

5. What is quality objective? Give one example of a measurable quality objective? (1 mark)

Clause 6.2 of ISO 9001:2015 defines quality objectives and explains how to use them. Quality objectives are measurable goals relevant to enhancing customer 9153_CA/04

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satisfaction and are consistent with the quality policy. These objectives are initially established when planning your QMS and redefined in management reviews as needed. Examples can include goals to improve on time delivery, defects, or scrap. These objectives must be documented and updated as appropriate.

6. With reference to the requirement “Context of Organization”, the standard requires to determine ‘external’ and ‘internal’ issues that are relevant to the organization’s purpose. Give two examples of each of them. (1 mark) Internal issues 1-‫وجود فريق عمل مؤهل وكفأ‬ ٩٠٠١ ‫الوعي الكافي بالمواصفة‬-٢ External isues ‫المنافسة الشاملة في قطاع التوظيف‬ ‫التفتيش والمراجعات الداخلية‬ 7. ISO 9001:2015 requires organization to apply PDCA Cycle. Explain in your own words what do you understand by PDCA? (1 mark). The PDCA / PDSA cycle is a continuous loop of planning, doing, checking (or studying), and acting. It provides a simple and effective approach for solving .

8. With reference to the requirement “Determining the Scope of Quality Management System”, the standard requires the organization to determine the boundaries & applicability of the management system to establish the scope. List any two important things that are required to be considered when determining the scope ? (1 mark)

Project deliverables are tangible outcomes, measurable results, or specific items that must be produced to consider either the project or the project phase

9. ISO 9001:2015 requires organization to “determine knowledge necessary for the operation of processes”. List two each of internal & external sources of this knowledge.

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9001:2015 standards were re vised in 2015. Based on this, the business risks, improvement of internal and external ... determine knowledge necessary for the operation of processes

10. ISO 9001:2015 requires organization to “determine the controls to be applied” to externally provided processes, products & services. List the various forms of these externally provided processes, products & services.

ISO 9001:2015, 8.4.1 states, the organization shall determine the controls to be applied to externally provided processes, products and services when: products and services from external providers are intended for incorporation into the organization’s own products and services; products and services are provided directly to the ‫ح‬customer(s) by external providers on behalf of the organization

Day 1 CA Exercise No. 2 (10 marks). Identify which sub-clauses of ISO 9001:2015 are of particular relevance / importance in relation to the process approach and improvement. For each of these sub-clauses indicate what evidence could demonstrate that an organisation is using these principles in an effective manner. (you should aim to identify at least 6 sub-clauses) Assigned duties/process owners; (Clause 5.3) Assessed risks and opportunities; (Clause 6.1) Provided resources; (Clause 7.1) Maintained and retained documented information. (Clause 7.5.1) Implemented measurement criteria; (Clause 9.0) Improved the management system and its processes; (Clause 10.3)

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Day 2 CA Exercise No. 3: ( 10 marks) DOCUMENT REVIEW SUMMARY Claus e no.

ISO 9001:2015 Requirement

4.0 4.1 4.2

Context of the organization Understanding organization & its context Understanding needs & expectations of interested parties Determining the scope of QMS QMS & its processes

4.3 4.4 5.0 5.1 5.2 5.3

Leadership Leadership & commitment Quality policy Organizational roles & responsibilities

6.0 6.1

6.3

Planning Actions to address risks & opportunities Quality objectives & planning to achieve them Planning changes

7.0 7.1 7.2 7.3 7.4 7.5

Support Resources Competence Awareness Communication Documented information

8.0 8.1 8.2

Operations Operational planning & control Requirements for products & services Design & development of products & services Control of externally provided processes, products & services Production & service provision Release of products & services Control of non-conforming outputs

6.2

8.3 8.4 8.5 8.6 8.7 9.0 9.1 9.2 9.3

Performance evaluation Monitoring, measurement, analysis & evaluation Internal audit Management review

10 10.1 10.2 10.3

Improvement General Non-conformity & corrective action

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Complianc e Y/N Y Y

Comment Page 5 Page 17

Y N

Page8 Procedure not complete

Y Y Y

Page 11 Page 6 Page 13 Page11

Y Y

Page 6

N

Not done

Y Y Y Y Y

Page 35 Page 35 Pages 35 36 Page 35 Page 35

Y N

18 Not done

Y

25

Y

20

N

Not done

Y

Page 30

Y

Page 29

Y Y

Page 40 Page 41

39 33

Page 39 Page 39

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Continual improvement

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Page 39

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Day 2 pm - CA Exercise No. 4 (10 marks). Respond to the following questions: 1.

Explain why an audit team leader might wish to undertake a pre-audit visit to the organisation to be audited. (1 mark)

A pre-audit is the first step in the process of an audit. During a pre-audit, a company documents are examined to ensure that all information is correct before the company or individual undergoes an official audit.

2.

In relation to the on-site audit of the case study company, what is the “Scope” of the audit ?. (2 marks)

The scope of  auditing within an organization is broad and May involve topics such as an organization's governance, risk management and management controls over: efficiency/effectiveness of operations and management reporting, and make sure that compliance with iso 9001...

3.

Identify two considerations that should be made by an audit team leader in determining the size and composition of the audit team ? (2 marks) 1-Competence 2- Neutrality

4.

Identify two duties of audit “Guides”. (2 marks)

1-making check list of the Audit 2-making corrective actions for non conformity 3- making final report

5.

In relation to the case study company identify six ISO 9001:2015 clauses that you would wish to verify in order to establish that the case study organisation is effectively managing and has adopted the “Risk based & process approach” in relation to the “ home delivery” process. (3 marks)

Clause 6.1 Actions to address risks and opportunities Clause 6.3 Planning of Change

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ISO 9001:2015 Clause 7.1.4 Environment for the Operation of Processes ISO 9001:2015 Clause 8.1 Operational Planning Clause 8.3 Design and development of products and services Implemented measurement criteria; (Clause 9.0) Improved the management system and its processes; (Clause 10.3)

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Day 3 - CA Exercise No. 5 (10 marks). With reference to the “Role Play” audit that you are to undertake in the case study company. produce a “Check List” containing closed ended questions as directed by your tutor(s). This check list should also be written onto flip chart sheets to enable you to make a formal presentation and also for use during the audit role play.

Does the product have batch no ? 8.2 Has the organization discuss the internal and external isues ? 4.1 Is the employee have awareness on the organization policy? 7.3 Does the organization having archive system ? 8.3 Does the organization implement internal Audit ?9.2

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Day 3 CA Exercise No. 6a (10 marks). With reference to the “Role Play” audit that you are to undertake in the case study company. you have already produced check lists containing closed ended questions in order to verify that the organization is meeting the ISO 9001 requirements of Clause 4.1, 4.2 & 6.1 in relation to Strategic Planning and Clause 8.4 in relation to Outsourced process of ‘home delivery service’ Your team leader also requires you to assess the organization’s approach in : (1) implementing ‘process based quality management system’, and (2) evaluating performance & effectiveness to meet customer requirements & enhance customer satisfaction, in relation to the ‘Home Delivery Service Process’ . a) Produce a Check List containing closed ended questions, for the ISO 9001 requirement 4.4.1 (Quality management system & its processes) to respond to team leader’s query (1) as above. (5 marks) b) Identify 5 other ISO 9001 clauses that you would wish to verify to respond to team leader’s query (2) as above. (5 marks)

Does the organization determine the input and output of the process? Does the organization implement the thinking based on risk? Does the organization determine the sequence interaction of the process Does the organization determine the sources which needs for the process? Does the organization doing internal Audit on its process and system?

B Clause 7.12 Clause7.3 Clause8.2.4 Clause 8.2.1 Clause 9.1

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Day 3 CA Exercise No. 6b (10 marks) In relation to these peviously identified six clauses identify where in the organisation you would visit and what evidence you would wish to see in order to evaluate the effectiveness of the organisation’s approach to performance evaluation, customer satisfaction and the implementation of the company Quality Policy in relation to the “Home Delivery Service Process” (you are producing a limited auditor’s “Plan of Action” and associated checklist containing closed ended questions). 1. Asking customer service manager for measuring and monitoring input and output of the process? 2. Asking about complaints and recalling system is that implemented ? 3. Asking about policy and are the employee's are understand it? 4. Asking about organization plane and objectives?

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5. Day 4 - CA Exercise No. 7 (Auditing Technique) (50 marks). The tutor(s) will judge each delegate against the following criteria: S. No.

Parameter

1

Interpersonal skills (Rapport with auditee / Sensitivity to auditee / Feedback of information)

2

Use of Check List / Audit sample selection

3

Questioning / listening skills

4

Interpretation and evaluation of audit evidence / Trail following

5

Note taking

Marks out of 10

Total Marks

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Day 4 - CA Exercise No. 8 (10 marks). Following your audit of the case study company, review your personal notes and write what you consider to be the most significant nonconformity on the assessment nonconformity report form below. Complete the form as it would be completed by an auditor during the assessment process:

XYZ CERTIFICATION LTD. Company audited: 17 -6 - 2020 Date: Auditor’s name: Asem abdelhamid Non conformity statement: Failure in the planning of design

Evidence Page. 17 Clause

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Day 5 - CA Exercise No. 9 (10 marks). _____________________________________________________________________________ Non Conformity Report Report Ref. No. 201y/1 Process : Operations (Storage)

Auditor : Soames

Audit Date : 12/03/201y Auditee : Y. Chug

AUDIT FINDINGS : (Non-Conformity): The various packets of grocery material were not being handled as per work instruction GSM/Op/WI/9, rev 3,. This was resulting in damages of the goods and loss of goods due to scrap. Acceptance By : Y. Chug _____________________________________________________________________________ CORRECTION - MITIGATING ACTION : The personnel in stores were new and were not aware about the work instructions and were keeping the material in an incorrect way. Replaced the packets and repacked into proper packing as instructed by the customer service manager. CORRECTIVE ACTION -ON THE CAUSE: The induction training of stores persons shall be modified to include this concern. One point lesson shall be communicated to relevant personnel who are working in stores as of date. Audit Management : Y. Chug _____________________________________________________________________________ Suggest a suitable approach that an auditor might take to verify that the corrective action is effective in dealing with the root cause of the problem. Making training for ISO 9001 and storage procedure to new employee Making sops explained goods storage and training the employee on it Making handling for logbooks and delivery orders

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Day 5 - CA Exercise No. 10 (10 marks). You have been requested to provide an executive summary report for your 'client' communicating the assessment results (to a busy senior director). This report needs to address only the headings given below: Objectives and scope of the assessment .

Scoop from quality manual Objective from iso 9001 :2015

Conclusions (positive findings / main areas of weakness).

Positive.. organization chart Weakness .. employee not have enough training

Overview of findings (related to areas of the company or requirements of ISO 9001:2015). Have the ISO 9001:2015 certificate after clothing Non conformity pints

Recommendations (Your recommendation to company audited). 9153_CA/04

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