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QMS LAC Continuous Assessment

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Che Faltado
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100% found this document useful (1 vote)
271 views23 pages

QMS LAC Continuous Assessment

Uploaded by

Che Faltado
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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QUALITY MANAGEMENT SYSTEM

ISO 9001:2015
Continuous Assessment

Continuous Assessment Record


for

Student Name: Cherrieson Faltado

Date of course: 25-29 November 2024

Venue: Virtual Training

Continuous Assessment Exercise Results

Daily Student
No Assessment Exercises Points
Exercises score
1 Understanding of Quality Management 10
DAY 1 System
2 Documenting Management System 10
Requirements
3 Documented Information Review 25
DAY 2
4 Preparation of Audit Plan 20
5 Ethical conduct an auditor 10
DAY 3
6 Writing of Audit Checklist 20
7 Conducting Opening meeting 25
DAY 4
8 Practical Auditing 20
9 Writing Nonconformity 30
10 Conducting Closing meeting 25
DAY 5 11 Writing Audit Summary 10
12 Follow-Up Audit 10
Student’s assessment by the Tutor 25

TOTAL RESULT FOR COURSE (240 points)


(168 passing mark)

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QUALITY MANAGEMENT SYSTEM
ISO 9001:2015
Continuous Assessment

For Tutor’s use, this document is for tracking student’s individual performance
during the course duration. Individual continuous assessment exercises are
recorded in this document.

The student needs 70% of the total score in these exercises to achieve a passing mark for
this course.

Continuous Assessment (CA) is designed to be used by the Tutor as method for


validating each student’s achievement of the Learning Objectives specified in these
relevant IRCA course criteria.

Requirements for Continuous Assessment:

1. Continuous Assessment is based on individual performance of Students as


requirement on all IRCA certified courses.
2. Students are assessed based on the results of individual achievements in their
task and group CA.
3. Tutors assess each student by awarding scores according to the enumerated
criteria at the end of this document.
4. The scores of numbers 2 and 3 are added that comprises the Student’s grade of the
Continuous Assessment.
5. Students answer the CA in this document and at the end of each day the tutor(s)
mark(s) and determine if the scores obtained is 70% of the total Continuous
Assessment Exercise Results.
6. Students shall be made aware in the beginning of the evaluation if he/she is not
coping well and shall be advised in private.
7. This assessment is documented by the tutor(s).

Tutor Intervention/Coaching if the student is not achieving the Learning Objectives.

Day Time Area of Concern Hours

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ISO 9001:2015
Continuous Assessment

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QCA073 01 19
QUALITY MANAGEMENT SYSTEM
ISO 9001:2015
Continuous Assessment

Day 1 - CA 1: Understanding Quality Management and ISO 9001 Standard. Answer the followings.
Choose the correct answer by encircling the corresponding letter. (10 points)

1. Management -

a) degree to which a set of inherent characteristics of an object fulfils requirements


b) organization consisting of member organizations or persons
c) coordinated activities to direct and control configuration
d) coordinated activities to direct and control an organization

2. Quality

a) degree to which a set of inherent characteristics of an object fulfils requirements


b) organization consisting of member organizations or persons
c) coordinated activities to direct and control configuration
d) coordinated activities to direct and control an organization

3. quality control

a) activities for control of the output after formal approval of its product configuration
information
b) part of quality management focused on providing confidence that quality
requirements will be fulfilled
c) part of quality management focused on fulfilling quality requirements
d) coordinated activities to direct and control an organization

4. quality assurance

a) degree to which a set of inherent characteristics of an object fulfils requirements


b) part of quality management focused on providing confidence that quality
requirements will be fulfilled
c) part of quality management focused on fulfilling quality requirements
d) coordinated activities to direct and control an organization

5. quality improvement

a) part of quality management focused on increasing the ability to fulfil quality


requirements
b) part of quality management focused on providing confidence that quality
requirements will be fulfilled
c) part of quality management focused on fulfilling quality requirements
d) coordinated activities to direct and control an organization

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ISO 9001:2015
Continuous Assessment

6. system

a) degree to which a set of inherent characteristics of an object fulfils requirements


b) organization consisting of member organizations or persons
c) set of interrelated or interacting elements
d) coordinated activities to direct and control an organization

7. quality management system

a) set of interrelated or interacting elements of an organization to establish policies


and objectives and processes to achieve those objectives
b) organization consisting of member organizations or persons
c) set of interrelated or interacting elements
d) set of interrelated or interacting elements of an organization to establish quality
policies and objectives and processes to achieve those objectives with regard to
quality

8. Give one purpose of Quality Management System

The purpose of the QMS is to ensure that the company processes are consistently compliant
with the customer needs / requirements.

9. Give one purpose of quality management system standard

The purpose of implementing QMS Standard is to help the organization be more efficient and
improve the interested parties satisfaction.

But based on the presentation, one of the QMS Standard efine goals and objectives for quality.

10. Give one business benefits of an improved Quality Management System

One of the business benefits of an improved QMS is to increased customer satisfaction,


improved business process, compliance to regulations, etc.

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ISO 9001:2015
Continuous Assessment

Day 1 - CA 2: Quality Management System Process. Choose the correct answer by checking the
corresponding letter. (10 points)

1. What should organization need to consider 6. What process of QMS that provides
in planning, establishing, implementing and information on whether the QMS conforms to
maintaining an audit program? the organization’s own requirements for its
QMS?
a. frequency
b. method
a. Quality Management System Planning.
c. responsibilities
b. Procedures necessary to ensure effective
d. planning requirements and reporting
planning.
e. all of the above.
c. Legal and other requirements.
d. Internal Audit.
e. None of the above.
2. What issues should be verified in
evaluating the performance of QMS?
a. the process 7. When planning how to achieve the quality
b. customer evaluation objectives, what must organization determine?
c. what needs to be monitored and measured.
d. All of the above a. the need and expectation of external provider.
e. None of the above. b. how the results of planning will be evaluated
c. how to apply only the correction to
nonconformities.
3. What controlled conditions included in d. All of the above.
organization implementation of production e. None of the above.
and service provision?
8. What requirement of the organization that is
a. the availability of documented information necessary for the operation of process and
b. Those processes that define relation gained through experience?
between an organization and its a. organizational knowledge
customers. b. Support
c. All processes that have an impact on c. Monitoring and measurement
customer satisfaction d. all of the above
d. All of the above
e. none of the above
e. None of the above

9. What should the organization monitor that will


4. What should organization communicate to measure the needs and expectation have been
its external providers? fulfilled?
a. Product input a. Performance evaluation.
b. requirements for products and services; b. Product and services output.
c. Customer background. c. Customer satisfaction.
d. All of the above. d. All of the above
e. None of the above. e. None of the above

5. What requirements of QMS that engagement 10. How will organization determine opportunities
of people enables provision of adequate for improvement?
human and other resources?
a. improving products and services to address
a. Leadership future needs and expectations
b. Organizational Knowledge. b. correcting, preventing or reducing undesired
c. Actions to address risks and opportunities. effects;
d. Support c. improving the performance and
e. none of the above. effectiveness of the quality management
system.
d. All of the above
e. None of the above.
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ISO 9001:2015
Continuous Assessment

Day 2. CA 3: Document Review (25 points) 1 point for inadequacy identified, .5 for adequacy

Adequate?
ISO 9001 Requirements √ if Yes or x State reason/s if found inadequate.
if No
4. Context of the organization
41 Understanding the organization and its
context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality
management system
4.4 Quality management system and its
processes
5. Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities
and authorities
6. Planning
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and planning to
achieve them
6.3 Planning of changes
7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication

7.5 Documented information


8. Operation
8.1 Operational planning and control

8.2 Requirements for products and .


services
8.3 Design and development of products
and services
8.4 Control of externally provided
processes, products and services
8.5 Production and service provision

8.6 Release of products and services

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Continuous Assessment

8.7 Control of nonconforming outputs

9.0 Performance Evaluation


9.1 Monitoring, measurement, analysis and
evaluation
9.2 Internal audit
9.3 Management review
10. Improvement
10.2 Nonconformity and corrective action

10.3 Continual improvement

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ISO 9001:2015
Continuous Assessment

Day 2. CA 4. Group work (20 points)

Using the Quality Management System manual of the case study company prepare an Audit plan for all
activities of URISE Packaging Corporation.

AUDIT PLAN Date:

ORGANIZATION:

ADDRESS:

MANAGING DIRECTOR

CONTACT PERSON: Contact No.:

Scope:

Audit Objective:

Audit Criteria:

Audit Team Leader:

Audit Team Members:

Technical Expert (if appropriate):

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Continuous Assessment

AUDIT PLAN OF ACTION

Time Activities Auditor Auditee

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ISO 9001:2015
Continuous Assessment

Day 3 – CA 5. Individual works. Responsibilities of an auditor. (10 points)

1. IRCA code of conduct for auditor states “demonstrate sensitivity for the customs,
working practices, culture and personal beliefs of others”. Explain this statement
by an example when applied in auditing. (2 points)

2. What is the importance of the need for effective communication of the auditor with the
auditee? (2 points)

3. Give 2 examples on how an auditor can keep the need for the auditor’s confidentiality. (2
points)

4. As a professional competent auditor, give four ways on how you should behave. (4
Points)

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ISO 9001:2015
Continuous Assessment

Day 3. CA 6. Writing Audit Checklist (20 points)

Prepare an audit checklist for Auditing – role play to evaluate URISE Packaging Corp. UPCL by
preparing question opposite the description. Give the ISO 9001 clause at the end of each
question:

SN Description Checklist
Evaluate the auditee’s
understanding and
implementation of the
relationship between external
1 and internal issues, the relevant
requirements of relevant
interested parties, the actions to
address risks and opportunities,
and the quality management
system processes
needed to implement them
2 Evaluate the boundaries,
applicability and scope of the
quality management system,
including the types of products
and services
covered and justification for
any requirement not
applicable
3 Evaluate the auditee’s
determination of customer, and
applicable statutory and
regulatory requirements

4 Verify that the quality policy,


as established by top
management: • reflects the
purpose and context of the
organization and supports its
strategic direction
a. commits to compliance
with requirements,
including customer and
applicable statutory and
regulatory
requirements
b. commits to
continual
improvement
c. is communicated by top
management and
understood within the
organization

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ISO 9001:2015
Continuous Assessment

d. is available to interested
parties.

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ISO 9001:2015
Continuous Assessment

5 Evaluate the auditee’s


arrangements for planning
including: •
a. Quality objectives consistent
with the quality policy have
been established at relevant
functions and levels within
the organization, and are
measurable, monitored,
communicated and updated
b. Roles, responsibilities and
authorities have been
assigned, communicated
and understood within the
organization

c. Determining support
requirements, including
human resources; their
competence and awareness;
the infrastructure and work
environment; and the
monitoring and measuring
resources

d. Operational processes
including the determination
and review of requirements,
design and development,
production and service
provision and release,
external provision and
nonconforming outputs
e. Considered the external and
internal issues, the relevant
requirements of relevant
interested parties, and
determined the risks and
opportunities that need to be
addressed to give assurance
that the quality management
system can achieve its
intended result(s), prevent or
reduce undesired effects,
enhance desirable effects
and achieve continuous
improvement

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ISO 9001:2015
Continuous Assessment

f. Change to the quality


management system
considering the purpose of
the change and any
potential consequences, the
integrity of the quality
management system, and
any impacts on resources,
responsibilities and authorities
6 Evaluate the auditee’s
arrangements for the planning,
implementation and control of
operational processes, and
evaluate the effectiveness of
the arrangements in meeting
customer and applicable
statutory and regulatory
requirements

• These processes include the


determination and review of
requirements, design and
development, production,
service provision and
release, external provision
and nonconforming outputs
7 Evaluate the auditee’s
arrangements for monitoring,
measuring, analysis and
evaluation of the quality
management system
performance against policy and
planned objectives, including
requirements for internal audit.
8 Evaluate management review of
the suitability, adequacy and
effectiveness of the quality
management system

9 Evaluate the auditee’s


arrangements for continuous
improvement, including the
effectiveness of dealing with
nonconformity and corrective
action

10 Evaluate top
management’s
commitment to the quality
management system.

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QUALITY MANAGEMENT SYSTEM
ISO 9001:2015
Continuous Assessment

Day 4 – CA 7: Opening Meeting. (25 points)

The students will present the closing meeting by team and the tutor shall score the performance of
each students individually according to the following criteria:
Award 5 points for each criteria: 5 – Excellent, 4 – Very Good, 3 – Good, 2 – Needs Improvement, 1 –
Poor. - (25 points)

CRITERIA TUTOR’S EVALUATION


Sound presentation. The overall presentation of the opening meeting
and the equal and fair distribution of responsibilities to the audit
team members.
Group effort. The acknowledgement and acceptance of audit
assignments of the audit team members.
Individual contribution.
Individual presentation of the audit assignments.
Communication with the audit client. The presentation of activities and
actions of each audit team members and the auditee’s acceptance of the
activities.
Audit plan. The overall formation of the plan that includes person/s to
interview, location of the evidence, guide’s orientation, awareness in
company’s code of conduct, restrictions (if appropriate) and other
necessary information that needs to tackle before the start of audit
proper.

TUTOR’S SCORE

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ISO 9001:2015
Continuous Assessment

Day 4. CA 8. Auditing Quality Management System against ISO 9001 requirements. (20 points)

With reference to the Audit plan and checklist you previously prepared for the case study
documents of UPCL, Audit the documents, manual and procedures and write your findings and the
evidences on the form. (20 points). If it meets the requirement mark Y on C and X if NC.

SN FINDINGS C NC
1

4 a.

b.

c.

d.

5 a.

b.

c.

d.

e.

f.

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ISO 9001:2015
Continuous Assessment

10

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QUALITY MANAGEMENT SYSTEM
ISO 9001:2015
Continuous Assessment

Day 4. CA 9. Writing nonconformity: (30 points)


With the audit findings generated from Practical Auditing (CA 8) activity, write audit
summary report.

NON CONFORMITY REPORT

Report Number: Date:


Company Name:

NCR found in: Function/Department:

Minor Major Grade:

Auditor NON CONFORMITY DETAILS

Nonconformity statement

Objective evidence

Clause number and requirement

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QUALITY MANAGEMENT SYSTEM
ISO 9001:2015
Continuous Assessment

Day 5 - CA 10: Conducting Closing Meeting (25 points)

The students will present the closing meeting by team and the tutor shall score the
performance of each students individually according to the following criteria:

Award 5 points for each criterion: 5 – Excellent, 4 – Very Good, 3 – Good, 2 – Needs
Improvement, 1 – Poor. - (25 points)

CRITERIA TUTOR’S EVALUATION

Sound presentation. The overall presentation of the audit


conclusion including the recommendation for certification.

Group effort. Participation in reviewing audit finding against audit


objective, agreeing with audit conclusion, identifying follow-up
action and confirming appropriateness of audit program.

Individual contribution. Individual presentation of the generated


audit findings with identified nonconformity report (if any) and its
appropriate grading.

Communication of the audit process to the client including the


advice that collected audit evidence is based on sample
information, method of reporting, grading of findings and the plan
for correction and corrective action for any nonconformities.

Ability to handle situation when diverging opinions regarding the


audit findings or conclusions between audit team and the client
professionally

TUTOR’S SCORE

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ISO 9001:2015
Continuous Assessment

Day 5 – CA 11: Writing Audit Summary (10 pts.)

AUDIT SUMMARY REPORT


AUDITOR’S CLIENT:

AUDIT OBJECTIVE:

AUDIT CRITERIA:

Areas Of The Company Subject To Audit Activity

Conclusions (positive findings / main areas of weakness).

Overview of findings (areas of weakness of the company or requirements of ISO 9001).

Auditor’s recommendations about the company’s area of weakness.

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QUALITY MANAGEMENT SYSTEM
ISO 9001:2015
Continuous Assessment

Day 5: CA 12: Conduct a follow up audit. (10 points)

Function/Department Audited: Procurement Report No :


0355 Date Of Audit: 05/09/19
Auditor(S) : Mike Tyson

Nonconformity Details:

Training Record for A. Smith (Purchasing Dept.) contains no evidence of training received in use of
revised Purchasing database.

Training Plan for 200y indicates that such training is necessary and to be given to all staff within the
Purchasing Department. ISO 9001 6.2.2 / Company Procedure CPQ 021 paragraph 6.4

Acknowledge by: Jaja Jonn - Human Resource Manager

Correction Done:

Amanda Smith was on vacation at the time training was provided to purchasing staff. Subsequently
she received ‘one to one’ training from the senior buyer and the Information Technology department,
however this was not recorded in her training records. Training record form has been amended to
indicate date and adequacy of training outcome.

Corrective Action(S):

The current training and record keeping process is considered to be fully satisfactory,
however the ‘Annual appraisal form’ will be amended to require a listing of any training
received by an individual over the past twelve months in order to capture and record any
training that may have accidentally not been recorded in the normal way. (immediate action).

Acted By: Jaja Jonn - Human Resource Manager


Audit Management Agreement: Mark Blake

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. (10 points)

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QUALITY MANAGEMENT SYSTEM
ISO 9001:2015
Continuous Assessment

Tutor’s Assessment

Award points for each criterion – (25 points)


5 – Excellent, 4 – Very Good, 3 – Good, 2 – Needs Improvement, 1 – Poor

CRITERIA POINTS
Involvement, participation and contribution in class discussions. Reporting ability
and adaptability to different simulation.

Presentation of works, written assignments and support and contribution to group


activities.

Competence, skills, personal attributes and audit management capabilities.

Attitude, manner and suitability to become auditor and as audit team leader.

Attendance, punctuality and follow strictly the timing of the course.

TOTAL

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