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Learning Guide #17: Ethiopian TVET-System

apply quality standard lo4

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wesendesta0
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11 views

Learning Guide #17: Ethiopian TVET-System

apply quality standard lo4

Uploaded by

wesendesta0
Copyright
© © All Rights Reserved
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Ethiopian TVET-System

INFORMATION TECHNOLOGY
SUPPORT SERVICE
Level I

LEARNING GUIDE #17

Unit of Competence: Apply Quality Standards


Module Title: Applying Quality Standards
LG Code: ICT ITS1 M06 L04 LG-17
TTLM Code: ICT ITS1 TTLM07 1019v1

LO4: Study Causes of Quality


Deviations
Instruction Sheet Learning Guide # 25
This learning guide is developed to provide you the necessary information regarding the
following content coverage and topics –
 Causes of deviations from final products with workplace procedures
This guide will also assist you to attain the learning outcome stated in the cover page.
Specifically, upon completion of this Learning Guide, you will be able to –

 Investigate and report causes of deviations from final products in accordance with
workplace procedures
 Recommend suitable preventive action based on workplace quality standards and
identified causes of deviation from specified quality standards of materials or final
product

Learning Instructions:
1. Read the specific objectives of this Learning Guide.
2. Follow the instructions described below 3 to 6.
3. Read the information written in the information “Sheet 1, Sheet 2, Sheet 3 and
Sheet 4, Sheet 5 ” in page 3, 22, 29, 33 and 35 respectively.
4. Accomplish the “Self-check 1, Self-check t 2, Self-check 3 and Self-check 4, Self-
check 5 in page 16, 27, 32, 34 and 37 respectively.
5. If you earned a satisfactory evaluation from the “Self-check” proceed to
“Operation Sheet 1 in page 18.
6. Do the “LAP test” in page 20, 28.

Page 2|8 Author: Federal TVET IT Support Service Level 1 Date: Oct 2019
Agency(FTA) Version: 1
Information Sheet 1 Quality performance in workplaces
 A Standard Procedure for Quality Assurance Deviation Management
 What is a Deviation?
A Deviation is a departure from standard procedures or specifications resulting in
non-conforming material and/or processes or where there have been unusual or
unexplained events which have the potential to impact on product quality, system
integrity or personal safety.

 Types of Deviations:
Following are some examples of deviations raised from different functional areas
of business:-
 Production Deviation - usually raised during the manufacture of a batch
production.
 Quality Improvement Deviation - may be raised if a potential weakness
has been identified and the implementation will require project approval.
 Audit Deviation - raised to flag non-conformance identified during internal,
external, supplier or corporate audits.
 Customer Service Deviation - rose to track implementation measures
related to customer complaints.
 Technical Deviation - can be raised for validation discrepancies. For
example: changes in Manufacturing Instruction.
 Material Complaint - rose to document any issues with regards to non-
conforming, superseded or obsolete raw materials/components, packaging
or imported finished goods.
 System Routing Deviation - raised to track changes made to Bill of
materials as a result of an Artwork change.

 When to Report Deviation:


A Deviation should be raised when there is a deviation from methods or controls
specified in manufacturing documents, material control documents, standard
operating procedure for products and confirmed out of specification results and
from the occurrence of an event and observation suggesting the existence of a real
or potential quality related problems.
A deviation should be reported if a trend is noticed that requires further
investigation. All batch production deviations (planned or unintended) covering all
manufacturing facilities, equipments, operations, distribution, procedures, systems

Page 3|8 Author: Federal TVET IT Support Service Level 1 Date: Oct 2019
Agency(FTA) Version: 1
and record keeping must be reported and investigated for corrective and
preventative action.
Reporting deviation is required regardless of final batch disposition. If a batch is
rejected a deviation reporting is still required.

 Different Levels of Deviation Risks:


For the ease of assessing risk any deviation can be classified into one of the three
levels 1, 2 & 3 based on the magnitude and seriousness of a deviation.

 Level 1: Critical Deviation


Deviation from Company Standards and/or current regulatory expectations
that provide immediate and significant risk to product quality, patient safety
or data integrity or a combination/repetition of major deficiencies that indicate
a critical failure of systems.

 Level 2: Serious Deviation


Deviation from Company Standards and/or current regulatory expectations
that provide a potentially significant risk to product quality, patient safety or
data integrity or could potentially result in significant observations from a
regulatory agency or a combination/repetition of "other" deficiencies that
indicate a failure of system(s).

 Level 3: Standard Deviation


Observations of a less serious or isolated nature that are not deemed Critical
or Major, but require correction or suggestions given on how to improve
systems or procedures that may be compliant but would benefit from
improvement (e.g. incorrect data entry).

 How to Manage Reported Deviation:


The department Manager or delegate should initiate the deviation report by using
a standard deviation form as soon as a deviation is found. Write a short
description of the fact with a title in the table on the form and notify the Quality
Assurance department within one business day to identify the investigation. QA
has to evaluate the deviation and assess the potential impact to the product
quality, validation and regulatory requirement. All completed deviation
investigations are to be approved by QA Manager or delegate. QA Manger has to
justify wither the deviation is a Critical, Serious or Standard in nature. For a
deviation of either critical or serious nature QA delegate has to arrange a Cross
Functional Investigation. For a standard type deviation a Cross functional

Page 4|8 Author: Federal TVET IT Support Service Level 1 Date: Oct 2019
Agency(FTA) Version: 1
Investigation (CFI) is not necessary. Immediate corrective actions have to be
completed before the final disposition of a batch. Final batch disposition is the
responsibility of Quality Assurance Department.

 Workplace Prevention and Response


Workplace violence can be any act of physical violence, threats of physical
violence, harassment, pressure, or other threatening, disruptive behavior that
occurs at the work site. Workplace violence can affect or involve employees,
visitors, contractors, and other non-Federal employees.

 Responsibilities
It is up to each employee to help make a safe workplace for all of us. The
expectation is that each employee will treat all other employees, as well as
customers and potential customers, with dignity and respect. You can and should
expect management to care about your safety and to provide as safe a working
environment as possible by having preventive measures in place and, if necessary,
by dealing immediately with threatening or potentially violent situations which
occur.

 Prevention of Workplace Violence


A sound prevention plan is the most important and, in the long run, the least costly
portion of any agency’s workplace violence program.

 Identifying Potentially Violent Situations


If you ever have concerns about a situation which may turn violent, alert your
supervisor immediately and follow the specific reporting procedures provided by
your agency. It is better to err on the side of safety than to risk having a situation
escalate.
 Responding to Violent Incidents
No matter how effective agencies' policies and plans are in detecting and
preventing incidents, there are no guarantees against workplace violence. Even
the most responsive employers face this issue. When a violent incident does
occur, it is essential the response be timely, appropriate to the situation, and
carried out with the recognition that employees are traumatized and that the
incident’s aftermath has just begun.

 Disclosure of Information

Page 5|8 Author: Federal TVET IT Support Service Level 1 Date: Oct 2019
Agency(FTA) Version: 1
Disclosing information obtained from employees without their written consent. An
exception to this prohibition however, is if an employee specifically threatens
another person.

Page 6|8 Author: Federal TVET IT Support Service Level 1 Date: Oct 2019
Agency(FTA) Version: 1
Self-Check 1 Written Test

Name: _________________________________ Date: _________________________


Instruction: Answer all the questions listed below, if you have some clarifications- feel
free to ask your teacher.

Page 7|8 Author: Federal TVET IT Support Service Level 1 Date: Oct 2019
Agency(FTA) Version: 1
Experts

The development of this Learning Gide for the TVET Program Information technology
support service Level I.

No Name of Trainers Phone E-mail Address Region


Number
1 Abdulakim Ahemed 0921900418 Harari
2 Assefa Million 0911034866 [email protected] Harari
3 Derese Teshome 0913938439 [email protected] AA
4 Getenesh Osamo 0923816933 [email protected] SNNPR
5 Remedan Mohammed 0913478937 [email protected] Harari
6 Sewayehu W/Yohanes 0911716733 [email protected] SNNPR
7 Damelash Yihalem 0911912015 [email protected] Harari

Page 8|8 Author: Federal TVET IT Support Service Level 1 Date: Oct 2019
Agency(FTA) Version: 1

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