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LO4 Apply Quality Control

LO4 Apply Quality Control

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12 views

LO4 Apply Quality Control

LO4 Apply Quality Control

Uploaded by

birhanugirmay559
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Training, Teaching and Learning Materials Development

NAME OF INSTITUTION
UNDER

Ethiopian TVET-System
DATABASE ADMINISTRATION

Level III

LEARNING GUIDE # 42

Unit of Competence: Apply Quality


Control
Module Title: Applying Quality
Control
LG Code: ICT DBA3 M11 LO4
TTLM Code: ICT DBA3 TTLM 0817

Learning guide 42 Date 08-2017 Page 1 of 7


Author: IT Experts
Training, Teaching and Learning Materials Development

LO4: Study causes of quality deviations


LO4- Study causes of quality
Information Sheet-1 deviations

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
 Suitable preventive action based on workplace quality standards

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 –

 Causes of deviations from final products are investigated and


reported in accordance with workplace procedures
 Suitable preventive action is recommended based on workplace
quality standards and identified causes of deviation from specified
quality standards of materials or final product

Learning Activities

1. Read the specific objectives of this Learning Guide.


2. Read the information written in the “Information Sheet 1”.
3. Accomplish the “Self-check 1” in page 5.
4. Submit your accomplished Self-check 1. This will form part of your
training portfolio.
5. Read the information written in the “Information Sheet 2”.
6. Accomplish the “Self-check 2” in page 7.
8. Submit your accomplished Self-check 2. This will form part of your
training portfolio

Learning guide 42 Date 08-2017 Page 2 of 7


Author: IT Experts
Training, Teaching and Learning Materials Development

Causes of deviations from final products with


Information Sheet – 1 workplace procedures

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:

1. Production Deviation - usually raised during the manufacture of a


batch production.
2. Quality Improvement Deviation - may be raised if a potential
weakness has been identified and the implementation will require project
approval.
3. Audit Deviation - raised to flag non-conformance identified during
internal, external, supplier or corporate audits.
4. Customer Service Deviation - rose to track implementation measures
related to customer complaints.
5. Technical Deviation - can be raised for validation discrepancies. For
example: changes in Manufacturing Instruction.

Learning guide 42 Date 08-2017 Page 3 of 7


Author: IT Experts
Training, Teaching and Learning Materials Development

6. Material Complaint - rose to document any issues with regards to non-


conforming, superseded or obsolete raw materials/components,
packaging or imported finished goods.
7. 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 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).

Learning guide 42 Date 08-2017 Page 4 of 7


Author: IT Experts
Training, Teaching and Learning Materials Development

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 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.

Learning guide 42 Date 08-2017 Page 5 of 7


Author: IT Experts
Training, Teaching and Learning Materials Development

Suitable preventive action based on


Information Sheet – 1 workplace quality standards

Workplace Prevention and Response

1. Workplace Violence

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.

2. 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.

3. 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.

4. 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.

5. 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

Learning guide 42 Date 08-2017 Page 6 of 7


Author: IT Experts
Training, Teaching and Learning Materials Development

situation, and carried out with the recognition that employees are
traumatized and that the incident’s aftermath has just begun.

6. Disclosure of Information

Disclosing information obtained from employees without their written


consent. An exception to this prohibition however, is if an employee
specifically threatens another person.

Learning guide 42 Date 08-2017 Page 7 of 7


Author: IT Experts

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