Update and Document Operational Procedures date

Ethiopian TVET-System

INFORMATION TECHNOLOGY SUPPORT SERVICE

Level II

LEARNING GUIDE # 7

Unit of Competence : Update and Document

Operational Procedures
Module Title : Updating and Documenting
Operational Procedures
LG Code : ICT ITS2 M02 L02 07
TTLM Code : ICT ITS2 TTLM02 0516

LO 2: Updating Operational Procedures

Introduction Learning Guide #7

This learning guide is developed to provide you the necessary information regarding the
following content coverage and topics –

 User and Technical Documentation Review

 Accuracy Review of Technical and User Documentation

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 –

 Review current version of technical and user documentation based on the latest
operational procedures.
 Compare accuracy of technical and user documentation with current system functionality.
 Identify and document inaccuracies for future reference.

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Learning Activities

1. Read the specific objectives of this Learning Guide.

2. Read the information written in the “Information Sheets 1” in pages 3-6.
3. Accomplish the “Self-check” in pages 7.
4. If you earned a satisfactory evaluation proceed to “Information Sheet 2”. However, if your
rating is unsatisfactory, see your teacher for further instructions or go back to Learning
Activity # 1.
5. Read the information written in the “Information Sheet 2” in pages 8-11.
6. Accomplish the “Self-check” in page 12.
7. If you earned a satisfactory evaluation proceed to “Lap Test”. However, if your rating is
unsatisfactory, see your teacher for further instructions or go back to Learning Activity # 2.
8. Do the “LAP test” on page 13 (if you are ready) and show your output to your teacher. Your
teacher will evaluate your output either satisfactory or unsatisfactory. If unsatisfactory, your
teacher shall advice you on additional work. But if satisfactory you can proceed to Learning
Guide 7.

 Your teacher will evaluate your output either satisfactory or unsatisfactory. If

unsatisfactory, your teacher shall advice you on additional work. But if satisfactory you
can proceed to the next topic.

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Information Sheet 1 Updating Operational Procedures

Operational Procedures

An Operating Procedure (OP) is a set of written instructions that document a routine on

repetitive activity followed by an organization. The development and use of Ops are an integral
part of a successful quality system as it provides individuals with the information to perform a
job properly, and facilitates consistency in the quality and integrity of a product or end-result.

The term “OP” may not always be appropriate and terms such as protocols, instructions,
worksheets, and laboratory operating procedures may also be used. For this document “OP” will
be used.

Purpose

OP details the regularly recurring work processes that are to be conducted or followed
within an organization. They document the way activities are to be performed to facilitate
consistent conformance to technical and quality system requirements and to support data quality.

They may describe, for example, fundamental programmatic actions and technical actions
such as analytical processes, and processes for maintaining, calibrating, and using equipment.
OPs are intended to be specific to the organization or facility whose activities are described and
assist that organization to maintain their quality control and quality assurance processes and
ensure compliance with governmental regulations.

If not written correctly, SOP (Standard Operating Procedure)s are of limited value. In
addition, the best written SOPs will fail if they are not followed. Therefore, the use of SOPs
needs to be reviewed and re-enforced by management, preferably the direct supervisor. Current
copies of the SOPs also need to be readily accessible for reference in the work areas of those
individuals actually performing the activity, either in hard copy or electronic format, otherwise
SOPs serve little purpose.

Benefits

The development and use of SOPs minimizes variation and promotes quality through
consistent implementation of a process or procedure within the organization, even if there are
temporary or permanent personal changes. SOPs can indicate compliance with organizational
and governmental requirements and can be used as a part of a personnel training program, since
they should provide detailed work instructions. It minimizes opportunities for miscommunication
and can address safety concerns.

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Writing Styles
SOPs should be written in a concise, step-by-step, easy-to-read format. The information
presented should be unambiguous and not overly complicated. The active voice and present verb
tense should be used. The term "you" should not be used, but implied. The document should not
be wordy, redundant, or overly lengthy. Keep it simple and short. Information should be
conveyed clearly and explicitly to remove any doubt as to what is required.
Also, use a flow chart to illustrate the process being described. In addition, follow the style guide
used by your organization, e.g., font size and margins.

SOP PROCESS

SOP Preparation
The organization should have a procedure in place for determining what procedures or
processes need to be documented. Those OPs should then be written by individuals
knowledgeable with the activity and the organization's internal structure. These individuals are
essentially subject-matter experts who actually perform the work or use the process.
A team approach can be followed, especially for multi-tasked processes where the
experiences of a number of individuals are critical, which also promotes “buy-in”/interest from
potential users of the SOP.

SOPs should be written with sufficient detail so that someone with limited experience with
or knowledge of the procedure, but with a basic understanding, can successfully reproduce the
procedure when unsupervised. The experience requirement for performing an activity should be
noted in the section on personnel qualifications. For example, if a basic chemistry or biological
course experience or additional training is required that requirement should be indicated.

Write OP on how to uninstall software from your XP computer

SOP Review and Approval

SOPs should be reviewed (that is, validated) by one or more individuals with appropriate
training and experience with the process.It is especially helpful if draft SOPs are actually tested
by individuals other than the original writer before the SOPs are finalized.

The finalized SOPs should be approved as described in the organization’s Quality

Management Plan or its own SOP for preparation of SOPs. Generally the immediate supervisor,
such as a section or branch chief, and the organization’s quality assurance officer review and
approve each SOP. Signature approval indicates that an SOP has been both reviewed and
approved by management.

Frequency of Revisions and Reviews

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SOPs need to remain current-recent to be use full.Therefore, whenever procedures are changed, SOP
should be updated and re-approved. If desired, modify only the pertinent section of an SOP and indicate the
change date/revision number for that section in the Table of Contents and the document control notation

SOPs should be also systematically reviewed on a periodic basis,e.g. every 1-2 years, to ensure that the
policies and procedures remain current and appropriate, or to determine whether the SOPs are even needed. The
review date should be added to each SOP that has been reviewed. If an SOP describes a process that is no longer
followed, it should be withdrawn from the current file and archived.

The review process should not be overly cumbersome-burdensome to encourage timely review. The
frequency of review should be indicated by management in the organization’s Quality Management Plan. That
plan should also indicate the individual(s) responsible for ensuring that SOPs are current.

Document Control
Each organization should develop a numbering system to systematically identify and label their SOPs,
and the document control should be described in its Quality Management Plan.

Generally, each page of an SOP should have control documentation notation, similar to that illustrated
below. A short title and identification (ID) number can serve as a reference designation. The revision number and
date are very useful in identifying the SOP in use when reviewing historical data and is critical when the need for
evidentiary records is involved and when the activity is being reviewed. When the number of pages is indicated,
the user can quickly check if the SOP is complete. Generally this type of document control notation is located in
the upper right-hand corner of each document page following the title page.

SOP Document Tracking and Archival

The organization should maintain a master list of all SOPs. This file or database should indicate the SOP
number, version number, date of issuance, title, author, status, organizational division, branch, section, and any
historical information regarding past versions. The QA Manager (or designee) is generally the individual
responsible for maintaining a file listing all current quality-related SOPs used within the organization. If an
electronic database is used, automatic “Review SOP” notices can be sent. Note that this list may be used also
when audits are being considered or when questions are raised as to practices being followed within the
organization.

Short Title/ID #
Rev. #:
Date:
Page 1 of

As noted above, the Quality Management Plan should indicate the individual(s) responsible for assuring
that only the current version is used. That plan should also designated where, and how, outdated versions are to
be maintained or archived in a manner to prevent their continued use, as well as to be available for historical data
review.

Electronic storage and retrieval mechanisms are usually easier to access than a hard-copy document
format. For the user, electronic access can be limited to a read-only format, thereby protecting against
unauthorized changes made to the document.

Submit procedure
Prepare standard procedure for installation of programs from CD/DVD on Windows 7 System.

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SOP GENERAL FORMAT

SOPs should be organized to ensure ease and efficiency in use and to be specific to the organization
which develops it. There is no one “correct” format; and internal formatting will vary with each organization and
with the type of SOP being written. Where possible break the information into a series of logical steps to avoid a
long list. The level of detail provided in the SOP may differ based on, e.g., whether the process is critical, the
frequency of that procedure being followed, the number of people who will use the SOP, and where training is
not routinely available. A generalized format is discussed next.

 Title Page
The first page or cover page of each SOP should contain the following information: a title that clearly
identifies the activity or procedure, an SOP identification (ID) number, date of issue and/or revision, the name of
the applicable agency, division, and/or branch to which this SOP applies, and the signatures and signature dates
of those individuals who prepared and approved the SOP. Electronic signatures are acceptable for SOPs
maintained on a computerized database.

 Table of Contents
A Table of Contents may be needed for quick reference, especially if the SOP is long, for locating
information and to denote changes or revisions made only to certain sections of an SOP.

 Text
Well-written SOPs should first briefly describe the purpose of the work or process, including any
regulatory information or standards that are appropriate to the SOP process, and the scope to indicate what is
covered. Define any specialized or unusual terms either in a separate definition section or in the appropriate
discussion section. Denote what sequential procedures should be followed, divided into significant sections; e.g.,
possible interferences, equipment needed, personnel qualifications, and safety considerations (preferably listed in
bold to capture the attention of the user). Finally, describe next all appropriate QA and quality control (QC)
activities for that procedure, and list any cited or significant references.

As noted above, SOPs should be clearly worded so as to be readily understandable by a person

knowledgeable with the general concept of the procedure, and the procedures should be written in a format that
clearly describes the steps in order. Use of diagrams and flow charts help to break up long sections of text and to
briefly summarize a series of steps for the reader.

Attach any appropriate information, e.g., an SOP may reference other SOPs. In such a case, the following
should be included:
1. Cite the other SOP and attach a copy, or reference where it may be easily located.
2. If the referenced SOP is not to be followed exactly, the required modification should be specified in the
SOP at the section where the other SOP is cited.

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Self – Check Answer Key

Name: ______________________________________ Date:

________________________________________

I. TRUE OR FALSE. Write True if the statement is correct and write False if it is
incorrect. Write your answer in the space provided before each item.(10 points)

________1. OPs are intended to be specific to the organization or facility whose activities
are described.
________2. The information presented in SOPs should be ambiguous and overly
complicated.
________3. “YOU” can be freely used in SOP to address the instruction to the reader.
________4. Current copies of SOPs should be readily accessible for reference in the work
areas.
________5. SOP should be updated and re-approved whenever there are changes in any of
the procedures of the organization.
________6. During revision, the whole SOP should be revised.
________7. An OP should be written by an individual who has a little knowledge about the
activities and the organization’s internal structure.
________8. It is especially helpful if draft SOPs are actually tested by the original writer
before it can be finalized.
________9. SOP should be written in concise, step – by – step, easy – to – read format.
________10. Quality Management Plan is responsible for maintaining a file listing of all
current quality-related SOPs used within the organization.

II. ENUMERATION. Give what is/are asked in each item.

1. Other terms for OP

_______________________ _______________________
_______________________ _______________________

2. Instances where OP fails

_______________________ _______________________

3. Information indicated in the Title Page

_______________________ _______________________
_______________________ _______________________

III. IDENTIFICATION. Identify the term being described in each item. Write your answer
in the space provided before each item.

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______________________1. An operating procedure is a set of written instructions that

document a routine on what activity of the organization?
______________________2. What happens to the best written SOP when not followed?
______________________3. It indicates the frequency of review and the individual responsible
for ensuring that SOPs are current.
______________________4. Used as quick reference especially for long SOPs.
______________________5. Who is responsible for maintaining a file listing all current
quality-related SOPs used within the organization?

Note: Satisfactory rating - 20 points Unsatisfactory - below 20 points

You can ask you teacher for the copy of the correct answer
Other terms used to mean operating procedures (protocols, instructions, worksheets, laboratory
operating procedures)
1. (repetitive)
2. fail)
3. When do SOPs of limited value? (not written correctly, not followed)
4. Are OPs specific to an organization? true
5. Current copies of SOPs should be readily accessible for reference in the work areas (hard
copy or electronic format). (true)
6. SOP should be written in what format? (concise, step – by – step, easy – to – read)
7. What kind of voice should be used in writing SOP? (active)
8. The information in the SOP should be conveyed ___________ and ______________ to
remove doubt as to what is required. (clearly, explicitly)
9. It is used by the organization to have consistent format on font size, margins and other
format styles. (style guide)
10.What term should not be used in SOP because it is already implied?
11.An OP should be written by an individual who has a little knowledge about the activities
and the organization’s internal structure.

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12.What approach can be followed especially for multi-tasked processes because the
experiences of a number of individuals are critical? (team)
13.It is especially helpful if draft SOPs are actually tested by the original writer before it can
be finalized.(False)
14.Who review and approve SOPs (immediate supervisor, section or branch chielf, QA
officer)
15.Indicates that an SOP has been both reviewed and approved by management. (signature of
approval)
16.SOP should be updated and re-approved whenever there are changes in any of the
procedures of the organization.
17.During revision, it is possible to modify only specific section and not the whole SOP.
18.It indicates the frequency of review and the individual responsible for ensuring that SOPs
are current. (Quality Management Plan)
19.What are the considerations in the review and revision process of SOP? (SOPs need to
remain current-recent to be useful, SOPs should be also systematically reviewed on a
periodic basis, The review process should not be overly cumbersome-burdensome)
20.Who is responsible for maintaining a file listing all current quality-related SOPs used
within the organization? QA Manager
21.What are the information written in the Title page (title, an SOP identification (ID)
number, date of issue and/or revision, the name of the applicable agency, division, and/or
branch to which this SOP applies, and the signatures and signature dates of those
individuals who prepared and approved the SOP)
22.It is information in the title page that clearly identifies the activity or procedure.
23.Used as quick reference especially for long SOPs.

Self – Check Updating Operational Procedures

Name: ______________________________________ Date:

________________________________________

I.IDENTIFICATION. Identify the term described in each item. (10 points)

_______________________1. A set of written instructions that document a routine on repetitive

activity followed by an organization.
_______________________2. The development and use of SOPs can minimize what factor in
the implementation of a process or procedure within the
organization.
_______________________3. What tense of the verb should be used when writing SOP?
_______________________4. It is used to illustrate the processing described.

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_______________________5. It indicates that an SOP has been reviewed and approved by the
management.
_______________________6. The typical length of time (number of years) to review SOP.
_______________________7. Generally, the one responsible for maintaining a file listing all
current quality-related SOPs used within the organization.
_______________________8. Contains the list of SOP contents and the corresponding page
number in the manual.
_______________________9. Contains the description of the work or process.
_______________________10. It means that the SOP is updated.

II. ENUMERATION: Enumerate the items asked in each item. (10 points)
1. The three characteristics of SOPs, in terms of how it should be written.

_______________________________ _______________________________
_______________________________
2. Give four (4) important information that should be indicated in the master list of SOP.

_______________________________ _______________________________
_______________________________ _______________________________
3. Three(3) main parts of an SOP

_______________________________ _______________________________
_______________________________
III.Identify the following items as to what SOP process it belongs. Write A if it is an activity
in the SOP Preparation, B if it is in SOP Review and Approval or C if in the SOP
Document Tracking an Archival. (6 points)
_____1. Identify the procedures / processes need to be documented.
_____2. The Quality Management Plan should indicate the individuals responsible for
assuring that only the current version is used.
_____3. SOPs need to remain current – recent to be useful.
_____4. The organization should maintain a master list of all SOPs.
_____5. Team members / an individual should be identified who will be responsible to
write the SOP.
_____6. The review process should not be overly cumbersome – burdensome.

Note: Satisfactory rating - 12 points Unsatisfactory - below 12 points

You can ask you teacher for the copy of the correct answer

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Self – Check Answer Key

I. IDENTIFICATION
1. SOP
2. Variation
3. Present tense
4. Flowchart
5. Signature of approval
6. 1-2 years
7. QA manager
8. Table of Contents
9. Text
10.Current – recent
II. 1.a. Concise b. step – by – step c. easy – to – read format
2. a. short title / ID # b. Rev # c. Date d. Page number
3. a. title b. table of contents c. text

III. 1. A
2. C
3. B
4. C
5. A
6. B

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