Update and Document Operational Procedure-Final
Update and Document Operational Procedure-Final
Learning guide
Unit of Competence: Update and document operational procedure
Module Title : Updating and document operational procedure
LG Code : EISITS2 02 0710
TTLM Code : EISITS2 02 M0710
Review current version of technicaland user documentation based on the latest operational procedures.
Compare accuracy of technicaland user documentation with current systemfunctionality.
Identify and document inaccuracies for future reference.
Learning Activities
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.
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.
Documentation in ICT field: The following are different types of documentations usually seen in the ICT field.
1. User documentation - Designed for the end user of the computer hardware or software. It may not be a computer
specialist
Examples of user documentation
Instructional Materials which usually come with the hardware or software such as installation
instructions or a troubleshooting guide.
Training Materials designed to teach the user the skills required to use the hardware or software.
Examples include tutorials and user manuals.
Reference Materials designed so users can look up a particular task. An example is a quick reference
guide.
Policies and Procedures of an Organization. This documentation helps all staff and management work
to the same guidelines and rules.
2. Technical documentation- "Technical documentation" is the generic term for documentation with regard to a
product. People mainly associate the term with the documents and information that are passed on to the public by the
manufacturer.
It is also a documentation that is produced for a person who has enough expertise in a particular computer
system to support or maintain that system.
Examples of technical documentation
User instructions
Operating instructions
Servicing instructions
Installation manuals
Software manuals
The term 'technical documentation' refers to different documents with product-related data and information that are used
and stored for different purposes. “Different purposes” mean: Product definition and specification, design, manufacturing,
quality assurance, product liability, product presentation; description of features, functions and interfaces; intended, safe
and correct use; service and repair of a technical product as well as its safe disposal.
Instructions versus directions versus manual versus handbook versus …
Often, there is still confusion about whether something should be called operating instructions, user manual, user guide,
user directions, operating manual etc. pp. The standards for technical editors and the law makers are also not consistent in
their terminology. Let's try to sort it out from a linguistic point of view:
"Directions" is derived from "to direct": Here it is the superior who directs the subordinate, i.e. the boss directs the
staff member (or parents their child). Hence, user directions can only be given internally (within the company).
Accordingly, the user direction is the document that details the procedures for a specific workplace. It takes into
account the specific demands and requirements within the company. This makes it clear that user directions cannot be
supplied by the manufacturer of the product: the manufacturer has no knowledge of the company internals of the user.
"Instructions" is derived from "to instruct". Somebody capable of something already instructs someone else who
wants to learn just this. Here two entities meet eye-to-eye, e.g. manufacturer and user. Therefore, the instructions are
the document that communicates, how to employ and use the product. When "instructing" however, you do not really
Because writers come from all types of backgrounds, there may be problems within the documentation that need
to be fixed. Writers may be very knowledgeable in their subject areas but not great writers, or they may be excellent
writers but not completely fluent in the language of the document. The language review addresses these types of problems
by focusing on language issues that make the document easier for the user to read and understand. Some of the problems
that may occur within the document are poor sentence structure, grammar, organization, clarity, and spelling.
If you are doing a language review, you should be fluent in the language and the structure of the language. You
want to consider both the logic and grammar of the document. Your primary goal in a language review is to identify and
correct areas that could lead to confusion for the reader/user of the document. To this end, you can most certainly use
language and grammar references such as dictionaries and handbooks when in doubt.
I. MATCHING TYPE. Match the terms in Column B with the appropriate description in Column A.
COLUMN A COLUMN B
You can ask you teacher for the copy of the correct answer
This learning guide is developed to provide you the necessary information regarding the following content coverage and
topics
Review current version of technicaland user documentation based on the latest operational procedures.
Compare accuracy of technicaland user documentation with current systemfunctionality.
Identify and document inaccuracies for future reference.
Learning Activities
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.
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.
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, SOPs 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.
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
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.
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.
SOPs need to remain current-recent to be useful.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.
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.
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.
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.
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 – readformat.
________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.
_______________________ _______________________
III. IDENTIFICATION. Identify the term being described in each item. Write your answer in the space provided
before each item.
______________________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
Other terms used to mean operating procedures (protocols, instructions, worksheets, laboratory operating procedures)
1. (repititive)
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.
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: ________________________________________
_______________________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.
You can ask you teacher for the copy of the correct answer
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. 1.a. Concise b. step – by – step c. easy – to – read format
11. 1. A
2. C
3. B
4. C
5. A
6. B
Review current version of technicaland user documentation based on the latest operational procedures.
Compare accuracy of technicaland user documentation with current systemfunctionality.
Identify and document inaccuracies for future reference.
Learning Activities
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.
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.
A fundamental problem
• Whose fault is that? The users’ or the writers’?
Why don’t people read manuals?
• “No time.”
• “Can’t find what you are looking for.”
• “Can’t understand a thing.”
• “The instructions don’t work.”
• “What I want to do isn’t in the manual.”
Parts of a technical document as a package
• Divide the document into sections based on roles, for example, 'data entry' and 'administration'.
• Match the procedures to tasks. Group similar tasks into the same chapter.
• Organize chapters so that frequent tasks come before infrequent tasks.
• If you need both task-based instructions and reference material, divide the document into two sections. The first
section is a user guide. The second section is a reference manual. The user guide contains short procedural
information. It does not explain each field in each dialog box. Instead, it contains cross-references to the reference
section.
• You are an expert who knows the terms, the assumptions, and the shortcuts in the subject area. Do not make
logical jumps that non-experts do not understand. Possibly, you must 'state the obvious', because the audience
does not know the subject. However, do not give information that is not necessary. If one sentence is sufficient,
do not include a page of screen shots.
I. TRUE OR FALSE. Write True if the statement is correct, otherwise, write False.
___________1. Developers can review the usability of the documentation.
___________2. Documentation increases the support cost of the company.
___________3. Getting information from existing documentation is one way to find the tasks and the procedures
that people do.
___________4. In writing a user manual, you should assume that the user knows everything.
___________5. Multiple entry points should be created to access information in the user manual.
II. ENUMERATION. List down what are asked in each item.
1. Type of user documentation
_________________________ _________________________ _________________________
2. Reasons for producing documentation
_________________________ _________________________
_________________________ _________________________
You can ask you teacher for the copy of the correct answer