Documente Academic
Documente Profesional
Documente Cultură
MODULE CONTENTS
1. Assess technical and user documentation
2. Update procedure
3. Update documentation
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Information Sheet 1
2. Technical Documentation.
3. User Documentation.
4. System Documentation.
User documentation:
Designed for the end user of the computer hardware
or software.
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Examples of user documentation are manuals, on-line
help, wizards and on-line tutorials.
Technical documentation:
This is designed for the people responsible for
producing or maintaining the hardware or software.
Brainstorming Activity:
List as many types of techdocs as you can…….
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Instructional material – usually accompanies the
computer system, be it hardware or software, and
provides information on how to use the system or
particular aspects of it.
Media:
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Computer documentation is presented in a wide
range of forms, from the traditional paper books to
various computerised media. These media can
generally be divided into three groups:
Questions….
List at least 4 factors that need to be considered when
determining the medium?
What kind of needs may users have, which need to be
considered?
What does ‘appropriateness of the medium to the
task’ mean?
For Next time …
The Need
Technically correct document
Concise Information
Avoid Chaos/disorder
Timely Delivery
Satisfaction
Review Objectives
Evaluate the documented information
o Accuracy = Correctness
o Completeness = wholeness
o Conciseness = shortness
Reduce the defect percentage
Improve the quality of documents
Focus on correcting the defects
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Reviews
Peer Review
o Review by people who have coordinated
knowledge and skills.
Provide a list of exactly what you need them
to review
o Assess peer review practice
o Prepare procedure documents
o Formulate a program agenda
Presentation Review
Review amongst the technical writers
Subject matter expert review
Review for technical information
Overall Review
Review by the testing team for detecting defects.
Create Document
Accept or Reject
Comments
Communicate to the
reviewer
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reviewer
Update the document
reviewer
Review Focus
Before circulation
o Review the document for readability and
clarity.
o Review for correct English usage
o Review and evaluate the technical content
o Make a reviewers checklist
Focus on the technical review and not
on editorial review
Verify the technical accuracy of all
procedural steps.
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Verify the accuracy of all screen captures
in the document.
After review
o Review the sent checklist
o Take a positive approach
o Maintain a tracking list
o Decide and let the reviewer know which
comments would be incorporated
o Call a meeting if required.
o Publish the final copy.
Challenges
Involving Team (Let us do it)
Getting Proper reviews
Handling Last Minute Changes
INTRODUCTION
1.1 Overview
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An Operating Procedure (OP) is a set of written instructions that
document a routine or 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.
1.2 Purpose
OPs detail 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.
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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.
1.3 Benefits
SOP PROCESS
2.1 SOP Preparation
The organization should have a procedure in place for
determining what procedures or processes need to be
documented. Those SOPs 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” from potential users of the SOP.
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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 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
Update Procedure
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2. Double-click Add/Remove Programs, click Add New
Programs, and then click CD or Floppy.
3. Click Next.
4. Click Browse.
5. Locate the root folder of the Office source location, click
Setup.exe, and then click Open.
…..
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3. Update documentation
3.1. Review feedback.
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.
3.3 Text
1. Cite the other SOP and attach a copy, or reference where it may
be easily located.
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