Creating a Document

1. Documents
and
Records
-
Module
16
1
Scenario
• Inspection Reports
• Quality Manual
• Audit Results
• Standard Operation
Procedures (SOPs)
• Summary of Audit
findings from on-site
Audits
• report of corrective actions
• Non conformances form
(blank form)
• Quality Control record (blank
form)
• Daily Maintenance log
(completed)
• Stock Cards and Stock Book
(completed)
• ETC
You have found all these papers lying on a
desk. Which of these are documents and
which are records?

2. Why do Organizations need to manage
documents and records?
To find information whenever it is needed!
 provides individuals with the information to
perform a job properly
 ensure permanence irrespective of personnel
change/turnover
 provide concise set of requirements
 facilitate consistency of quality activities
 facilitate monitoring activities and
 quality system audits
Documents
and
Records
-
Module
16
2

3. Why do Organizations need to
manage documents and records?
It minimizes opportunities for
miscommunication
When historical data are being evaluated for
current use, documents can also be valuable
 convey requirements simultaneously to all
concerned personnel
 facilitate effective change control
indicate compliance with organizational
governmental requirements
Documents
and
Records
-
Module
16
3

4. Documents
and
Records
-
Module
16
4
Documentsand Records—Howdo they differ?
ISO 9000:2005
Documents
 Information and the
supporting media
 communicate
information via policies,
processes, and
procedures
 need updating
Records
 Evidences of activities
performed
 capture information on
worksheets, forms,
labels, and charts
 permanent, do not
change
RECORDS

5. 5
Clarity index
Theclarityindexisameasureoftheeaseordifficultyofreading
apieceofwriting.Theprocessismechanicalandobjective.
CI = SL + LW%
SL - Average sentence length (total words/sent =15)
LW% - Percentage of long words ( ≤3 syllables =15)
(Sample approximately 200 words)
• CI>40 - text difficult to understand
• CI<20 - text abrupt & impolite
• CI~30 - typical conversation or press article
CHARACTERISTICS OF A DOCUMENT

6. Documents
and
Records
-
Module
16
6
Numbering System
•need uniform numbering system
•do not change a current system that
works one system:
•Org/Loc-Dept-Doc type-Serial number-
Rev status

7. Why Document Control
Documents
and
Records
-
Module
16
7
assures that the
most current
version is used
ensures availability
when needed
organizational tool

8. Documents
and
Records
-
Module
16
8
Common Document Control Problems
•outdated documents
•too many documents are
distributed and the system
cannot be maintained
•lack of control of documents
of external and internal origin
•Lack of a central control of
documents
•Lack of communication of
requirements

9. Policies
Processes
Procedures
Documents
and
Records
-
Module
16
9
Organisation
Documents

10. Documents
and
Records
-
Module
16
10
Policies - The “WHAT TO DO”
“A written statement of overall intentions and
directions defined by those in the organization and
endorsed by management.”
Policies:
tell “what to do” in a broad and general way
include the organizational mission, goals, and
purpose
serve as the framework for the quality system
should always be specified in the quality manual

11. Documents
and
Records
-
Module
16
11
Processes- The “HOWIT HAPPENS”
A “set of interrelated or interacting activities
that transform inputs into outputs.” (ISO
9000 4.3.1)
Processes:
• describe the steps involved to carry out quality
policies
• easily represented in flow charts
• involve a series of steps, usually occurring over a
period of time

12. Documents
and
Records
-
Module
16
12
Procedures- The “HOWTO DO IT”
Procedures, Standard operating procedures (SOP)
 step-by-step instructions for performing a single activity
Job aid
a shortened version of the SOP
does not replace the SOP
Work Instruction
a detailed version of the SOP
does not replace the SOP
Needed where more information is required

13. Documents
and
Records
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Module
16
13
Good Documents are:
•clear
•concise
•user-friendly
•explicit
•accurate
•up-to-date

14. 14
Documents for work processes should
be accessible to staff at the work site :
• instructions on performing activities
• SOPs required by Standard
• SOPs required by Organisation
• Quality manuals

15. Documents
and
Records
-
Module
16
15
Standard Operating Procedures
(SOPs) are documents that:
describe how to perform a activities using
step-by-step instructions
written SOPs help ensure:
•consistency
•accuracy
•quality

16. 16
Examples of Purpose:
This procedure defines the minimum steps required
for creation and control of information and documentation
for PRN in compliance with the requirements of
ISO 9001:2008 Quality Management System Standard.
To eliminate the cause of existing nonconformities in
order to prevent recurrence
To identify the method of accessing the legal and
other regulatory requirements applicable to
PRN’s operations and the up-date of the Register of
legal regulations requirements.

17. Documents
and
Records
-
Module
16
17
Document Preparation and
Control Process
Preparation
Review
Issue
Distribution
Revision Approval