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OUALTY MANAGEMENT TRANNG PROGRAM

8O 8O
Document Document
Writing Writing
SO Document Writing Training 2
Objectives
Provide overview of the
documentation requirement of
ISO 13485
Demonstrate procedure writing
steps & tips
Share the proposed
documentation system for
InQpharm
QMS success & QMS success &
effectiveness is effectiveness is
from and for ALL from and for ALL
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ontent..
Documentation Defined...
ISO 13485 Documentation
Requirement
Process Approach
Procedure Writing
Documentation System
Q & A
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What ?
%erm Definition
Document
information and its supporting
medium
Procedure
specified way to carry out an activity
or a process (Note: Procedures can
be documented or not)
QuaIity ManuaI document specifying the QMS of an
organization
Record
document stating resuIts achieved or
providing evidence of activities
performed
Specification document stating requirements
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Why ?
ommunication of nformation
for information transmission and
communication.
Evidence of onformity
provision of evidence that what was
planned. has actually been done.
Knowledge 8haring
to disseminate and preserve the
organization's experiences. A typical
example would be a technical
specification. which can be used as a
base for design and development of a
new product.
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8O 13485 8O 13485
Documentation Documentation
Requirement Requirement
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4.0 Ouality Management 8ystem
4.1 General Requirements
Document. implement. maintain an
effective OM8.
dentify processes.
its application.
8equence & interaction
riteria & method for OM8 control are
effective
Provide resources & information {refer
section 6
Ensure MA {refer section 8
mplement actions to achieve planned result
& maintain effectiveness
Adequate control over outsourced processes.
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4.2 Documentation requirements
4.2.1 General
The organization needs to document
quality policy & quality objectives.
quality manual.
Documented Procedures as required {e.g design
project. order processing. purchasing. document
control. internal audit. supplier management.
customer complaints. training
Documents {records needed {e.g purchase orders.
sales contracts. inspection records. design review
notes. audit report. supplier contract etc..
Any others as required by national or regional
regulation
Technical file {DMR for each type of devices.
The quantity. detail. and form of the documentation
can differ from one organization to another depending
on size. type of activities. or complexity of processes.
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4.2.2 Ouality manual
The quality manual describes;
extent of OM8 and exclusion with justification
procedures {included/referenced
Business process map
4.2.3 ontrol of documents
Written Procedure on documents control {that requires
procedures are legible. identified. reviewed.
authorized. up-to-date. issued. distributed. and
periodically updated
Obsolete documents to be identified and protected
from unintended use.
External origin Documents identified and controlled.
4.2.4 ontrol of records
records to demonstrate/evidence OM8 operation
legible. and easy to identify and retrieve.
Written procedure on records control {records are
identified. stored. protected. retrievable. and define
their retention and disposal times
Process Approach
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What is What?
Process ~ A sef of inferreIofed or
inferocfinq ocfivifies which fronsforms
inpufs info oufpufs.
Procedure ~ Specified woy fo corry ouf on
ocfivify or o process (moy be documenfed)
Product ~ PesuIfs of o process
Effectiveness ~ AbiIify fo ochieve desired
resuIfs.
Efficiency ~ Meosure of resuIfs ochieved
versus pIonned resources.
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Process Training What is your Business?
nput Process Output
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The Process
INPU%
ncIudes Pesources
PROCESS
Sef of inferreIofed or
inferocfinq processes
OU%PU%
PesuIfs of o Process
What is a Process?
set of interrelated or interacting
activities which transform inputs into
outputs
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The Process
ISO 134b:Z003 stresses the importunce
to identify, impIement, munuqe & muintuin
effectiveness of the whoIe processes in
order to uchieve the compuny ob|ectives
Inputs und Outputs muy incIude
equipment, muteriuIs, components,
enerqy, informution & finunciuI
resources, umonq others
INPU%s and OU%PU%s
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Process then Procedure
1. 1. You are the owner of a coffee shop. You are the owner of a coffee shop.
2. 2. You require a PROCESS. You require a PROCESS.
3. 3. %hen you require a PROCEDURE for a cup of %hen you require a PROCEDURE for a cup of
Coffee. Coffee.
What are your inputs from the customer?
What do you need for the coffee?
How do you fiII the order?
What is the finaI product?
Some Questions you may wish to ask yourseIf (among others)
EXERCISE
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Where does it fit In ?
What other processes are invoIved?
Effectiveness ~ AbiIify fo ochieve desired resuIfs.
Efficiency ~ Meosure of resuIfs ochieved versus pIonned resources.
Feedbuck Specificution
Hof Wuter Coffee Disputch
Purchusinq
Inspection
Trunsport
Troininq
PIunninq
ReIeuse
Improvement
Monitorinq
Process then Procedure EXERCISE
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ORDER(Customer Input)
Cup
*Hot Wuter
Coffee
Suqur
MiIk
Spoon
MANUFACTURE
HoId Cup
Add wuter
Add Coffee
Add Suqur
Add MiIk
Stir
RECEIPT(Customer
Feedbuck)
A Stundurd Cup of
Coffee
Customer Feedbuck
Specificution
Instruction Product
onofher procedure wifhin our fociIify
MAKING a CUP of COFFEE
Procedure {low detail
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ORDER(Customer Input)
1 Zb0 mI cup
Z *Hot Wuter
3 Stundurd Coffee
4 rown Suqur
b FuII Creum MiIk
Teu Spoon
MANUFACTURE
1 HoId Cup
Z Pour Wuter
3 1 tsp Coffee
4 Z tsp Suqur
b Dush of MiIk
Stir 4
RECEIPT(Customer Feedbuck)
1 A Stundurd Cup of
Coffee
Z At the TubIe
3 After Dinner
4 Customer Feedbuck
form
HAT 7
HO 7 HEM7 HEPE 7
How Much DetaiI Is Required?
onofher procedure wifhin our fociIify
Procedure {high detail
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How Much DetaiI Is Required?


Procedure {no detail
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Define the Process,
DetaiI the %raining of operators,
Provide Resources, (tooIs etc)
Define Criteria/Methods to operate/controI the
process,
Define how the Process wiII be Measured,
Define how the Performance wiII be
Monitored.
What Now?
Managing The
Process
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Is your Procedure Effective? Is your Procedure Effective?
How do you Monitor it? How do you Monitor it?
How do you Measure it? How do you Measure it?
Can you Improve it? Can you Improve it?
Is It Effective? Can You Improve It? Monitoring The Process
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Remember l Remember l
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IDENTIFY
INPUT,
OUTPUT &
OBJECTIVE METRIC ?
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PROCEDURE PROCEDURE
WRI%ING WRI%ING
%%(techniques) (techniques) & & %%(tips) (tips)
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8O 9000 Procedure Writing
nformation
intent of the procedures are to be
used as a reference where they will
provide guidance and consistency
when employees perform quality
related tasks.
Responsibilities for Procedures:
Each department must be
responsible for writing their
procedures.
Managers for the departments have
approval of all procedures under
their areas of responsibility.
QMS success & QMS success &
effectiveness is effectiveness is
from and for ALL from and for ALL
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Requirements of Procedures:
Procedures are to be of document
control. {numbered. revision. signed
& dated
Procedures should reference inner-
related procedures and quality
system documentation created from
following the procedure.
Ouality Records as required by the
8O standard that are generated by a
procedure must be controlled {e.g by
form control process
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Procedures should specify:
What should be done?
Who will do it?
When will it be done and in what
sequence?
How will it be done?
What equipment. tools or materials
will be used?
What forms or other documents will
be used.?
An appendix for all forms used in the
procedure
A flow chart for the procedure {where
applicable - the flow chart can be the
procedure if it is understandable
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Procedures should specify:
8igned. dated authorizations under
revision control with controlled
distributions.
Other considerations to incorporate in
procedures:
Definitions
Referencing standards
8afety or danger warnings related to
the procedure
Documentation
Ouality Records
The Bottom Line:
For 8O. the bottom line is to write what
you do. then do what you have
written.
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Tips on Procedures:
1: The more general the procedure. the more
flexible. however. the more specific the
guidance. for those responsible for carrying
out job duties. the easier the system is to
maintain.
2: There must be at least one procedure for
each element for the standard. dependant
upon complexity of the element. Writing
separate procedures for manageable
activities will be less confusing than one
grand activity.
3: A reference can be put into the procedures
referencing other procedures if you are
documenting the elements other than by the
8O 8tandard numbering scheme.
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Tips on Procedures:
4: Try to keep the procedures from being
to specific. Assign who {by job title
does a task & when does it happen.
5: When assigning responsibility. use of
designee of person responsible in the
process will keep the process flexible &
provide an option should the responsible
person be unavailable at any specific
time
6: Keep the use of symbols minimized.
7: There must be consistency in action.
8: Use of a flow chart is highly
recommended.
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Avoid Drowning in
Detail...
The purpose of this procedure is to
document the aforementioned activities,
herin after referred to as the prescribed
tasks in terms that preclude their
execution in an inconsistent manner,
wherin such inconsistency may
potentially result in the prescribed tasks
delivering a result that is not repeatable
or reproducible
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Make procedures
user friendly
Use short sentences starting
with a verb.
Avoid using the passive voice.
Make it clear who is performing
the task.
Use white space for easy
reading.
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Documentation
Too Much? Too
Little?
Too Much:
Work instructions written for
virtually everything
Overlap and repetition - ncluding a
process in more than one work
instruction.
Too little:
Lack of work instructions resulting
in inconsistent processes and
quality of the product.
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Documentation
Remember that the goal here is
consistency for your processes.
f two trained employees were
to perform this task. would they
do it the same way?
f the answer to this is Maybe
not" a work instruction is
appropriate.
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Departments that
are Different"
Do you have a department that
needs artistic license" to do
their work?
You may encounter some
resistance to documenting
procedures in these areas.
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Help them see how the
procedure can work for them.
t is important to demonstrate to
these departments that the
process should be consistent.
The creativity takes place
within the process.
Document the procedure to
describe the steps that must be
followed. but not to prescribe
the detail of their job.
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OM8 OM8
DOUMENTATON DOUMENTATON
8Y8TEM 8Y8TEM
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QMS success & QMS success &
effectiveness is effectiveness is
from and for ALL from and for ALL
SO Document Writing Training 39
Determine individual processes. input.
output & objective metric {to be
forwarded
Establish work flow. write procedures.
train and records {those mandatory for
8O. ready for review by end Aug 05 l
8upport OM8
Ensure appropriate control. monitor &
improve
Always in ready mode
QMS success & QMS success &
effectiveness is effectiveness is
from and for ALL from and for ALL
SO Document Writing Training 40
O & A O & A
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