How to Write Effective and

Efficient Procedures for Your

Quality Management System
To Ensure that You Maximize the
Results of Your Document
Generation Processes
Property of: Innovative Quality Services Company, Inc.
Chardon, Ohio
 Webinar Overview
I Overview and Agenda Preview
II Scope and Purpose
III Why are We Here? – Webinar Objectives
IV Background of Documentation
V Say What You Do
VI Do What You Say
VII Be Ready and Able to Prove It
VIII What’s Next – Action Items
IX Summary – Review - Objectives
 How to Write Effective and
Efficient Procedures for Your
Quality Management System
Presented by:
Michael A. Mathe
President – Innovative Quality Services Company, Inc.

Key presenter Mike Mathe

Webinar Scope and
Purpose

Scope

Purpose
 Workshop Objectives

Learn, understand and apply the “how to do” of
procedure writing.

Explain what makes a good procedure.

Define efficient procedures

Define effective procedures

Define inefficient documents

Explain how to analyze existing procedures and identify
ineffective processes.

Developing a moving forward action plan for your
procedure development activities
 Effective
 Defined as…
– Producing a desired effect
– The ability to meet stated requirements
– The ability to meet customer’s requirements
– The ability to meet the ISO 9001:2000 standard’s
requirements
 Efficient

 Defined as…
– Acting or producing effectively with a minimum
of waste, expense, or unnecessary effort.
– Exhibiting a high ratio of output to input.
 How to Write Effective and
Efficient Procedures
 Defined as…
– To formulate a systematic procedure development
plan that meets the (ISO) standard's requirements
while not overburdening the business management
system.
– To plan the procedure development process in a
manner that will create maximum results for your
organization.
 Inefficient
 Defined as…

Not efficient; unable to effect or achieve the
desired result with reasonable economy of
means.

Not producing the intended result; ineffective.

Wasteful of time, energy, or materials.

Not working or producing results etc. in the
best way and so wasting time, energy etc.
 Say What You Do
Documentation Structure
 Policy
 Procedures
 Work Instructions (when needed)
 Forms
 Say What You Do
Documentation Structure
 Control of documents
 Good practices can assist in developing useful
and user-friendly documents.
– These practices should include methods for: (see
next two slides)
 Say What You Do
Control of documents
 Approval of documents prior to issue
 Reviewing and updating documents when
necessary
 Identifying changes and current revision status
of documents
 Ensuring that relevant versions of documents
are available at points of use
 Say What You Do
Control of documents (continued)
 Ensuring that documents remain legible and
identifiable
 Controlling documents of “external origin”
and
 Preventing the unintended use of obsolete
documents
 Say What You Do
Documentation Structure
 How to write policies and procedures
 Say What You Do
Documentation Structure
 Purpose of procedure writing
 Procedures are instructions.
 They can range from simple to complex.
 Procedures help prove that you do what you
say you do for accreditation purposes.
 Say What You Do
Documentation Structure
 Purpose of procedure writing
 Help reduce human error
 Document best practices
 Provide a basis for auditing
 Assist workers in performing a task
 Helps to reduce human error
 Helps to ensure that tasks are performed in an
efficient and safe manner.
 Say What You Do
Documentation Structure
 Purpose of procedure writing
 Serve an administrative function – can also
provide a place to record information on the
process the procedure defines.
 If the procedure provides a place for data, a
date and a signature the procedure also
becomes a record.
 Say What You Do
Documentation Structure
 Defining a procedure
1.An act or a manner of proceeding in any action
or process; conduct.
2.A particular course or mode of action.
3.Any given mode of conducting legal,
parliamentary or other business.
 Say What You Do
Documentation Structure
 Defining a procedure
4.A series of steps taken to accomplish an end: a
medical procedure; evacuation procedures.
5.A set of established forms or methods for conducting
the affairs of an organized body such as a hospital,
business, club or governmental agency.
 Say What You Do
Documentation Structure
 Selecting which procedures to develop
1.Review your certification requirements and write
every procedure that your selected standard
requires.
2.Choose topics that are detailed.
3.Choose topics that are task specific.
 Say What You Do
Documentation Structure
 Selecting which procedures to develop
4.Choose topics that must be covered in training a new
employee.
5.When management requires more control over the way
tasks are performed.
6.When a process needs to be corrected to prevent future
errors (preventive actions).
 Say What You Do
Documentation Structure
 Selecting which procedures to develop
7.When it makes good common sense and good general
business practice to be consistent in the way a series of
tasks are carried out.

To minimize unplanned variability of the selected
process

To allow supervision to properly do their jobs
 Say What You Do
Documentation Structure
 Selecting which procedures to develop

EXERCISE
1.As an individual answer the following;
2.Determine reasons for selecting a procedure to write
3.Choose three topics for a procedure and develop a proper
title for each.
4.Complete this exercise after the Webinar if you need
more time
 Say What You Do
Documentation Structure
 Targeting the proper procedure users

 Write
procedures at a level of detail that is
appropriate for the procedures’ intended users.
 Say What You Do
Documentation Structure
 Targeting the proper
procedure users

 Write procedures to
ensure that the users
will benefit from their
use.
 Say What You Do
Documentation Structure
 Targeting the proper procedure users

 Besure to write procedures that can be

understood by management and supervision.
 Say What You Do
Documentation Structure
 Targeting the proper procedure users

 Besure to write procedures that can be

understood by Internal Auditors.
 Say What You Do
Documentation Structure
 Targeting the proper procedure users

 Besure to write procedures that can be

understood by customer and registration body
Auditors.
 Say What You Do
Documentation Structure
 Targeting the proper procedure users

 WARNING – Never write procedures just for

the sake of writing them; they will waste
valuable time.
 Say What You Do
Documentation Structure
 Use of syntax, vocabulary and punctuation
– Syntax is the way in which words are arranged.
– Follow the rules of English grammar.
(rules of how English ought to be written)
 Say What You Do
Documentation Structure
 Use of syntax, vocabulary and punctuation
– Essentialize
– Decide what you need to say and say it in as few
words as possible, but do not violate established
grammatical conventions by writing in a
“telegraphic” style.
 Say What You Do
Documentation Structure
 Use of syntax, vocabulary and punctuation
– Essentialize
– In The Elements of Style, Strunk and White, 1979 –
A sentence should contain no unnecessary words, a
paragraph no unnecessary sentences for the same
reason that a drawing should have no unnecessary
lines and a machine no unnecessary parts.
 Say What You Do
Documentation Structure
 Use of syntax, vocabulary and punctuation
– Write steps in imperative sentences.
– These begin with action verbs.
– They use the “active voice.”
– Write steps as positive commands.
– People prefer to deal with positive information
rather than negative thoughts and statements.
 Say What You Do
Documentation Structure
 Use of syntax, vocabulary and punctuation
– Break long sentences into several shorter
sentences.
– Shorter sentences contain fewer actions.
– Short sentences are easier to understand.
 Say What You Do
Documentation Structure
 Use of syntax, vocabulary and punctuation
– Use punctuation that conforms to standard
American English usage.
– Select a word order that minimizes the need for
punctuation.
– Use periods at the end of bullets if the bullets are
complete sentences.
– Use a colon to indicate that a list follows.
 Say What You Do
Documentation Structure
 Vocabulary
– Refers to word choice
– Procedures should use words that are easy to
understand and convey the correct meaning.
– Words should also be used consistently.
– A list of action verbs should be developed and
applied uniformly and consistently across each
procedure.
 Say What You Do
Documentation Structure
 Vocabulary
EXERCISE
1.As an individual, start by silently writing down
action verbs that are a part of your organization's
everyday vocabulary.
2.After this Webinar, get input from key co-workers
on this topic.
3.Develop a list of organizational action verbs that
need to be applied uniformly across all
procedures.
 Say What You Do
Documentation Structure
 Vocabulary
– Use short simple words that are common in our
everyday language.
– Accuracy is vital.
– Complex vocabulary has a strong negative effect
on readability.
– Avoid words that can be easily misunderstood.
– Substitute a clearer word if you have any doubt.
 Say What You Do
Documentation Structure
 Vocabulary
– Minimize the use of abbreviations and acronyms.
– Create a limited standard list (for when they are
needed) and choose from that list.
– Create a writer’s guide that includes this list.
 Say What You Do
Documentation Structure
 Deciding on which process steps to use
– Write your documents at a level of detail that is
appropriate for the target audience.
– Include all steps that, if not included, would
compromise the quality of the service that is being
provided.
 Say What You Do
Documentation Structure
 Deciding on which process steps to use
– The following section on Mapping Your Process
should help by shedding some more light on what is
the correct approach.
 Say What You Do
Documentation Structure
 Flowcharting (process mapping)
 Say What You Do
Documentation Structure
 How to write policies and procedures
– Flowcharting the process (aka: Process Mapping)

 Tool used to visually present information, data and

material flow within a process.
 Current-state process maps are created first.
 Maps can be evaluated to identify where waste exists
within the process.
 An Organization’s Processes
Inputs to Outputs from
Your Your
Your
Process Process
Process

 Supplier  Customer

Information
Information

Materials/Products

Quality
Materials/Products

Variation/Measurement

Equipment
Quality

People

Methods
Variation/Measurement

Environment
Constructing a Process Map
Symbols

The beginning or ending of the process

An activity or process step

A decision point

The direction of the process flow.

(Arrows cannot branch; they must have
one start and one stop point)
 Constructing a Process Map
 Guidelines
1. Process maps can represent the process as it is
actually being performed or as it would be performed
under ideal circumstances.

2. The following are supplemental process map symbols

A document that is either used in the

process or generated by the process.

A small circle with a letter indicates that

A this process map continues as the input
to another process map.

A large circle indicates an inspection of

process output.
 Constructing a Process Map

3. Process maps should be constructed by teams

knowledgeable about the process, in
cooperation with customers of and suppliers to
the process.

4. The boundaries of the process must be defined

and agreed upon by the team (i.e. start, finish,
inputs and outputs).
 Constructing a Process Map
1. What event(s), or triggers, represent the beginning
of the process you are mapping? Be as specific
as possible.
2. What event(s) mark the end of the process you are
mapping? Be as specific as possible.
3. Think sequentially. What actions do people take?
Where does the information come from? Where
does the information go?
4. Do the activities in the process occur without
interruption?
5. Who is typically involved? Who are the internal
suppliers and customers to the process at each step?
6. Do some events occur simultaneously?
7. Are there points in the process where performance
monitoring takes place? What is measured at
these points?
8. Does the process always work as designed? What
happens when there is a problem?
9. Where are the points in the process where decisions
are made?
10. What opportunities for improvement are indicated
as a by-product of the mapping process?
 Say What You Do
Process Map Exercise
1. As a Team, discuss a pertinent process that is
used at your organization.
2. Identify inputs and outputs.
3. Discuss where the process is monitored or
measured.
4. Create a draft process map.
 TQM
Total Quality Management
 Dilbert © by Scott
Adams www.dilbert.com
 Review and Approval

 Refer to your internal procedure development

procedure for detailed instructions.
 Identify process owners
 Identify process participants
 Determine if the document crosses over
departmental / supervisory boundaries.
 Review and Approval
 Determine a proper routing method (electronic,
hard copy or both).
 Assign responsibility for overseeing and
expediting the routing process.
 Create a feedback loop that is accessible to key
review participants to minimize
miscommunication and duplication of effort.
 Review and Approval
 Start the procedure on its way
 Pilot (test) the review process if possible to identify
and address process “bugs”
 Address the “bugs”, revise the process and roll out
the review and approval procedure steps
 Train – communicate to all involved to ensure that
you have an error free process
 Plan–Do–Check–Act Cycle
Also called: PDCA, plan–do–study–act (PDSA)
cycle, Deming cycle, Shewhart cycle

Description
The plan–do–check–act cycle (Figure 1) is a four-
step model for carrying out change. Just as a
circle has no end, the PDCA cycle should be
repeated again and again for continuous
improvement.

Plan-do-check-act cycle
 Procedure Revisions
 Refer to your internal procedure development
procedure for detailed instructions.
 Identify process owners
 Identify process participants
 Create a formalized method to bring revision
requests to your document control coordinator.
 Procedure Revisions
 Create a work in process draft copy of the
revised procedure and start to route as defined
in review and approval a new procedure.
 Create a feedback loop that is accessible to key
review participants to minimize
miscommunication and duplication of effort.
 Procedure Revisions

 Start the (draft revision) procedure on its way

 Pilot (test) the review process if possible to identify
and address process “bugs”
 Address the “bugs”, revise the process and roll out
the review and approval procedure steps
 Train – communicate to all involved to ensure that
you have an error free process
 Distribution and Accessibility of Your
Documents

 Refer to your internal document

control/procedure development procedure for
detailed instructions
 Refer back to our “best practices” for
document control
 Intranet data bases are the most practical,
accessible and if built properly error free.
 Distribution and Accessibility of Your
Documents

 Attempt to minimize hard copies “in float”.

 If hard copies are necessary, create a master
list and design a method of replacement and
recall for procedure revisions.
 Develop audit steps to ensure that the hard
copies are properly controlled.
 Distribution and Accessibility of Your
Documents

 Don’t provide copies to everyone in the

organization just for the sake of “minimizing
the distribution thought process”.
 Only provide copies (access) to those who
need to “use” the document in order to
determine, carry out, manage or audit the
process.
Distribution and Accessibility of Your
Documents

 Do ensure that access (copies) are made

available to those who need to use the
document during the course of a “normal”
work day.
 Always be sure that you use good common
sense when trying to answer any document
control best practices question.
 D.M.A.I.C.

Six Sigma Approach to

Process Improvement “DMAIC”

1. Identify Problem
Define
2. Map Process

3. Develop Analytical Approach Measure

4. Analyze Results (and Understand Root Analyze

Causes)

5. Identify Improvement Opportunities Improve

6. Develop Corrective Action Plan

7. Implement and Validate Results

8. Standardize and Internalize Control

Value Added Work - Essential in delivering the product
or service to the customer.
Three Characteristics

- Customer is willing to pay for the step

- It is done right the first time
- It changes the features, shapes, or form of the
product or service as the order is processed

Value Enhancing Work - Tasks that do not directly add

Business Value Adding value to the product or service,
but allow you to perform a key
value adding activity.

Non Value Added Work - Steps that the customer considers

non-essential to produce and/or
deliver the product or service.
The customer is not willing to
pay for this activity.

Required - Government or other regulatory

type requirements.
 Organizational Quality Improvement

Value Added Exercise

1. Review your organization today in regards to
a) Value added activities
b) Non-value added activities
2. Choose three NVA and
3. Discuss ways to minimize or eliminate them while
not sacrificing quality of product or service
provided to the customer
Continual Improvement
Procedures and Quality
Management
 Say What You Do
Documentation Structure
 Review of documents already developed by
your organization
Procedure Writing Success Stories
Don’t expect to hit a home run every time!
 Summary / Review
The choice will be entirely up to you.
ALOHA
Align your organization with the right approach to procedure writing.
Look for continual improvement opportunities as you develop your
documents.
Observe all aspects of your operations.
Harvest low-hanging process improvement opportunities as you review
what you currently do.
Apply those aspects of your standard that will generate adequate
payback for the effort given.
Questions
Answers
Discussion
Future Direction
 Bibliography / References / Credits / Sources

 Dilbertby Scott Adams

 WKYC TV 3 Cleveland, Ohio
 Procedure Writing Principles and
Practices,1998, Wieringa, Moore and Barnes