Process Mapping and ProcessBased Internal Audits
Presented by Shannon Craddock of
Perry Johnson Registrars, Inc.
September 21, 2011
Todays Topics
Why
Are We Doing This?
Process Terminology
Process Mapping Symbols
Different Ways to Visualize a Process
Bakeries: A Practical Example
Process Approach to Auditing
Why Are We Doing This?
Outcomes
should matter to certified organizations and to
bodies, such as PJR, offering accredited certification.
Some
organizations get certified because of customer
mandates or to fly the flag.
There is a push for certification bodies to not just look for
conformity to requirements but for clear measures of true
process improvement.
After all, shouldnt organizations derive benefit from accredited
certification?
Outcomes Matter
An
accredited QMS certification process must
ensure the following:
An
organizations QMS must meet the requirements
of the relevant standard.
The QMS analyzes and understands customer
requirements and is aware of relevant statutory and
regulatory requirements.
Product characteristics have been defined.
Outcomes Matter
An
accredited QMS certification process must ensure the
following:
The
QMS has identified and manages the processes
needed to achieve the expected outcomes.
The QMS aims to prevent nonconformities and has processes
in place to correct nonconformities, analyze root cause and
take corrective action. (Focus of PJRs Root Cause and
Systemic Corrective Action Seminars).
The organization is monitoring, measuring and
continually improving the effectiveness of its QMS.
Outcomes Matter
An
accredited EMS certification process must
ensure the following:
The
organization is managing its environmental
impacts.
The organization is demonstrating commitment to
preventing pollution, meeting legal requirements and
continually improving environmental
performance.
Outcomes Matter
Todays
seminar focuses on helping your organization
accomplish the following:
The
QMS has identified and manages the processes
needed to achieve the expected outcomes.
The organization is monitoring, measuring and
continually improving the effectiveness of its QMS.
The organization is continually improving its
environmental performance.
The Basics
Process Mapping Terminology
Terminology
Process
a sequence of steps, activities,
decisions or tasks that transforms inputs into
outputs.
We
talk about adding value. This is when the
outputs of a process are of greater value than the
inputs.
Inputs
Customer who has a
need
Process
Add Value?
Outputs
Customer who has
a need met
Terminology
Process
Boundaries designated start and end
points of a process.
Should
be logical
Must be determined before a process can be
described.
Usually defined as a customer with a need and a
need being met.
Terminology
Process
Inputs any product or service used in the
process
People
Equipment
Material
Documentation
Environment
Suppliers
Internal
provide the needed inputs for a process
Suppliers
External Suppliers
Terminology
Outputs
a product or service created by the process
that is of value to the customer.
Evidence
that work has been completed.
Must be specific
Output of one process is often the input of another.
Customers
individuals who benefit from the products or
services produced by the process
Internal
customers
External customers
Terminology
Customer requirements
needs, wants or
expectations that internal or external customers
have for the output of the process
May
be written or unwritten
Process
owners an individual(s) who is/are
accountable for the process.
Determined
by the process boundaries
May be a team of people
Terminology
Process
Approach the application of a system
of processes within an organization, together with
the identification and interactions of these
processes, and their management.
Processes
should be automatic and instinctive to
all personnel.
The Basics
Process Mapping Symbols
Process Mapping Symbols
Rectangles
used to identify a discrete activity in
the process. Content of rectangle is usually a
verb and direct object.
Lines with Arrowheads Represent the direction
and flow of the activities in a process.
Visually inspect
parts
Place green
label on
conforming parts
Pack parts
Process Mapping Symbols
Start
and end ovals used to signify the starting
point and end point of a process, the
boundaries.
Start
End
Process Mapping Symbols
Decision Diamonds represent a decision in
a process, a question that must be answered
with a yes or no.
Have
one line entering and two lines leaving (yes
and no) Is the part YES Pack in plastic
conforming?
NO
Label with red tag and
place in
nonconforming bin
bin
Process Mapping Symbols
Loop
displays a part of the process that repeats
itself until a specific condition is met.
Often
takes the process back to other steps.
Indicate areas where activities such as rework are
needed.
Inspect part and
remove excess
flash
Is part
free from
flash?
NO
YES
Place green label
on part and
pack in plastic bin
Process Mapping Symbols
Circles
used to reference or connect another
part of the process when the process continues
to another page.
B
Process Mapping Symbols
Parallel
process process or process steps that
occur at the same time as another process.
The Basics
Different Ways to Visualize a Process
Benefits of Making a Process
Visible
Process
Improvement
Allows
relationships and sequences to be identified and
analyzed
Serves as an aid to problem solving
Education
and Training
Way
to train employees on changed processes
Assist in training new employees
Documentation
Clarifies
the flow of work in a process
Eliminates the need for lengthy procedures and work
instructions in narrative format
Flow of Work in a Single Process
Block
Diagrams
Process Maps
VISIO
Microsoft
Block Diagram
Simple
Uses
schematic of the major steps of a process
rectangles or blocks and arrows
Answers the question: What is the process?
Process Map
Detailed schematic of the steps, activities
or tasks
that shows how something is done
Shows
decision points and feedback loops
Answers the question: What is the process and how
does it work?
Sequence and Interaction of
Processes
Shows
the interrelationship of all of an
organizations processes
This
is different that block diagrams and process
maps of single processes.
Dont forget outsourced processes!
Requirement of ISO 9001:2008
14001:2004
and ISO
Sequence and Interaction of
Processes
Relevant ISO
The
9001:2008 clauses
organization shall identify the processes
needed for the quality management system and
their application throughout the organization,
[4.1a]
determine the sequence and interaction of these
processes, [4.1b]
Sequence and Interaction of
Processes
Relevant ISO
The
9001:2008 clauses
organization shall establish and maintain a
quality manual that includes a description of the
interaction between the processes of the quality
management system. [4.2.2c]
Sequence and Interaction of
Processes
Relevant ISO
The
14001:2004 clause
environmental management system
documentation shall include a description of the main
elements of the environmental management system
and their interaction [4.4.4c]
Wake Up!
This is the Most Important Slide
Before
we can talk about a sequence and interaction of
all processes of an organization, we must first:
Determine
This
the processes of an organization (STEP 1)
is a critical but often not performed step.
Many organizations simply construct a block diagram or process map
of their main (manufacturing) process This is not sufficient and
does not meet the intent of ISO 9001:2008.
Required by clause 4.1a of ISO 9001:2008 and clause 4.4.4c of ISO
14001:2004.
Stay Up!
This Slide is Just as Important
Bring staff together from
various
departments/functions and brainstorm the
processes of your organization. (Step 1)
For this exercise, put ISO 9001:2008 and ISO
14001:2004 away. Better yet forget they exist!
Processes
shouldnt be named after headings or subheadings of the standard.
Processes should be unique to your organization and
match the language your employees speak.
Stay Awake!
Once
you determine the processes of your organization,
focus on each process individually (Step 2):
Determine
the boundaries of each individual process
Generate a list of steps of the process
Should
be broken down until further breakdown no longer contributes
additional value.
Write each step on an index card or sticky note
Sequence
Easy
the steps
to move index cards or sticky notes
Required by clause 4.1b of ISO 9001:2008
Remember the Theme
Remember
the theme of todays presentation Outputs
Matter!
The
organization is monitoring, measuring and
continually improving the effectiveness of its QMS.
For
each process, the organization must identify a
measure of process performance and an associated
target. (Part of Step 2)
Key
performance indicator (KPI)
Required by clause 4.1e of ISO 9001:2008 and clause 4.3.3 of
ISO 14001:2004.
Remember the Theme
Inappropriate
Improve
measures of processes
customer satisfaction
Strive to continually improve all processes
Improve delivery performance
Reduce employee turnover
Lower PPM
Remember the Theme
There
should be a measure of process effectiveness for
each identified process of the organization.
Some appropriate examples include:
Maintain
a close ratio of at least 30% for all quotations
Scrap rate of <2%
Manufacturing process efficiency of >95%
Receive corrective action plans for all internal audit
nonconformities within 30 days
Completion of all planned internal audits
Measurables
may be variable or attribute in nature.
Remember the Theme
What
happens when a target isnt met?
Corrective
action is required per clause 8.2.3 of ISO
9001:2008:
The
organization shall apply suitable methods for monitoring and,
where applicable, measurement of the quality management system
processes... When planned results are not achieved, correction and
corrective action shall be taken, as appropriate, to ensure conformity
of the product.
Consider
also clause 8.4c of ISO 9001:2008:
The
organization shall determine, collect and analyze appropriate
data to demonstrate the suitability and effectiveness of the quality
management system The analysis of data shall provide information
relating to characteristics and trends of processes and products
including opportunities for preventive action
Are
we trending in the right direction?
Stay Awake!
Earlier
we learned that the output of one process
is the input of another.
Watch
for these linkages as you construct process
maps for individual processes.
These
linkages will help you determine the
sequence and interaction of all processes of your
organization (Step 3).
Bakeries
A Practical Example
Bakeries Block Diagram for a
Single Process
Following
is an example of a block diagram or process
map for a bakery specializing in wedding cakes.
Input:
Receive specification sheet and order for a wedding
cake.
Output: Wedding cake ready for delivery.
Appropriate
measures of effectiveness (KPI) for the
process of baking and decorating a wedding cake are
also included.
Repeat this exercise for all processes in your
organization.
Bakeries Sequence and
Interaction of Process
Following is
an example of a sequence and
interaction of processes for an entire
organization, our bakery.
Note this is different than a block diagram or
process map of a single process.
Process Approach to Auditing
Process Approach to Auditing
Different than
Checklists
a checklist audit
turn the requirements of the standard into
questions.
Checklist questions never change or grow with the
process.
Internal
audits should be one driver of process
improvement
A
process approach to internal audits does just that.
Process Approach to Auditing
Need
to get away from the idea that an internal
audit should confirm your management system
addresses all the shalls or requirements of a
standard.
Importance
of a tool such as PJR Form F-191 or
equivalent documents
Process Approach to Auditing
Once you know your management system
processes address all the requirements of the
standard, then you can audit processes as your
organization has defined them.
Keep
in mind the requirements of section 4.1 of ISO
9001:2008 as you audit the processes of your
organization.
ISO 9001:2008, section 4.1
The
organization shall identify the processes needed for the quality
management system and their application throughout the organization,
[4.1a]
determine the sequence and interaction of these processes, [4.1b]
determine criteria and methods needed to ensure that both the
operation and control of these processes are effective, [4.1c]
ensure the availability of resources and information necessary to
support the operation and monitoring of these processes, [4.1d]
monitor, measure and analyze these processes, and [4.1e]
implement actions necessary to achieve planned results and continual
improvement of these processes. [4.1f]
Process Approach to Auditing
Development
of an audit working document that focuses
on:
Process
inputs
Process outputs
Competencies required for the process
Requirements for the process (procedures, work instructions,
customer drawings)
Equipment and other resources
Measures of process effectiveness
Process Approach to Auditing
Interview the
process owner using the audit
working document as a tool.
Confirm interview results through observation of
the process, review of process documents and
records and interviews with personnel actually
performing the process.
Process Approach to Auditing
Always
ask: How do you know the process is
working/improving?
Link
to process measurable (KPI)
Remember Outcomes Matter!
Always
ask: What do you do/how do you react
when the process does not meet the defined
target?
Other Techniques for Effective
Internal Audits
Remember
the guidance provided in the Root
Cause/Systemic Corrective Action Seminar about
how to properly document an audit finding:
Statement
of Finding
Objective Evidence
Citation of requirement not being fulfilled
Other Techniques for Effective
Internal Audits
Other techniques
Set
are listed in PJR Advisory #31
yourself up for success Audit plan should reflect
the names of the processes of your organization not
sections/clauses of the relevant standard.
Outputs Matter! Make sure your audit criteria are
complete. Integrate customer-specific and other
requirements within your process-based internal
audit.
Other Techniques for Effective
Internal Audits
Other Techniques
Internal
are listed in PJR Advisory #31
Auditor Competency There is no
requirement for a training course. There is a need for
an organization to establish competency
requirements for its internal auditors. There must be
objective evidence internal auditors meet these
competency requirements.
Internal auditor independence
Thank you!
Questions or Comments?
Shannon Craddock
(800) 800-7910
scraddock@pjr.com
