Volume 2, Issue 1
Special points of interest:
• ASR now offers public training
• ANSI/AIHA Z10 Released
• Process Approach to Auditing & Expectations
• ASR Provides New Service
New Food Safety Management System Offers
Opportunities to Global Food Supply Chain
ASR’s Partnership Paper
By Bill Grande, Food Think (www.FoodThink.com)
As global markets for food and
food products continue to grow
the need for harmonization of
international food safety standards is becoming an essential
component for facilitating effective and efficient trade agreements and protocols between
trade partners and regulatory
bodies alike.
After years of development, the
International Organization for
Standardization (ISO) issued its
new food safety management
system standard, ISO
22000:2005 last October. This
new standard, first in the 22000
family, applies to any participating organization within the
food industry; basically from
farm inputs through final food
product preparation, packaging
and delivery to the ultimate
user.
This new international standard
provides a framework for any
food supply chain participant to
demonstrate compliance with
applicable statutory and regulatory food safety requirements
across all food product realization activities, locations, and
phases. By complying with this
standard, an organization demonstrates that its food safety
management system meets the
requirements established by
applicable regulatory bodies, as
well as suppliers, customers,
and other participants, while
guarding against contamination
that may enter food and food
products at any link in the food
chain.
ISO 22000:2005 at a glance
The new food safety management system leverages existing
food safety programs – ISO
ASR to Provide Additional Service
American Systems Registrar has
been invited to participate in the
Control System Integrators Association (CSIA) certificated member
program. This means that ASR
will provide registration audits to
the association’s best practices
specification.
A Control System Integrator is an
Engineering firm that focuses on
industrial control and information
systems, manufacturing execution
systems and plant automation.
Integrators assist organizations
with enhancing or developing the
above systems.
ASR can assist the CSIA member
base in achieving and maintaining
Certified Member status with thor-
9001:2000 and HACCP – to
compliment either of these programs individually, or combine
them into a “stand alone” program. Organizations that currently have ISO 9001:2000 and/
or HACCP certifications are in
good position to adapt/adopt
ISO 22000:2005 components
and thereby provide additional
assurance of food safety compliance to applicable regulatory
bodies, their customers, and ultimately consumers of their food
products.
_________________________
ISO 22000:2005 consists of three
sets of interdependent components (requirements):
1. Pre-requisite programs e.g.
good manufacturing practices
2. HACCP principles
3. Management system
——————————–——
See Food Safety Management on pg. 2
ough, independent auditing that
contributes to the improvement of
business and customer satisfaction.
The CSIA association is in its second decade of helping system integrators become better business people. CSIA’s trademarked Certified
Member Program provides an industry-specific means for end users
to identify areas of importance and
minimize uncertainties in selecting a
system integrator. This program also
offers a framework for integrators to
evaluate and continuously improve
their own businesses.
Inside this issue:
Food Safety Management
1-2
ASR to Provide
Additional Service
1
Process Approach to Auditing
2-5
ANSI/AIHA Z10
5
The Process Approach and Surveil- 5
lance Audit Requirements
ASR Training
6
Page 2
A S R ’ S P AR T N E R S H I P P AP E R
Food Safety Management Continued
The major tenets of ISO 22000:2005
address:
ο Interactive communication and
documentation requirements
ο System management i.e. management responsibilities and resource management
ο Planning and realization of safe food
products
ο Validation, verification and im-
provement of the food safety management system
Opportunities offered by ISO
22000:2005
By adapting/adopting ISO 22000:2005
any organization can realize business
success in three dimensions:
1. internal, namely measurable improvement in operational efficiencies
2. internal and external represented by
global recognition of their food
safety management system and reducing or potentially eliminating the
need for multiple systems
3. external, namely measurable improvement in customer satisfaction
reflected by sustained profitability
and continued market growth opportunities
ISO 22000 family includes: (1) ISO/TS22004, Food safety management systems – Guidance on the application of ISO 22000:2005;
(2) ISO/CD TS 22003, Food safety management systems – Requirements for bodies providing audit and certification of food
safety management systems; and (3) ISO/DIS 22005, Traceability
in the feed and food chain – General principles and guidance for
system design and development.
To obtain a copy, contact ANSI at webstore@ansi.org
Process Approach to Auditing and Expectations of Our Customers
By Bart Solomon, ASR Technical Expert
I am often asked the question “Do I
have to do process auditing?” ASR has
had many discussions concerning this
topic. So I would like to analyze the
requirements and try to reach a logical
conclusion that adds value to your quality management system and sets out
ASR’s expectations for your internal
audit program.
Let’s start by looking at what ISO
9001:2000 requires:
“The organization shall conduct internal audits at planned intervals to determine whether the quality management
system
a) conforms to the planned arrange-
ments, to the requirements of this International Standard and to the quality
management system requirements established by the organization, and
b) is effectively implemented and
maintained.
An audit program shall be planned,
taking into consideration the status and
importance of the processes and areas
to be audited, as well as the results of
previous audits.”
So at least clause 8.2.2 does not explicitly require process auditing. However,
this clause does require that we audit
“whether the QMS conforms to
planned arrangements”. Many of these
planned arrangements are concerned
with the management of the processes and the links between the processes as outlined in clauses 4.1 (a – f)
and 8.2.3.
In order to audit whether the system
conforms to planned arrangements
and whether the QMS is effectively
maintained, we need to audit the
management of the processes and the
effectiveness of the processes.
Let’s start by looking at the management of processes.
See Process Approach on pg. 3
VOLUME 2, ISSUE 1
Page 3
Process Approach Continued
Audit Turtle Diagram
Step 2
Step 1
What resources are
needed for the process?
Who participates
in the process?
Step 3
Step 4
Step 5
Inputs
Process
Activities
Outputs
Step 7
Step 6
Are there monitors
and measures that show effectiveness?
How is the process implemented and controlled?
Managing Processes
A process can be described in several
ways; procedures, work instructions and
flowcharts. Many organizations have
found turtle diagrams to be a very effective way to describe the management of
their processes (see figure above).
All processes have inputs, a set of activities to produce the outputs of the
process, shown in Steps 3-5 of the
turtle diagram. The inputs and outputs
can include both tangible raw materials
and components and intangible information. The management of the process is shown in the boxes at the corners
of the turtle:
Step 1 - Manpower/training/
competence - for each process the
manpower requirements including
the necessary training, competence
and evaluation of competence
should be defined; and a process
owner should be identified so that
someone has clear responsibility for
the process.
Step 2 - Infrastructure (machines,
facilities) - the machines and facilities necessary for the process should
be defined and managed, that is
maintained and improved as
needed; this also includes any software necessary for the process.
Step 6 - Control Methods - methods
for controlling the process include:
Documentation -each process should
have some minimal documentation,
more important or difficult processes may require additional documentation. The documentation
could include process flowcharts,
procedures, work instructions and
forms
Set-up approval – some processes are
controlled by approving the set-up
of the process to established operating conditions
Monitoring/inspection – some processes have instrumentation that
monitors the process, others are
monitored by in-process or product
inspection activities
Action if the process drifts - the control should include actions if the
process deviates from what is
planned – these tend to be short
term actions which the Standard
refers to as corrections (in clause
8.2.3)
Step 7 - Metrics and reporting - the
process should be monitored for its
effectiveness and actions taken if
the effectiveness is not adequate.
This monitoring may be based on
the control data collected in Step 6
which is evaluated over a longer
period of time and used to determine if corrective or preventive
action should be taken on the process to improve the process. These
actions are not the process adjustments (corrections) in Step 6 but
are actions taken to change the way
the process is performed or controlled.
Some organizations supplement the
turtle diagram with a process flowchart
since the turtle does not show the sequence of steps that make up the process.
This management of the processes
should provide the basis for our internal audit program.
Let’s start with the planning of the
audit program.
Audit program planning
The audit program should be planned
and scheduled around the actual processes that make up the quality management system. We start with the processes that make up our quality management system and the interactions of
these processes among each other.
This information can come from your
process map.
The first step is to list the processes on
the matrix below; we have found this
matrix to be helpful in identifying
which ISO 9001 requirements apply to
which process. The second part of the
audit program planning is to define the
audit schedule. The important points
to consider in defining the schedule
are to make sure that
• Entire quality management system is
audited
• Important processes are audited
more frequently that less important
processes
See Process Approach on pg. 4
Page 4
A S R ’ S P AR T N E R S H I P P AP E R
Process Approach Continued
Process
4.1
4.2
5.1
5.2
5.3
5.4
5.5
5.6
6.1
Management
Review/CI
X
X
X
X
X
X
X
X
X
6.2
6.3
6.4
7.1
7.3
7.4
7.5
7.6
8.1
8.2
8.3
X
Internal Audit
Corrective
action/preventive
action
Quote
Order review &
entry
Scheduling
Production
Shipping
Purchasing
QA-inspection &
test
Calibration
Facilities &
maintenance
Training &
competence
Document
control
Records control
7.2
8.4
8.5
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
• Processes with key linkages are audited by the same audit team
• Processes with key linkages are audited back-to-back so that the linkages can be audited
The decisions concerning the importance of the processes and the process
linkages can be discussed with top
management to make sure their priorities are represented in the internal audit program.
Next let’s discuss the auditing of the
processes.
Auditing processes
Do your auditors use the same checklist each audit?
Is the checklist based on the clause
requirements in ISO 9001:2000?
Do your auditors ask the same questions and look at the same things every
time they audit?
If your answers are yes, then consider
refocusing the auditors on the process
and most importantly on the performance of the process.
The turtle diagram can help. We have
found the turtle diagram a useful tool
for auditing a process.
The auditor starts with Step 1 and interviews the process owner to obtain a
description of the process and discuss
the resources necessary (Step 2). Then
various participants in the process are
interviewed to audit the inputs, activities
and outputs of the process (Steps 3, 4
and 5). The control of the process (Step
6) is also audited with the process participants and the process owner. During these interviews the auditor should
focus on the data from the process and
explore any instances when the data
does not appear to meet the needs of
the next process in-line or the needs of
the customer.
See Process Approach on pg. 5
Audit Turtle Diagram
Step 2
Step 1
What resources are needed
for the process?
Who participates
in the process?
Step 3
Step 4
Step 5
Inputs
Process
Activities
Outputs
A TURTLE
DIAGRAM
Step 7
Step 6
CAN HELP!
Are there monitors
and measures that show effectiveness?
How is the process implemented and controlled?
VOLUME 2, ISSUE 1
Page 5
Process Approach Continued
Finally the performance of the process is reviewed with the process owner. Questions such as,
• Have objectives for the process been established? What performance is expected?
• How is the process performing at achieving those objectives? Review the data.
• Are actions being taken to assure that the process achieves objectives?
• What improvements to the process are necessary?
• How are these improvements being implemented?
The focus on the data from the process will assure that the questions vary from audit to audit, since the data will change.
This will focus the auditor on the actual performance which will drive improvement of the process and the organization.
Conclusion
Refocusing the audit program and the auditors on the process(es) and the information/data coming from the process will
rejuvenate the audit program and focus the internal audit program on improved performance.
ANSI/AIHA Z10 Released
ANSI/AIHA Z10, a co-sponsored standard from ANSI and the American Industrial Hygiene
Association, has officially been released. This standard mirrors the Occupational Health and
Safety (OHSAS) 18001 Standard that has been in existence since 1999. Many companies are already familiar with and registered to OHSAS 18001.
Currently, there has been limited interest in the United States for the ANSI/AIHA Z10 version of
Occupational Health and Safety as companies appear to be satisfied with the OHSAS 18001 and
see little value in switching to the Z10 document.
ASR will continue to monitor this standard and market, and keep you updated.
ISO 9001:2000, The Process Approach & Surveillance Audit Requirements
By Brad Bukowski, ASR Registration Manager
We all know that at a Registration
and/or a Re-Assessment Audit, auditors are required to review all elements
of a Quality Management System as
defined by the customer’s processes
and the ISO 9001:2000 Standard, but
what truly needs to be audited during a
surveillance audit? There is obviously
less time involved, so a comprehensive
look at the whole system is not possible. However, as a Registrar, we want
to give you a value-added audit that
assists you with improving your business!
So, what really has to be audited at
each surveillance?
The following areas MUST BE covered
Annually:
∗ Management Review (5.6, 8.2.1,
8.2.3, 8.4, 8.5.1)
∗ Improvement Process (8.5.1, 8.2.3)
∗ Internal Audit (8.2.2, 8.2.3)
∗ Corrective Action (8.5.2, 8.2.3)
∗ Preventive Action (8.5.3, 8.2.3)
If a company is on an annual surveillance schedule of 1.0 audit day, half the
time could be spent auditing the above
items. Remaining time would be spent
reviewing other areas of the system.
Areas could include Manufacturing or
Service Processes, Design & Development, Non-Conforming Product, Measurement & Analysis, Purchasing and so
forth.
ASR’s goal is to provide the customer
with a comprehensive audit whether it
is a Registration, Re-Assessment or
Surveillance Audit. We will do that by
auditing those items that are required
and then reviewing those parts of your
system where we can truly add value
and assist you with improvement of
your business!
ASR Public Training
ASR is now offering Public Training Courses as an additional service to our customers.
Our first course (ISO 9001:2000 Internal Auditing) on May 2-3,
2006 was a success. Auditing for Business Improvement is scheduled for September 12, 2006.
Please contact us if you would like more information or would like
to attend. Additional courses may be added in the fall or in early
2007. We will keep you posted!
American Systems Registrar
Corporate Office
5989 Tahoe Drive
Suite 120
Grand Rapids, MI 49546
Phone: 888-891-9002
Fax: 616-942-6409
Email: info@ASRworldwide.com
ASR NOW
OFFERS PUBLIC
TRAINING!