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January, 2005
Welcome to the Whittington & Associates e-Newsletter!
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January
Articles
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Atlanta Classes |
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Click on a title to jump to the
article:
1.
Preparing your Organization for an Audit
2.
New ISO 9001:2000 Interpretations
3.
Auditing Statutory and Regulatory Requirements
4. Online
Source for Workplace Safety Regulations
5.
New RABQSA and ANAB Web Sites
6.
Classes: January, 2005 - March, 2005
Call us at 1-800-404-7585 for these 1-day onsite classes:
- AS9100B:
Requirements Beyond ISO 9001:2000
- ISO 9001:2000 Auditor
Update - The
Process
Approach
- Understanding
ISO/TS
16949:2002
Requirements
To
see previous
articles, go to Newsletter
Archives.
To avoid this
newsletter
being rejected, or placed in a junk folder, please add <Larry@WhittingtonAssociates.com>
to your address
book or accepted list.
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Students attending
a class in Atlanta receive a 20% discount on future Atlanta classes.
ISO
9001:2000 Lead Auditor
February 14-18, 2005
ISO
9001:2000 Internal Auditor
January 25-27, 2005
Understanding ISO 9001:2000 Requirements
February 7, 2005
Quality System Documentation
February 8-9, 2005
Implementing ISO 9001:2000
February 10-11, 2005
Green
Belt Certification
January 31 -
February
2, 2005
Black
Belt Certification
Group 14 (3 weeks): February
21-25
+ March 21-25 + April 18-22
Training
Classes in
Other Cities
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1. Preparing your Organization for an Audit
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To
prepare an organization for an audit, managers should:
- Become familiar with the documents for their
area
- Walk through the area for a spot check on
operations
- Verify that only valid documents are in use
- Ensure the work areas are clean and orderly
- Confirm that past nonconformities have been
fixed
- Brief employees on how to interact with
auditors
- Communicate a positive, learning view of the
audit
For external audits requiring an
escort, your guides
should:
- Know the quality system and how it operates
- Understand the audit plan and functional
areas
- Be available by staying with the audit team
- Clarify, not answer for the persons
interviewed
- Act as witnesses for any audit findings
- Help keep the auditors on the planned
schedule
- Take good notes for possible follow-up
actions
Of course, employees in the areas to be audited should:
- Understand
the quality policy and their role
- Prepare by participating in internal audits
- Know where their documents are located
- Be able to quickly retrieve their records
- Know how to respond to auditor questions
- Be prepared to demonstrate their activities
- Understand the quality objectives for their
area
Employees should remember to:
- Provide brief, honest answers to questions
- Answer specific questions; don’t volunteer
- Be cooperative, not misleading or defensive
- Ask for clarification if they don’t
understand
- Refer auditor to the right person for answer
And, be prepared to answer audit
questions such as:
- What is the overall purpose of this process?
- Please describe your job and
responsibilities.
- What are the process inputs and who supplies
them?
- What resources are needed for this process?
- What are the process outputs and who
receives
them?
- How do you know what to do?
- What training, skill, and
experience are needed?
- Show me, or tell me, how you do
it
- How do you know if it is done
right?
- When it is not right, what do
you do?
- What records are kept of this
activity?
- How is the process controlled?
- What are the process
objectives?
- How is the performance
measured?
- How could this process be
improved?
2. New ISO
9001:2000 Interpretations
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ISO Technical Committee 176 established
a web site for ISO 9001:2000 interpretations at <http://www.tc176.org/Interpre.asp>.
Their earlier interpretations were included in our January 2004 and
September 2004
newsletters. Since those newsletters, the committee has added these ISO
9001:2000 interpretations:
ISO 9001:2000 Interpretation RFI – 043
Request: ISO 9001:2000 Clause 7.3
Does ISO 9001:2000 require Clause 7.3 to be
applied
to the design and development of the package necessary to preserve the
conformity of the product during delivery?
Background: This
request for interpretation does not address the
packaging process, but the package that is necessary to protect the
product.
Interpretation: Yes.
Rationale: The organization is, per
sub-clause 7.5.5, responsible for preserving the conformity of the
product. Preservation includes packaging. In cases where design and
development of the package is necessary to preserve conformity, this
has to be performed in accordance with Clause 7.3 of the standard.
ISO 9001:2000 Interpretation RFI – 046
Request: ISO 9001:2000 Clause
7.4.1
Does Clause 7.4.1 require that records of evaluations of suppliers and
any necessary actions arising from these evaluations be maintained by
all organizations, irrespective of their size?
Background: In small companies where the owners are personally
responsible for the purchasing of resources and know their individual
suppliers, maintaining records of supplier assessments can be very
bureaucratic.
Interpretation: Yes.
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3. Auditing
Statutory and Regulatory Requirements
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This article is based on an auditing
guidance paperavailable at <http://isotc176sc2.elysium-ltd.net/APG_index.html>.
Also, see our earlier article, Internal Audits of Regulatory Requirements, in our March 2004 newsletter at: <http://www.whittingtonassociates.com/v2/newsletter/back_issues/e2004_03.shtml#article3>.
ISO 9001:2000 requires an organization to identify
and control the
statutory and regulatory requirements applicable to its products
(including
services). It is up to the organization how to do this within its
quality management system. The organization should demonstrate that the
legal requirements applicable to its products / services have
been
properly identified, are available, and easily retrievable.
Auditors
need to be aware of the statutory and regulatory requirements
applicable to the
products/ services included
within the scope of the system. During
the audit preparation phase, the audit team should obtain relevant
information from internal or external sources with
respect to these legal requirements. This
will allow the auditors to make a judgment on the suitability of the
system to
address
such requirements. These requirements need to be identified and
integrated in
the resource management and product realization activities of the
organization.
During the
audit phase, the audit team should:
- ensure that the organization
has a methodology in place for identifying, maintaining, and updating
all
applicable statutory and regulatory requirements
- ensure that these statutory
and regulatory requirements are utilized as ‘process inputs’ while
monitoring
‘process outputs’ for compliance with requirements
- ensure that any claimed
compliance to standards, statutory, and regulatory requirements, etc.
are
properly demonstrated by the organization
If evidence is found
during the audit that
specific information regarding legal requirements has not been taken
into account, the auditors
should
issue a nonconformity. The auditors should
also
issue a nonconformity if a noncompliance with such requirements is
directly
identified.
Auditors should avoid making statements about what
statutory or
regulatory requirements are applicable to the products and services of
the
organization, or about methods of compliance, because of possible
liability.
Nonconformities
should be issued only in situations where identification has been made
of
system deficiencies or of direct violations in respect of statutory and
regulatory requirements applying to the products / services of the
organization.
However,
if a noncompliance with other kinds of statutory requirements (e.g.,
health and
safety, environment, etc.) is, co-incidentally, detected during the
audit, this
fact cannot be ignored by the audit team. It should be reported
without delay to the auditee and, if required, to the audit client.
Note: The ISO 9001 Auditing Practices Group
is an informal group of quality
management system (QMS) experts, auditors, and practitioners drawn from
ISO Technical Committee 176 and the International Accreditation Forum.
It has developed a number of guidance papers and presentations that
contain ideas, examples, and explanations about auditing. These
documents reflect the process-based approach that is essential for
auditing the requirements of ISO 9001:2000.
The guidance is primarily aimed at QMS
auditors, consultants, and quality practitioners, but is not
definitive. The papers and presentations reflect a number of different
views in QMS auditing. As such, their content may not always be
consistent. It is not intended for the guidance to be used as specified
requirements, an industry benchmark, or as criteria that all QMS
auditors, consultants, or practitioners have to follow.
The guidance documents are available at: <http://isotc176sc2.elysium-ltd.net/APG_index.html> and cover these
individual topics:
- The need for a 2-stage approach
to auditing
- Measuring QMS effectiveness and
improvements
- Identification of processes
- Understanding the process
approach
- Determination of the “where
appropriate” processes
- Auditing the “where
appropriate” requirements
- Demonstrating conformity to the
standard
- Linking an audit of a
particular
task, activity or process to the overall system
- Auditing continual improvement
- Auditing a QMS which has
minimum
documentation
- How to audit top management
processes
- The role and value of the audit
checklist
- Scope of ISO 9001:2000, Scope
of
quality management system and defining scope of certification
- Value-added auditing
- Auditing competence and the
effectiveness of actions taken
- Auditing statutory
and regulatory requirements
- Auditing
the quality policy and quality objectives
- Auditing ISO 9001, Clause
7.6, Control of monitoring and measuring devices
- Making
effective use of ISO 19011
- Auditing
customer feedback processes
All the documents are short 2
to
8 page Word documents, with the exception of one PowerPoint file
consisting of 33 slides.
Feedback from users will be used by the ISO
9001 Auditing
Practices
Group to determine whether additional guidance documents should be
developed, or if these current ones should be revised. Comments on the
guidance can be sent to: <charles.corrie@bsi-global.com>.
4. Online Source for Workplace Safety Regulations
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If you want a quick resource for tracking government regulations, as
well as, the
materials and information to stay compliant, go to: <http://www.complianceregs.com.
Here, in one place, you will find virtually all the safety
data you need, including:
- Current regulations from the U.S. Code
of Federal Regulations, including the full text of the OSHA,
Construction, EPA, and DOT regulations
- Notices, proposed
rules, and
other documents from the Daily Federal Register
- A searchable MSDS
database containing more
than 350,000 Material Safety Data Sheets
- Links to the state
plans of the 17 states
that
operate their own safety and health
programs
- Downloadable compliance
forms, e.g., OSHA confined space permits and EPA waste forms
- Safety checklists you
can use to
monitor
compliance
- A complete list of
state and federal OSHA
offices with full contact information
- A link to OSHA's
QuickTakes newsletter, the
biweekly bulletin on the agency's latest
activities
This web site is made
available by Compliance
Magazine.
5. New RABQSA and ANAB Web Sites
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The RAB
will cease operation on January 1, 2005 and be replaced by RABQSA
International. The ANSI-RAB National Accreditation Board will become
the ANSI-ASQ National Accreditation Board (ANAB).
New web sites are under construction at: http://www.rabqsa.com
and
http://www.anab.org
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6. Class Schedule: January, 2005 - March, 2005
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To enroll
in these
public classes, go to Class
Schedule at our web site, or call us at 800-404-7585. Classes
taught by Larry Whittington are shown in yellow.
ISO
9001:2000 Lead
Auditor (RAB Accredited) - BSI Management Systems
Initial
course version developed by Larry Whittington
| January |
February |
March |
| 10-14 Reston, VA |
7-11 Charlotte, NC
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7-11 St.
Louis, MO |
| 24-28 San
Diego, CA |
14-18 Atlanta, GA
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14-18 Las
Vegas, NV |
| 31-04 Houston, TX |
14-18 Orlando, FL
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21-25 Reston, VA |
| - - |
28-4 San Jose, CA
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- - |
ISO
9001:2000
Internal Auditor (RAB Accredited) - BSI
Management Systems
| January |
February |
March |
| 19-21 San
Diego, CA |
8-10 Reston, VA
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15-17 San
Jose, CA |
| 25-27 Atlanta, GA |
- -
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22-24 Chicago, IL |
- -
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- -
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29-31 Atlanta, GA |
Implementing
ISO
9001:2000
Course
developed by Larry Whittington
| February |
May |
| 10-11 Atlanta, GA |
3-4 Reston,
VA |
| 24-25 Reston, VA |
19-20 Atlanta, GA |
Understanding
ISO
9001:2000
| February |
May |
| 23 Reston, VA |
2 Reston, VA |
Understanding
ISO
9001:2000 Requirements (Atlanta Only - $295)
Course
developed by Larry
Whittington
| February |
May |
| 7 Atlanta, GA |
16 Atlanta, GA |
Quality
System
Documentation (ISO 9001:2000)
Course
developed by Larry
Whittington
| February |
May |
| 1-2 Reston,
VA |
5-6 Reston, VA |
| 8-9 Atlanta, GA |
17-18 Atlanta, GA |
The above
public
courses can
be offered on-site at your facility. In addition, we offer these
on-site courses:
- ISO 9001:2000
Auditor Update - The
Process
Approach (1 Day) - Course developed by Larry
Whittington
- Understanding
ISO/TS 16949:2002
Requirements (1 Day) - Course developed by Larry
Whittington
- Internal
Quality
Auditing (2 Days) - Course developed by Larry
Whittington (based on ISO 19011)
- AS9100B:
Requirements Beyond ISO 9001:2000 (1 Day) - Course developed by Larry
Whittington
To arrange
an
economical
on-site class, please call us at 800-404-7585.
© 2000-2004 Whittington & Associates, LLC. All
rights reserved.
You may copy this e-Newsletter provided you copy it completely, do not change
it, and include this copyright notice.
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