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Greetings! Welcome to the Whittington & Associates
e-Newsletter!
Visit and bookmark our web
site.
Our newsletters provide guidance on ISO 9001,
AS9100, ISO 13485, ISO/TS 16949, TL 9000, ISO
14001,
ISO 27001, ISO 20000, ISO 22000, and related ISO
standards, as well as, Six Sigma.
If you have any questions about the articles
appearing in this issue, or you want to suggest
topics for future issues, please let us
know.
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Risk Management for Medical Devices |
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The second edition of ISO 14971:2007,
Application of Risk Management to Medical
Devices, has been released. The revised
version aligns better with ISO 13485:2003
requirements and provides an improved model
for implementing a risk management system.
ISO 14971:2007 specifies a process for a
manufacturer to identify the hazards
associated with medical devices, including in
vitro diagnostic (IVD) medical devices, to
estimate and evaluate the associated risks,
to control these risks, and to monitor the
effectiveness of the controls. The
requirements of ISO 14971:2007 are applicable
to all stages of the life-cycle of a medical
device.
You can purchase the standard for $160 at
this web
page at the ANSI site.
ISO/TR 14969:2004 provides guidance for
applying the requirements for quality
management systems contained in ISO 13485. It
does not add to, or otherwise change, the
requirements of ISO 13485. It does not
include requirements to be used as the basis
of regulatory inspection or certification
assessment activities. However, its guidance
can be used to better understand the ISO
13485 requirements and to illustrate some of
the methods and approaches available for
meeting those requirements.
We offer the following ISO 13485 courses:
Understanding
ISO 13485
ISO
13485 Internal Auditor
Implementing
ISO 13485
ISO
9001 Lead Auditor (with Emphasis on ISO
13485)
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FMEA Quality Tool |
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Have you heard about FMEA, but remain unsure
of its use as a quality tool? Well, FMEA is
the acronym for Failure Modes and Effects
Analysis.
Failure Modes are the ways in which something
might fail. The failures are actual or
potential errors or defects, especially those
affecting the customer.
Effects Analysis refers to studying the
consequences or effects of those failures.
Failures are prioritized according to the
seriousness of their consequences, the
frequency of their occurrence, and likelihood
of their detection. The purpose of FMEA
is to take actions to eliminate or reduce
failures, starting with the higher priority
ones.
FMEA is used during design to prevent
failures. Later, it is used for control before
and during operation of the process. Ideally,
FMEA begins during the earliest conceptual
stages of design and continues throughout the
life of the product or service. It is a
step-by-step approach for identifying all
possible failures in a design, a
manufacturing or assembly process, or a
product or service.
To see an FMEA example from The Quality
Toolbox, go to this ASQ web
page.
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ISO 9001:2009 - Clause 7 Changes |
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In the last newsletter, I reviewed the
proposed changes for clauses 5 and 6 of the
draft ISO 9001:2009 standard. This month,
we'll look at the suggested changes for
clause 7, Product Realization.
7.1 Planning of Product
Realization
The only change to the text of clause 7.1 is
the addition of "measurement" as one of the
required activities to be determined during
the planning of product realization.
In planning product realization, the
organization shall determine the following,
as appropriate:
c) required verification, validation,
monitoring, measurement,
inspection and test activities specific to
the product and the criteria for product
acceptance;
7.2 Customer-Related Processes
7.2.1 Determination of Requirements
Related to the Product
The slight change of "for delivery and
post-delivery activities" to "for delivery,
and for post-delivery activities" adds
emphasis to post-delivery activities. In
addition, a Note has been added with examples
of post-delivery activities.
The organization shall determine:
a) requirements specified by the customer,
including the requirements for delivery,
and for post-delivery
activities,
The change below from "related" to
"applicable" shifts the meaning from
determining legal requirements that are
merely associated with the product to those
that are relevant and can be applied to the
product.
c) statutory and regulatory requirements
related
applicable to the product, and
The revision below clarifies that the
additional requirements aren't just
determined, they are determined to be needed
by the organization. Since the bulleted list
begins with "The organization shall
determine", the use of the word "determined" again in the this entry was not appropriate.
d) any additional requirements as
needed
determined by the organization.
Readers of the current standard may have not
have considered the breadth of post-delivery
activities as described by the new Note
below.
NOTE: Post
delivery activities may include actions under
warranty provisions, contractual obligations
such as maintenance services, and
supplementary services such as recycling or
final disposal.
7.3 Design and Development
7.3.1 Design and Development
Planning
Clause 7.3.1.b states the organization must
determine the review, verification, and
validation appropriate for each design and
development stage. The new Note below
explains that although review, verification,
and validation have distinct goals, they can
be carried out separately or in any
combination.
NOTE: Design and
development review, verification and
validation have distinct purposes. They may
be conducted and recorded separately or in
any combination as suitable for the product
and the organization.
7.3.2 Design and Development
Inputs
This clause requires the design and
development inputs to be determined and
records to be maintained. It lists several
types of requirements to be included. The
revision below simply changes from "These
inputs" to "The inputs".
These
inputs shall be reviewed for adequacy.
Requirements shall be complete, unambiguous
and not in conflict with each other.
7.3.3 Design and Development
Outputs
The change below removes the unnecessary
word, "provided". It also switches from "a
form that enables verification" to "a form
suitable for verification". To enable
something is to make it possible. However, to
be suitable means it is meant for use, or in
this case, for verification.
The outputs of design and development
shall be
provided in a form that
enables
suitable for verification against the
design and development input and shall be
approved prior to release.
The text below only strikes "for" and doesn't
alter the requirement to share design
information with the purchasing, production,
and service organizations.
Design and development outputs shall:
b) provide appropriate information for
purchasing, production and for
service
provision,
The new Note below reminds the reader that
clause 7, Production and Service Provision,
includes sub-clause 7.5.5, Preservation of
product. Why do that? Probably to indicate
that the design output should consider
product preservation, e.g., product
packaging.
NOTE: Production
and service provision includes preservation
of the product.
7.5 Production and Service Provision
7.5.2 Validation of Processes for
Production and Service Provision
The requirements of clause 7.5.2 are most
often applied to "special processes" in
manufacturing where the resulting output
cannot be verified by subsequent measurement,
or when deficiencies become apparent only
after the product is in use. Readers may
overlook that this requirement also applies
to "service". The new Note below makes that
distinction.
NOTE 1: For many
service organizations, the service provided
does not readily allow the verification
before the delivery of the service. These
types of processes should be considered and
identified during the planning stage (see
7.1).
The new Note below gives examples of
production and service processes that
typically require validation to demonstrate
their ability to achieve planned results.
NOTE 2: Processes
such as welding, sterilization, training,
heat treatment, call center service, or
emergency response may need validation.
7.5.3 Identification and
Traceability
This clause states that, where appropriate,
the organization must identify the product by
suitable means "throughout product
realization". The text below refers to
inspection and test status of the product,
and some readers may have thought it only
applied to final product. The planned
revision below clarifies that identifying the
product status applies throughout product
realization, from received product, through
in-process product, to final product.
The organization shall identify the
product status with respect to monitoring and
measurement requirements throughout product
realization.
By moving the "records" reference to the end
of the sentence below, the meaning has
changed from recording the product
identification, to keeping any type of record
associated with product traceability.
Where traceability is a requirement, the
organization shall control and record
the unique identification of the product
and maintain
records (see 4.2.4).
7.5.4 Customer Property
The change below reads better, but hasn't
changed the requirement to report customer
property issues to the customer and keep
records.
If any customer property is lost, damaged
or otherwise found to be unsuitable for use,
this shall be
reported to the customer and records
maintained the organization shall report
this to the customer and maintain
records (see 4.2.4).
The existing Note has been modified to
include "personal data" as an example of
customer property, broadening the
applicability of clause 7.5.4 to more
organizations, especially service
organizations.
NOTE: Customer property can include
intellectual property and personal data.
7.5.5 Preservation of product
If anyone was confused over the meaning of "conformity of product" in the current text,
using "conformity to requirements" should be
easier to understand in the new text.
The organization shall preserve the conformity
of product during internal
processing and delivery to the intended
destination in order
to maintain conformity to requirements.
The current requirement that begins with, "This preservation shall include", doesn't
give the flexibility to include, or not
include, the identification, handling,
packaging, storage, and protection of the
product. The change below allows product
preservation to be applied as appropriate.
This As
applicable, preservation shall
include identification, handling, packaging,
storage and protection. Preservation shall
also apply to the constituent parts of a
product.
7.6 Control of monitoring and measuring
devices
The only change to this clause is the removal
of the reference to clause 7.2.1,
Determination of Requirements Related to the
Product.
The organization shall determine the
monitoring and measurement to be undertaken
and the monitoring and measuring devices
needed to provide evidence of conformity of
product to determined requirements (see
7.2.1)
.
Stating that measuring equipment must "be
identified" sounds like the organization is
to add identification. However, the measuring
equipment may come with the identification
already in place, thus the wording change
below. In addition, measuring equipment is a
term that typical covers multiple devices, so
the text has been changed from "the" to
"their" calibration status.
Where necessary to ensure valid results,
measuring equipment shall:
c. be
identified have identification to
enable the
their calibration status to be
determined;
ISO 10012:2003, Measurement Management
Systems - Requirements for Measurement
Processes and Measuring Equipment, replaced
the ISO 10012-1 and ISO 10012-2 standards, so
the reference was changed in the Note. Since
other Notes were added, the first Note became
Note 1.
NOTE 1: See
ISO 10012-1 and
ISO 10012-2 for guidance
further
information.
Clause 7.6 states that the organization must
determine the monitoring and measuring "devices" needed to provide evidence that the
product conforms to requirements. The Note
below explains that these devices may be
measuring equipment or other types of devices
used to monitor conformity to requirements.
NOTE 2:
Monitoring and measurement devices include
measuring equipment (whether used for
monitoring or measurement) and devices other
than measuring equipment that are used for
monitoring conformity to requirements.
Software development organizations may have
been unsure how to confirm, per clause 7.6,
that their software used for monitoring and
measurement has the ability to satisfy the
intended application. This new Note explains
that it should include verification and
configuration management for the software.
NOTE 3:
Confirmation of the ability of computer
software to satisfy the intended application
would typically include its verification and
configuration management to maintain its
suitability for use.
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ASME Measurement Uncertainty Standard |
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The National Institute of Standards and
Technology (NIST) engineers, together with
colleagues from industry and other standards
organizations, have completed a five-part
series of standards designed to evaluate the
accuracy and usability of manufacturing
measurements.
The American Society of Mechanical Engineers
(ASME) recently published the last in the
series, B89.7.3.2
- 2007, Guidelines for the Evaluation of
Dimensional Measurement Uncertainty. A copy can be obtained for
$35.00. Click on
the title above to go to its ASME Product
Catalog entry.
B89.7.3.2 - 2007 addresses the evaluation of
dimensional measurement uncertainty, with an
emphasis on simplified methods for the
industrial practitioner. Its introductory
methods are consistent with the Guide to the
Expression of Uncertainty in Measurement
(GUM), the nationally and internationally
accepted method to quantify measurement
uncertainty.
The five-part series describes ways that
measurement personnel can communicate,
evaluate, and respond to uncertainties in
manufactured part measurements. Adopting
these standards on the shop floor should
enhance manufacturing productivity and
minimize the scrapping of acceptable parts,
unnecessary rework, and even litigation.
In the past, shop engineers could relax if
component parts varied slightly from
specification. Parts just had to "fit
together." However, the complexity of many
current products requires more advanced
measurement capabilities. The ASME standards
are needed because measurements often vary
each time they are made (even the temperature
of the part can change the measurement result
by a significant amount).
The B89.7 series also explains dimensional
measurement traceability. Traceable
measurements demonstrate the connection
between the standard international (SI) unit
of length (the meter) and the task-specific
measurement under consideration; this also
requires an uncertainty statement describing
the accuracy of the measurement result.
The B89.7 series addresses:
- the role of measurement uncertainty when
accepting or rejecting products based on a
measurement result and a product
specification;
- economically efficient methods to
overcome differences between two parties in
the evaluation of measurement uncertainty;
- how to determine the economically
appropriate decision to accept or to reject a
product due to measurement uncertainty; and
- ways to demonstrate dimensional
measurement traceability to the SI unit so
that all parties can be sure of the
reliability of their measurements.
NIST researchers chaired the ASME B89.7
working groups and contributed to other
related development work during the
five-years it took to develop the five
standards. For information on the ASME B89.7
standards, click on this ASME
Product Catalog web page.
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TL 9000 R4.0 Requirements |
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The TL 9000 standard (based on ISO 9001:2000)
specifies requirements for suppliers of
telecommunications products: hardware,
software, and/or services.
A summary document that identifies the unique
TL 9000 Release 4.0 requirements has been
placed in the Resources
section of our web site. The ISO 9001:2000
clause numbers and titles have been boxed in
the text to set them off from the TL 9000
R4.0 requirements. The ISO 9001:2000
requirements were not included since the
focus of the document is on the TL 9000 R4.0
adders.
TL 9000 identifies its extra requirements as
being C = Common, or specific to Hardware
(H), Software (S), Services (V), or unique to
Hardware-Software (HS) or Hardware-Services
(HV). See a copy of the TL 9000 R4.0 Handbook
for the full text of the actual TL 9000 R4.0
requirements.
For more information about the TL 9000 R4.0
Handbooks, see the article in our March
2007 newsletter. An excerpt from the
summary document at our web site is shown
below.
| 5.3 Quality Policy |
| 5.4 Planning |
| 5.4.1 Quality Objectives |
5.4.1.C.1 Quality Objectives
Include quality targets for the measurements
in the TL 9000 Measurements Handbook.
| 5.4.2 Quality Management System
Planning |
5.4.2.C.1 Long and Short Term Quality
Planning
Include long and short-term plans with goals
for improving quality and customer
satisfaction. Monitor and report performance
to these goals.
These plans must address the business factors
relevant to the organization and its
customers, including performance objectives
established jointly with selected
customers.
5.4.2.C.1 - Note 1
Example factors that might be considered for
planning are cycle time, customer service,
training, cost, delivery commitments, and
product reliability.
5.4.2.C.1 - Note 2
Top management should demonstrate their
active involvement in the long and short-term
quality planning.
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Class Schedule |
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