Transcript Comparison between 1st and 2nd edition

How the ISO/TS 16949 Additions have moved
from 1st to 2nd edition
Element
Number
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
X/X
Element
4.0
0/1
Most Additions
Total
Applied Within Removed Added
Additons
Element
5.0
6.0
7.0
8.0
1/6
1/1
1/2
1/2
4/11
5.0
1
0/1
1/1
3/13
0/2
4/18
7.0
1
0/1
0/1
7.0
1
0/7
0/8
7.0
0/2
4.0
1
0/1
0/5
7.0
1 note
0/1
0/1
7.0
0/4
0/2
2/6
7.0
1/2
0/2
1/4
8.0
1/2
1/1
7.0
1/1
7.0
2/2
8.0
0/1
0/1
0/4
2/1
1/1
4
Sub-element
1 note
1
2 notes
How the ISO/TS 16949 Additions have moved
from 1st to 2nd edition
Element
Number
4.0
5.0
6.0
7.0
4.14
4.15
4.16
4.17
4.18
4.19
4.20
Summary of
additions
X/X
Element
0/2
8.0
Most Additions
Total
Applied Within Removed Added
Additons
Element
0/5
0/4
8.0
0/1
0/7
7.0
0/1
4.0
1/4
8.0
2
6.0
0/1
0/6
1/2
0/2
1/2
1/7
Sub-element
5/5
9/36
7.0
2
2
8.0
7/21
25/74
7.0
4 subelements
1 note
11*
3
Summary of Changes
• A majority of additions to First Edition migrate to
7.0 Product Realization, 8.0 Measurement,
Analysis and Improvement and 6.0 Resources in
Second Edition.
• Just 2 additions from 1st edition to 2nd edition 6.5 Sourcing, 7.1.2 Change Control
• Changes have not been made in 17 areas
• A change is made to the language of almost every
requirement, whether a change to the wording or
removal of a term
Comparison between 1st and 2nd edition
4.1 – Management Responsibility
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.1.1.2 Objectives
5.4.1.1 – Quality
Objectives –
Supplemental
Changed to “Top management shall define
quality objectives and measurements in the
business plan to deploy the quality policy.
4.1.1.3 Customer
Satisfaction
8.2.1.1 – Customer
satisfaction –
Supplemental
Removed “Documented Process”
Monitored through Performance indicators.
Mandatory indicators are Delivered part
quality performance, Customer disruptions
including field failures, Delivery schedule
performance (including premium
freight),Special status customer notifications
relating to quality or delivery issues
Added “The organization shall monitor
manufacturing processes’ performance to
demonstrate compliance with customer
requirements for product quality and
efficiency of the process.
Comparison between 1st and 2nd edition
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.1.1.4 Continuous
Improvement
5.3.1 Quality Policy –
Supplemental
Moved only the first sentence “Continuous
improvement in quality, service, cost ,
technology shall be provided for in the
Quality policy” as a separate element 5.3.1
4.1.1.4 – Remaining
requirements
8.5.5.1 –
Organizational
continuous
improvement
Wordings changed “Shall define a process
for continual improvement”
Note 1 and Note 2 deleted
4.1.2.1.2 – Customer
representative
5.5.2.1 – Customer
representative
Minor wording changes
4.1.2.1.3 - Quality
responsibility
5.5.1.1 – Quality
Responsibility
Minor wording changes
4.1.2.2.2 – Shift
resources
5.5.1.1 – Quality
Responsibility
Minor wording changes
Comparison between 1st and 2nd edition
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.1.2.4 – Organizational
interfaces
7.3.1.1 – Multi –
Disciplinary approach
7.2.3.1 – Customer
communication
supplemental
Removed “The supplier shall have systems
in place….. According to customer advance
product quality planning and control plan
manual.”
Retained “The organization shall have the
ability to communicate necessary
information including data in a customer
specified language and format, (e.g.
computer-aided design data, electronic data
exchange,…) “
4.1.3.2 Management
review – Supplemental
4.2.8 – Quality system
performance
(Above elements are
moved to 5.6.1.1)
5.6.1.1 – Quality
management system
performance
5.6.2.1- Management
review – supplemental
•
Minor wording changes.
•
Added “Analysis of field failures and
their impact on quality, safety or the
environment shall be input to
management review”
Comparison between 1st and 2nd edition
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.1.4 – Business Plan
Removed
Reference is there in 5.4.1.1 and 5.6.1.1, but
there requirements of 4.1.4 is missing, not
even in Parking lot
4.1.5 – Analysis and use
of Company level data
8.4.1 – Analysis and
use of company level
data
•
Removed” Supplier shall document
trends in quality, operational
performance and current quality
objectives” (Still reviewing Cost of poor
quality is mandatory under 5.6.1.1)
4.1.6 – Employee
motivation,
empowerment and
satisfaction
6.2.2.4 – Employee
motivation,
empowerment and
satisfaction
•
•
•
Removed “Employee satisfaction process”
Note deleted.
This should be 6.2.2.4. There is an error in
the standard in the numbering
4.1.7.1 Product Safety
6.4.1 Safety
•
Removed “Potential risks to Customers,
users and the environment”. Only “Risk
to employees” is there
4.1.7.2 – Regulations
7.2.1 – Determination
of requirements
relating to product
Added as Note-2
Comparison between 1st and 2nd edition
4.2 Quality Systems
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.2.2.2 – Quality System
documentation
4.2.1 – General
Note added: At the moment in Parking lot
4.2.3.2 – Quality Plan
requirements
7.1.1 – Quality Plan
requirements
Word “appropriate” is removed
4.2.4.1 – Product
Realization – General
7.1 – Product
realization
•
•
Only Note-1 retained. Requirements
relating to project management approach
and a project team is removed
Significant removal “Confidentiality of
customer-contracted products and
projects under development and related
product information
4.2.4.2 - Measurements
7.3.4.1 – Monitoring
•
“These measurements shall include
quality risks, costs, lead-times, critical
paths” moved to Notes.
4.2.4.3 – Review cycle
7.3.4.1 – Monitoring
Removed the requirement. Note still there
Comparison between 1st and 2nd edition
4.2 Quality Systems
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.2.4.4 –
Multidisciplinary
approach
7.3.1.1 – Multi
disciplinary approach
No Change
4.2.4.5 Tools and
techniques
8.2.3.1 – Monitoring
and measurement of
processes –
Supplemental
•
Last para “The supplier shall perform
process studies…… as well as
acceptance criteria” is moved to this
element
4.2.4.5 Tools and
techniques
7.3.3.1 – Product
design outputs
7.3.3.2 – Process
design outputs
•
In this “Use of product mistake proofing
is added.
This already contains “Mistake
proofing”, this is retained in the same
element.
First two sentences in 4.2.4.5 is removed
•
•
4.2.4.6 – Computer aided
design
6.2.2.1 – Product
design skills
•
Entire 4.2.4.6 is removed. Instead one
sentence “Applicable tools and
techniques shall be identified by the
organization” is there in 6.2.2.1
Comparison between 1st and 2nd edition
4.2 Quality Systems
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.2.4.7 – Special
characteristics
7.3.2.4 – Special
characteristics
•
•
“appropriate methods” removed
Note –2 removed
4.2.4.8 – Feasibility
reviews
7.2.2.1 –
Manufacturing
feasibility
•
“including risk analysis” added
4.2.4.9.1 – Management
of Process design –
General
Removed
•
Removed – Documentation
requirements removed
4.2.4.9.2 – Process
design inputs
7.3.2.2 –
Manufacturing process
design input
•
“applicable regulations” removed
4.2.4.9.3 – Process
design output
7.3.3.2 –
Manufacturing process
design output
•
“manufacturing process flow
chart/layout” added
“Control plan” added
•
Comparison between 1st and 2nd edition
4.2 Quality Systems
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.2.4.9.4 – Process
verification
7.3.5 – Design and
Development
verification
This is part of Design and Development
verification since now Design and Development
includes “Product and Process design” which is
added at the beginning of 7.3 under title
“Important”
4.2.4.10 – Control Plan
7.5.1.2 – Control Plan
•
“prototype control plan when required
by customer” removed
4.2.4.11 – Product
Approval Process
7.3.6.3 – Product
Approval Process
•
First two requirements including two
notes are moved to 7.3.6.3
4.2.4.11 – Product
Approval process
7.3.7.1 – Control of
Design and
development changes –
supplemental
•
Requirements relating to change
moved to 7.3.7.1
Note added as : See 7.1.2
7.1.2 – Change Control
•
•
New requirement added incorporating
Change requirements
Comparison between 1st and 2nd edition
4.2 Quality Systems
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.2.5 – Plant, facility and
equipment planning
6.3.1 – Plant, facility
and equipment
planning
“Plant layouts shall minimize material
travel” changed to “Plant layouts shall
optimize material travel”
In Methods shall be developed, added
“implemented”
Note removed
4.2.6 – Tooling
management
7.5.1.6 – Tooling
management
•
•
Minor wording changes
Note added : “This requirement also
applies to tooling availability for
vehicle spare parts”
4.2.7 – Process
Improvement
8.5.1.2 –
Manufacturing Process
Improvement
•
•
Minor wording changes.
2 notes deleted and two new notes
added
4.2.8 – Quality System
performance
5.6.1.1 – Quality
Management System
performance
•
This requirement incorporated along
with 4.1.3.2 – Management review
supplemental
Comparison between 1st and 2nd edition
4.3 Contract review
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.3.2.2 – Review –
Supplemental
Removed
This requirement is removed
Comparison between 1st and 2nd edition
4.4 Design Control
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.4 Design Control –
Important
7.3 – Design and
Development
Added “The requirements of 7.3 are
applicable to Product and manufacturing
design and development and should focus on
error prevention rather than detection”. This
is a big change
4.4.2.2 Required skills
6.2.2.1 – Product
design skills
•
•
4.4.2.3 Research and
Development
7.3.2.3 Innovation
•
•
•
Just says that Suppliers resources
should be qualified to achieve design
requirements and skilled tools and
techniques.
List of skills has been removed
Just says that Organization shall have
a process for innovation in product
and process
Removed “access to R&D facilities”
Right now in Parking lot
Comparison between 1st and 2nd edition
4.4 Design Control
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.4.4.2 Reliability
Objectives
7.3.2.1 – Product
design inputs
The existing requirement added as one of the
inputs to Product design
4.4.4.3 – Use of
information
7.3.2.1 – Product
design inputs
•
The existing requirement added as one
of the inputs to Product design
4.4.5.2 – Design
Optimization
7.3.3.1 – Product
design outputs
•
Minor wording changes. Product
outputs and the Optimization
processes clearly seperated out
4.4.8.2 – Design
Validation –
Supplemental
7.3.6.1 – Design and
development validation
– supplemental
•
At the moment, recording of design
failures and corrective actions is put
within brackets. Requirements are not
written in detail. First sentence
pertaining to customer timing is there
4.4.8.3 – Prototype
Programme
7.3.6.2 – Prototype
program
No Change
Comparison between 1st and 2nd edition
4.4 Design Control
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.4.9.2 – Evaluation of
design change
7.3.7.1 – Control of
design and
development changes Supplemental
No change. Incorporated as part of 7.3.7.1
In 7.3.7 note added “Design changes include
all changes during the life cycle of the
product”
Note “This includes changes to proprietary
designs” removed
Comparison between 1st and 2nd edition
4.5 Document and data control
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.5.2.1 Note
Removed
Note is Removed
4.5.2.2 Engineering
specifications
4.2.3.1 – Engineering
Specifications
•
•
Word “procedure removed” and
“process” added
2 notes currently present removed
Comparison between 1st and 2nd edition
4.6 Purchasing
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.6.1.1 Note
Note removed and
added two notes under
7.4.1
Note removed pertaining to Definition 3.1 in
ISO9001”1994
2 Notes added:
Note-1 “Purchased products above includes
all products and services that impact
customer requirements such as sorting,
rework and calibration services”
Note-2 “where there are mergers,
acquisitions and affiliations associated with
suppliers, the organization should verify the
continuity of suppliers quality system and
effectiveness”
4.6.1.2 – Customer
approved subcontractors
7.4.1.4 Customer
approved sources
•
“including tool and gaging suppliers”
added
4.6.1.3 – Regulatory
compliance
7.4.1.2 – Regulatory
compliance
•
“applicable to country of manufacture
and sale” removed
Comparison between 1st and 2nd edition
4.6 Purchasing
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.6.2.2 – Subcontractor
development
7.4.1.3 – Supplier
Quality management
system development
Added “As a minimum the supplier shall be
compliant with ISO9001:2000”. This could
be a big change
Note 2 relating to prioritization removed
Note 1 – Minor changes in wordings
4.6.2.3 – Scheduling
subcontractors
8.2.4.3 – Supplier
Monitoring
•
“Shall require 100% on time delivery
and providing planning information
and purchase commitments” removed.
Only Delivery performance tracking
and premium freight tracking retained
Comparison between 1st and 2nd edition
4.7 Control of customer supplied product
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.7.2 – Customer owned
tooling
7.5.4.1 – Customer
owned tooling
“manufacturing,test,inspection tooling and
equipment” added.
Comparison between 1st and 2nd edition
4.8 Product identification and traceability
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.8
7.5.3 – Product
Identification and
traceability
No change
Comparison between 1st and 2nd edition
4.9 Process Control
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.9.1.2 Cleanliness of
Premises
6.4.2 – Cleanliness of
premises
Minor wording changes
4.9.1.3 – Contingency
plans
6.3.2 – Contingency
plans
•
4.9.1.4 – Designation of
special characteristics
7.2.1.1 – Customer
designated special
characteristics
Minor wording changes
4.9.1.5 – Preventive
maintenance
7.5.1.5 – Preventive
and predictive
maintenance
•
•
•
“to satisfy the customer specified
requirements” added
Natural disaster and force major removed
Minor wording changes
“Predictive methods to maximize the
effectiveness and efficiency of
equipments” added
Comparison between 1st and 2nd edition
4.9 Process Control
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.9.2 – Job instructions
7.5.1.3 – Work
instructions
“Job instructions” changed to “Work
instruction”
“without disruption of job” removed
“Job instructions shall include or reference
….” removed
Note 1 and Note 2 removed
4.9.3 Maintaining
process control
8.2.3.1 –Monitoring
and measurement of
processes –
Supplemental
•
•
4.9.4 Verification of jobsetups
7.5.1.4 – Verification of •
Job setups
•
Word “Setup is” missing. This is an
error.
“significant time period between runs”
removed
4.9.5 Appearance items
8.2.4.5 – Appearance
items
It is 8.2.4.4, should be 8.2.4.5. Minor
wording changes
•
Word “exceed” removed
Minor wording changes
Comparison between 1st and 2nd edition
4.10 Inspection and Testing
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.10.1.1 Note
Note removed
Existing note removed. New note pertaining
to selection of measurement types added. In
parking lot
4.10.1.2 Acceptance
criteria
8.2.4.1 – Acceptance
criteria
•
Changed to “Acceptance criteria shall
be defined by the customer and
documented by the organization”. This
is not clear
4.10.2.4 – Incoming
product quality
8.2.4.2 – Incoming
Product quality
•
“Shall have a process to assure quality
of incoming product”. When the
evidence says that quality is not good
then, the corrective actions to be
initiated using the following methods
“ Receipt of statistical data……”
This change means that it is not
mandatory to follow the 4 controls
listed as per the 1st edition. This is
required only as a corrective action
•
•
Comparison between 1st and 2nd edition
4.10 Inspection and Testing
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.10.4.2 – Layout
inspection and functional
testing
8.2.4.3 – Layout
inspection and
functional testing
No change
4.10.6 Laboratory
requirements
7.6.4 – Laboratory
requirements
7.6.4.1 – Internal Labs
7.6.4.2 – External Labs
•
•
•
•
•
Compliance with ISO/IEC 17025
removed. Now it is not mandatory.
Earlier requirements in QS9000:1998
written as mandatory in 2nd edition.
Lab “shall be included in the quality
system”
“Evidence of external lab acceptable to
the customer” is required if the external
lab is not an accredited lab
2 notes added pertaining on how the
customer acceptance of lab can be
demonstrated.
This could be a big change
Comparison between 1st and 2nd edition
4.11 Control of inspection, measuring and test equipment
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.11.1.2 – Measurement
System Analysis
7.6.1 – Measurement
System analysis
Note added saying what requirements to be
applied for acceptance in the absence of
customer reference manuals (ISO10012-1
and ISO10012-2 to be used in such cases)
Existing Note deleted
4.11.3 – Records
7.6.2 – Calibration
records
•
“an assessment of the impact of the
out-of specification condition” added
Comparison between 1st and 2nd edition
4.12 Inspection and Test status
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.12 – Inspection and
Test status
7.5.3 – Product
identification and
traceability
No change. Merged with Product
identification and traceability
Comparison between 1st and 2nd edition
4.13 Control of nonconforming product
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.13.1.2 Suspect material
or product
8.3 – Control of
nonconforming product
“Visual identification for any nonconforming
product….” removed
Added “Important: Nonconforming includes
material of unknown or suspect status”
4.13.1.3 – Corrective
action plan
8.3.1 – Customer
information
•
•
“Customer information in case of
nonconforming product shipped” is
moved to this element
Requirement relating to quantify,analyze
and initiating actions removed
4.13.3 – Control of
reworked product
8.3.2 – Control of
reworked product
•
Minor wording change
4.13.4 – Engineering
approved authorization
8.3.3 – Customer
authorization
•
Change – “Shall obtain customer
authorization prior to changing
product/process”
Minor wording changes
•
Comparison between 1st and 2nd edition
4.14 Corrective and Preventive action
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.14.1.2 Problem solving
8.5.2.1 – Problem
Solving
“Shall have a process for problem solving
leading to root cause identification and
elimination” (Wording change)
4.14.1.3 Mistake
proofing
8.5.2.2 – Mistake
proofing
8.5.3.1 – Mistake
proofing in preventive
action
No Change
4.14.2.2 – Corrective
action impact
8.5.2.3 – Corrective
action impact
No change
4.14.2.3 – Returned
product test/analysis
8.5.2.4 – Returned
product test/analysis
•
•
“Rejected” should be “Returned”. This
is an error in the standard.
No change
Comparison between 1st and 2nd edition
4.15 Handling, Storage, packaging,preservation and delivery
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.15.3.2 – Inventory
7.5.5.1 – Storage and
inventory
No Change
4.15.4.2 Customer
packaging standards
Removed
Removed
4.15.4.3 – Labelling
Removed
Removed
4.15.6.2 – Performance
monitoring of supplier
delivery
8.2.1.1 –Customer
satisfaction –
Supplemental
•
•
•
•
“Delivery schedule performance
including premium freight” is one of
the indicators to be tracked
“Organization shall monitor process
performance to meet the customer
quality and efficiency of process”
(This is for lead time tracking).
Removed “Lead time requirements”
Removed the first sentence of current
4.15.6.2
Comparison between 1st and 2nd edition
4.15 Handling, Storage, packaging,preservation and delivery
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.15.6.3 – Production
scheduling
7.5.1.7 – Production
scheduling
Minor wording changes
4.15.6.4 – Electronic
communication
Removed
Removed
4.15.6.5 – Shipment
notification system
Removed
Removed
Comparison between 1st and 2nd edition
4.16 Control of Quality Records
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.16.2 Record retention
4.2.4.1 – Record
retention
No change
Comparison between 1st and 2nd edition
4.17 – Internal quality audits
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.17.2.1 – Internal
quality audits –
supplemental – General
8.2.2.1 – Internal audit
plans
Note pertaining to adherence to ISO10011-1
removed , since now meeting ISO10011-1 is
mandatory
4.17.2.2 – System audit
8.2.2.1 – Internal audit
plans
•
“Audits shall cover all activities and
shifts” moved to 8.2.2.1
8.2.2.2 – Quality
management system
audit
•
Remaining requirements of 4.17.2.2
are moved here. No change
4.17.2.3 – Process audit
8.2.2.3 –
Manufacturing Process
audit
•
Removed the word “Product
realization”. Now the focus is only on
manufacturing process.
4.17.2.4 – Product audit
8.2.2.4 – Product audit
•
No change
4.17.3 – Auditor
qualification
8.2.2.2 – Internal
auditor qualification
•
“Shall comply with ISO10011-2
requirements unless specified by
customer”. This is a big change.
Comparison between 1st and 2nd edition
4.18 – Training
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.18.1 – Training
6.2.2.2 – Training
Even though this is ISO9000:1994
requirement, this is not a requirement in
ISO9001:2000. In the 2nd edition, this along
with the 2 notes which were present in
ISO9000:1994 have been added in this
element without any change
4.18.2 Training
effectiveness
6.2.2.c
•
Effectiveness requirements is added
now as part of ISO9001:2000 6.2.2.c
6.2.2.2 – Training
•
“Special attention shall be given on
customer specific requirements” is
moved to 6.2.2.2
Note is removed
•
4.18.3 – Training on the
job
6.2.2.3 – Training on
the job
•
This should be actually 6.2.2.3. This is
an error in the standard in numbering.
No change
Comparison between 1st and 2nd edition
4.19 - Servicing
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.19.1 Servicing – Note
Note removed
4.19.2 Feedback of
information from service
7.5.1.8 – Feedback of
information from
service
No change
4.19.3 – Servicing
agreement with customer
7.5.1.9 – Servicing
agreement with
customer
•
Earlier it was “Special purpose tools”
now it is “Special purpose tools or
measuring equipments”
Comparison between 1st and 2nd edition
4.20 – Statistical techniques
TS 16949
1st edition
TS 16949 2nd
edition
Comments
4.20.3 – Identification of
statistical tools
8.1.1 – Identification of
Statistical tools
No change
4.20.4 – Knowledge of
basic statistical concepts
8.1.2 – Knowledge of
basic statistical
concepts
Word “where appropriate” removed
Comparison between 1st and 2nd edition
New requirements
TS 16949
1st edition
TS 16949 2nd
edition
Comments
-
6.5 Sourcing
“The organization shall identify qualified
sources of supply needed to realize products. To
maintain consistency and stability, sourcing
shall include a process to manage supplier
communication and improvement.”