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Goals and Objectives of Changes to AS9100
Emphasis on product and process improvement (e.g. risk management,
critical items, project management)
Expand the AS9100 scope to include Aviation, Space & Defense
Provide additional focus on objective of on-time and on-quality
deliveries
Ensure AS9100 standard is compatible for use by all stakeholder
segments and by organizations of all types and
sizes
Ensure AS9100 stays recognized by authorities
Ensure extensive stakeholder involvement in revision effort by the use
of a project management approach to solicit
input and manage the revision.
Summary of Significant Changes in AS9100C
7.1.1 Project Management
New requirement for planning and managing product realization in a
structured and controlled way.
7.1.2 Risk Management
New requirement to implement risk management process
applicable to the projects & products;
responsibility, criteria, mitigation & acceptance.
7.1.3 Configuration Management
Moved from clause 4.3 to clause 7.1 and added details on the different
activities to be covered.
7.1.4 Control of Work Transfer
Moved from clause 7.5 (Production) to clause 7.1 to add emphasis on
having a process for planning and control of
transfer activities.
Product quality and on-time delivery performance
Added requirement to measure "product conformity" and "on-time delivery" and
take appropriate actions if
planned results are not achieved. The intent is to provide a linkage
between the QMS and organization performance.
Process to be required to address control of Special Requirements,
Critical Items and Key Characteristics
Key characteristic requirements remain unaltered but a new concept is
added to identify special requirements from
the Customer or internal sources that require additional controls
(e.g. risk management) that translates into
Critical Items that may flow to Key characteristics for variation
control.
Formal monitoring of Customer satisfaction data
Added the requirement to monitor data and to develop improvement plans
that address deficiencies. The intent is to
promote continuous improvement of the product and Customer satisfaction.
Requirements from regulatory authorities.
A general requirement has been introduced in 4.1 to address all the
applicable statutory and regulatory QMS
requirements in the organization's QMS instead of keeping detailed
requirements in chapters.
First Article Inspection (FAI) moved to clause 7.5.1.1 and renamed.
Production process verification "FAI" is the requirement to validate
the production process's documentation and
tooling and repeat the process when necessary (i.e. when engineering or
manufacturing processes change). The
requirement was moved from 8.2.4.2 (measurement) to 7.5.1.1 (production)
because it is part of product realization
and is not intended to be a follow-on activity.
Difference between Key Characteristics, Special Requirements and Critical
Items.
Special Requirements are those requirements that have high risks to
being achieved, which require their inclusion
in the risk management process.
Critical Items, including key characteristics, are those items that have
significant effect on product
realization and use of the product, which require specific actions to
assure they are adequately managed.
ISO 10007 is referenced after Configuration Management.
ISO 10007 is included in a Note for reference only.
ISO 9001 changes affect AS9100:2009.
The AS9100 standard has been updated to stay consistent with ISO 9001,
which will continue to be the baseline. The
changes being incorporated into ISO 9001 are considered an amendment and
minor in nature.
Length of time to transition to AS9100:2009.
30 months. Companies will be encouraged to upgrade on their scheduled
audit cycle.
New "Scope" statement suggests alternate registrations.
If an organization applies multiple standards in addition to AS9100,
such as AS9110 (Maintenance) or AS9120 (Distributor), then the
registration requirements should be determined by Customer and
regulatory requirements. More than one standard registration may be
necessary if the Company provides other industry-standard products or
services according to its scope
of business activities (i.e. a Company that manufactures products and
also sells maintenance services). Clause 1.2 Introduction outlines the
new applicability statements for AS9100,
AS9110 and AS9120.
Deleted text from Clause 4.2.2 Quality Manual Relationships.
The deletion of the requirement to create a document showing the
relationship between AS9100 requirements and the
organization's documented procedures was seen as adding no value to
assuring product quality above the existing ISO
text. Users of AS9100 will still need to identify appropriate documented
procedures as an inherent part of carrying
out an audit.
Clause 1
- AS9100 Scope and Application
Revision: Scope extended to include Defense as well as Aviation and Space.
Application guidance provided when AS9100, AS9110 and AS9120 are
appropriate for use.
AS9101 will incorporate AS9111 and AS9121 audit requirements.
Reason:
The AS9100 QMS is applicable to other complex quality management systems and would
receive benefit from implementation
including land and sea applications.
Possible additional recognition and synergies with NATO Allied
Quality Assurance Publications (AQAPs).
Considerations:
Increased use and improved understanding of when the various
aviation, space and defense standards are
applicable.
Clause 3.1
- Risk
Addition:
Define new term "risk"
An undesirable situation or circumstance that has both a likelihood
of occurring and a potentially negative
consequence.
Reason:
The understanding of risk is important for an organization to develop a
proactive quality management system
Considerations:
Understanding this term is important to implement a risk management
process in the applicable clauses.
Clause 3.2
- Special Requirements
Addition:
Define new term "special requirements"
Those requirements that have high risks to being achieved thus
requiring their inclusion in the risk management
process.
Factors used to determine special requirements include:
- past experience
- product or process complexity
- product or process maturity.
Examples include:
- performance requirements imposed by the Customer that are at the limit
of the industry's capabilities
- requirements determined by the organization to be at the limit of its
technical or process capabilities
Reason:
Improve understanding of "Special Requirements" and the potential
chain of flow to "Critical Items" and to "Key
Characteristics."
Ensure these important requirements are systematically addressed and
linked to risk management activities by the
organization.
Considerations:
Understanding this term is important to implement special requirement
processes in the applicable clauses.
Clause 3.3
- Critical Items
Addition:
Define new term "critical item"
Those items having significant effect on the product realization and
use of the product (e.g. functions, parts,
software, characteristics, processes); including safety performance, form,
fit, function, producibility, service life,
etc. that require specific actions to ensure they are adequately
managed.
Examples of critical items include:
- fracture critical items
- key characteristics
- mission critical items
- safety critical items
Reason:
Improve understanding of "Critical Items" coming from Special
Requirements.
Ensure these items are systematically addressed and linked to risk
management activities by the organization.
Considerations:
Understanding this term is important to implement critical item(s)
processes in the applicable clauses.
INTERRELATIONSHIP BETWEEN SPECIAL REQUIREMENTS, CRITICAL ITEMS, KEY
CHARACTERISTICS AND RISK MANAGEMENT PROCESS
Clause 4.1
QMS General Requirements
Revision/Relocation: The organization's QMS shall address Customer and applicable
statutory and regulatory QMS requirements
(previously located in the QMS documentation 4.2.1).
Reason:
Clarify that the requirement is placed at the QMS level and not only
at the documentation level.
Considerations:
The concept of "basic QMS" may be used (processes applicable to all
Customers / activities) but the documents
such as Quality Management Plans that address specific Customers
requirements shall be considered as part of the
QMS.
Clause 4.2.2
Quality Manual Relationships
Deletion: Requirement to create a document showing the relationship between
AS9100 requirements and the organizations
documented procedures.
Reason:
Requirement adds no value to assuring product quality.
Requirement was viewed as prescriptive in that it specifies a
particular method of assuring the requirements of
the standard have been met.
Considerations:
Auditors need to identify appropriate documented procedures as an
inherent part of carrying out the audit.
Clauses 5.2/8.2.1
Customer Focus/Satisfaction
Addition: Top management shall ensure that product conformity and on-time
delivery performance are measured and that
appropriate action is taken if planned results are not or will not be
achieved. (5.2)
Information to be monitored and used for the evaluation of Customer
satisfaction shall include but is not limited
to:
- corrective action requests.
- Customer complaints
- on-time delivery performance
- product conformity
Organizations shall develop and implement plans for improvement of
Customer satisfaction that addresses
deficiencies identified by these evaluations and assess the
effectiveness of the results.
(8.2.1)
Reason:
Establish clear relationship between the QMS and organizational
performance in line with AS9100 strategy.
To promote continuous improvement of Customer satisfaction.
Considerations:
Review of management focus and organizational process to measure
Customer satisfaction and plan improvements
7.1.1
- Project Management
Addition: New requirement for planning and managing product realization in a
structured and controlled way to meet
requirements at acceptable risk within resource and schedule
constraints.
Reason:
Most aviation space and defense products are complex and involve
multi-tier partners and suppliers.
This clause provides additional focus on upfront planning and the
management of project plans throughout product
realization.
Considerations:
The organization must have a process to manage product realization
planning to ensure quality and schedules are
not compromised.
Project plans should be used to manage the successful completion of
projects.
7.1.2
- Risk Management
Addition: New requirement to implement a risk management process applicable to
the product and organization covering:
responsibility, criteria, mitigation and acceptance.
The concept of risk is integrated within the revised AS9100.
Reason:
Risk Management was placed in clause 7.1.2 to provide additional
focus on product risk during product
realization.
Considerations:
The organization must have a risk management process that addresses
all of the applicable requirements, such as
verification of chemical/physical test reports.
The definition of risk must be appropriately understood and applied in
that process.
Risks must be successfully managed in the organization.
7.1.3
- Configuration Management
Revision/Relocation: Moved from Clause 4.3 to 7.1.3.
Structured in line with ISO 10007 requirements.
Reason:
Focuses configuration management on the product and how it is
sustained throughout product realization.
Considerations:
Some level of configuration management is expected for all products
at all levels of the supply chain in
compliance with exclusion criteria (see clause 1.2).
7.1.4
Work Transfer
Revision/Relocation: Moved from clause 7.5.1.4 (Production) to clause 7.1.4
The organization must have a process to plan and control the transfer
activities.
Expanded to cover permanent transfer (e.g. from one organization to
another, from one organization to supplier,
from one supplier to another).
Reason:
Work transfer can occur at anytime during product realization.
Addresses problems that often occur during work transfers .
Considerations:
A process must exist to control the transfer of work including
planning and subsequent control of the transfer.
Clause 7.4.1
Recognition of Supplier Quality Data
Revision: Added note to recognize that one factor that may be used during
supplier selection and evaluation is "objective
and reliable data from external sources".
Reason:
Recognition that the industry trend is to use externally provided
supplier performance data (e.g. Online
Aerospace Supplier Information System OASIS, Nadcap)
Considerations:
Note only
Clause 7.4.1
Approval status for suppliers
Revision: Added and provided examples of "approval status" (e.g. approved,
conditional, disapproved) and examples of "scope
of approval" (e.g. product type, process family).
The organization must define the process for supplier approval status
decisions or changes.
Reason:
Clarify that the conditions for using a supplier depends on its
approval status.
Considerations:
The process responsibilities and authority must be defined for this
process.
Clause 7.4.3
Validation of Test Reports
Deletion:
Where the organization utilizes test reports to verify purchased
product, the data in those reports shall be
acceptable per applicable specifications. The organization shall
periodically validate test reports for raw
material.
Reason:
Misunderstood concept that was frequently misapplied.
Requirement was prescriptive, not applicable to all stakeholders
(especially small organizations) and for all
types of products and was subject to varying interpretation.
Considerations:
The organization must verify test reports as part of the risk management
process if it is making critical items where the material
chemical/physical requirements are important.
Clause 7.5.1.1
Production Process Verification
Revision/Relocation: Moved from 8.2.4.2 (measurement) to 7.5.1.1 (production)
Requirement to verify production process documentation and tooling
are capable of producing parts and assemblies
that meet requirements. This process shall be repeated when changes
occur that invalidate the original results (e.g.
engineering or manufacturing process changes tooling changes).
Reason:
Movement to clause 7 acknowledges that this requirement (previously
called first article inspection - FAI) is not
primarily a measuring and monitoring process but a process that will be
used to assure product realization
capability under controlled conditions.
Allows justifiable exclusion for unique and individual products.
Considerations:
Validation of requests for exclusion (unique and individual products
vs. production run).
Clause 8.2.2
Detailed Tools and Techniques
Deletion: "Detailed tools and techniques shall be developed such as check
sheets, process flowcharts or any similar method
to support audit of the quality management system requirements. The
acceptability of the selected tools will be
measured against the effectiveness of the internal audit process and
overall organization performance."
Reason:
Requirement was too prescriptive - reference to specific tools in a
"such as" statement is more appropriate as
guidance material.
Considerations:
Methods and effectiveness measures remain intact in the ISO text.
Tools and techniques may still be needed to
support the audit process.
Clause 8.2.4
Sampling Inspection
Revision: When the organization uses sampling inspection as a means of product
acceptance, the sampling plan shall be
justified on the basis of recognized statistical principles and
appropriateness for use (i.e. matching the sampling
plan to the criticality of the product and to the process capability).
Reason:
Numerous requests were received to improve clause 8.2.4. The comments
ranged from it was statistically inaccurate
to comments that it was too prescriptive.
Considerations:
Validation of recognized statistical principles utilized.
Process used to determine criticality of product.
Allowable time for Recertification
Maximum 30 month Implementation from Publication date (January 2009).
