Transcript Workshop - QMS Change Overview

IAQG
International Aerospace Quality Group
QMS Standards: Change Overview
Quality Management Systems (QMS)
For Aviation, Space and Defense
April 16, 2010
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Requirements Strategy Stream
Team Leadership
Team leadership:
• Team Mentor
Guy Dion (Zodiac Aerospace)
• Team Leader
Alan Daniels (Boeing)
• AAQG Leader
Buddy Cressionnie (Lockheed Martin)
• APAQG Leader
Masahiro Kawamoto (MHI)
• EAQG Leader
Guy Dion (Zodiac Aerospace) (Proposal)
Standards Leaders:
• 9100
Guy Dion (Zodiac)
• 9110
Jeff Wood (Boeing)
• 9120
Dale Gordon (MPC Products Corp)
• 9115
Michelle Pierce (Lockheed Martin)
• 9137
Francisco Losada (EADS CASA)
• 9101
Hans Luijt (OPMT)
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Standards Revisions
Revised in 2009
• 9100 - QMS – Requirements for Aviation, Space &
Defense Organizations
• 9110 - QMS – Requirements for Aviation & Defense
Maintenance Organizations
• 9120 - QMS – Requirements for Aviation, Space &
Defense Distributors
• 9101 – QMS – Aviation, Space and Defense QMS Audits
• 9115 – QMS Requirements for Aviation, Space and
Defense Organizations – Deliverable Software
Standards to be Cancelled (Combined in 9101)
• 9111 – QMS Assessment for Maintenance
Organizations
• 9121 – QMS Assessment Applicable to Stockist
Distributors
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Why 9100:2009?
• To standardize Aviation, Space & Defense
quality expectations on a global level
• To achieve improvements in quality and
reduce costs throughout the value stream
• ISO 9000 model for quality does not capture
regulatory requirements or importance of
safety, reliability or maintainability
• Captures aerospace supplements agreed to at
an international level
AS&D products are often complex and high risk
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ISO 9001 versus 9100
• 9100 version is formatted to match ISO 9001:2008
and added “requirements” that provide for:
– Regulatory organizations interfaces
– Project Management
– Risk Management
– Configuration Management
– Control of Work Transfers
– Design and Development V&V & V&V testing
– Control of changes in Production Process
– Control of production equipment, tools, NC machines
– Control of service operations
– Production process verification
• These added requirements enables a standardized
approach to supplier flow down requirements
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9100:2009 Key Changes
• Clause 3.1 – Risk Management
– An undesirable situation or circumstance that has
both a likelihood of occurring and a potentially
negative consequence
• Clause 3.2 – Special Requirements
– Those requirements which have high risks to being
achieved thus, requiring their inclusion in the risk
management process
• Clause 3.3 – Critical Items
– Those items (e.g., functions, parts, software,
characteristics, processes) having significant effect
on the product realization and use of the product;
including safety, performance, form, fit, function,
producibility, service life, etc. that require specific
actions to ensure they are adequately managed
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9100:2009 Key Changes
Interrelationship between Special Requirements, Critical
7.1 Planning of Product Realization
Items, Key Characteristics, and Risk Management process
Customer
Requirements
including
Requirements
identified as
special by the
customer
Statutory,
Regulatory,
and Other
Requirements
7.2
Determination
and Review of
Requirements
Related to the
Product
Special
Requirements
as determined
by customer or
organization
7.3 Design &
Development
Design
Inputs
Design
Outputs
7.3.3.e critical
items, including
Key
Characteristics
7.4
Purchasing Vendor/
Supplier
Provided
Products
7.4.2 flow
down req’t
to suppliers
7.5 Production
& service
provision
(Drawings,
Instructions,
Plans. etc.)
7.5.1
appropriate
processes to
manage
critical items
7.1.2 Risk Management
8.2.3/8.2.4 - Monitoring & Measurement of Processes/Products
8.4 Analysis of Data
8.5 Improvement (CI, C/A, P/A)
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9100:2009 Key Changes
• 7.1.1 – Project Management
– 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
• 7.1.2 – Risk Management
– 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
9100
• 7.1.3 – Configuration Management
– Moved from Clause 4.3 to 7.1.3
– Structured in line with ISO 10007 requirement
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9100:2009 Key Changes
• 7.1.4 – Work Transfer
– 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)
• Clause 7.4.1 – Recognition of Supplier Quality Data
– Added note to recognize that one factor that may be
used during supplier selection and evaluation is
objective and reliable data from external sources
• Clause 7.4.1 – Approval Status for Suppliers
– 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
suppliers approval status decisions or changes
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9100:2009 Key Changes
• 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
• Clause 7.5.1.1 – Production Process Verification
– Moved from 8.2.4.2 (measurement) to 7.5.1.1
(production)
– Requirement to verify the production processes,
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
processes changes, tooling changes) FAI
• Clause 8.2.4 –Sampling Inspection
– 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 appropriate for use (i.e., matching the sampling plan
to the criticality of the product and to the process
capability)
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9110:2009
Quality Management SystemsRequirements for Aviation and
Defense - Maintenance
Organizations
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9110 QMS Maintenance
9110 Overview
• Modeled after AS9100 Standard
• Includes nearly every aerospace-unique
requirement in AS9100, no clauses excluded
• Includes all basic “ISO” requirements in ISO
9001:2008
• Includes a few additional requirements unique to
Aerospace Maintenance Organizations
• Added Foreword which is similar to AS9100 but
tailored for maintenance, repair and overhaul
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9110 QMS Maintenance
Key Points
• There are two significant themes in 9110 and
they are:
– Safety
– Management Responsibility
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9110 QMS Maintenance
Key Points
• 9110 Safety additions (examples):
– 4.2.1.e General – “documented statements of a safety
policy and safety objectives”
– 5.1.f.g Management Commitment – “establishing the
safety policy”, and “ensuring that safety objectives are
established”
– 5.4.3 Safety Objectives – “Top management shall ensure
that safety objectives”
– 5.6.1 Management Review – General – “assessing
opportunities for improvement and the need for changes
to the safety policy and safety objectives”
– 5.7 Safety Policy
– 3.5, 8.5.3
- Human Factors
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9110 QMS Maintenance
Key Points
• 9110 Management additions (examples):
– 5.5.1.1 Accountable Executive Manager – “Top
management shall appoint a manager with corporate
authority”
– 5.5.1.2 Maintenance Manager(s) – “Top management
shall appoint a manager(s) responsible for assuring that
all maintenance required is carried out”
– 5.5.2.e Management Representative – “reporting to the
Accountable Executive Manager and Maintenance
Manager(s) on the performance of the quality
management system and any need for improvement”
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Deployment Support
http://www.iaqg.org
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Questions?