Transcript NATIONAL QUALITY ASSURANCE

6th Annual ‘Anti Counterfeiting Forum’ Seminar
Anti Counterfeiting Standards
&
Accreditation Services
Development
Kevin Beard
President – NQA
February 19, 2015
Audience Check-In
• How Many Companies Certified to
AS9100/AS9120/ISO 9001?
• How Many Companies have Contractual Flow Downs
for AS5553 or AS 6081?
– Or Other CPP Requirements?
• How Many Organization’s Currently Have A CPP
Program?
– And are Auditing within their AS9100/AS9120/ISO9001
Certification?
Presentation Focus
• Who is NQA
• Update on Accreditation
• Update of 5553/6081Revision Impacts
• Update on 9100 & 9120 Revision Impacts
• Industry Information Resources
Introductions- Who Is NQA
• Leading International Accredited
Certification Body
• Leading Aerospace Industry Registrar
• Serving Customers for Industry Success
• More than 30,000 Customers Worldwide
• AS9100
• AS9110
• AS9120
• AS5553
• AS6081
• ISO 9001
• ISO 14001
• TS 16949
• TL9000
• ISO 13485
• ISO 27001
• ISO 20000
• ISO 28000
• OHSAS 18001
• ESD S20.20
• Local audit resources world-wide
• Boeing
• NASA
• ESA
• Lockheed Martin
• Raytheon
• L-3 Communications
• Ball Aerospace
• United Launch Alliance
• AAQSC Voting Member
• AAQG/IAQG – Numerous Working Groups
• SAE G-19 Counterfeit Part Prevention WG
• QuEST Forum Member
• Automotive – IATF/SMMT
• Dept. of Homeland Security – Business
Continuity
Update On Accreditation & Certification
• Accredited Certification has Been Around for Decades
• Accredited Certification Schemes Are Understood and
Used by Government, Industry and Associated Supply
Chains
– Also Understood by Many Members of SAE G-19
• Initial Focus has Been on Requirements Standards for
Manufacturers, Distributors and Test Organizations
• Awaiting Efforts on Certification Integrity Focus
– In the Mean Time, …….…….
– NQA is Progressing Accredited Certification
Counterfeit Parts & The Industry
Model
MOD, ESA/NASA, Civil Aviation, Etc.
Primes
Primes
Emerging
Certification
Schemes
Not Design Resp
Sub-System
Component
Sub-Component
Parts OCMs
&
Aftermarket
Franchised
Distributor
Other Type
Distributor
•Stocking
•Broker
•Independent
AS 9120, AS 5553, AS 6081
Counterfeit Parts Entering the Supply Chain
Other
Sources
•Surplus
•Open Market
•Recyclers
•Etc.
AS 9100 & AS 5553
Primes
Design Resp
Industry Supply
Chain
NQA Focus for Accredited Certification
Services
• Alignment to IAQG (& Sector) Model
– Focus on End User/Government Control Model
– Focus on ISO 17021/17025 Based Model
• Continue with G-19 Supplement/Augmentation Approach
– Areas of Focus
• Standards, Competencies, Tools, Formants, Oversight Alignment, etc.
• Why is this Important
– Need Regulatory Compliance Aligned Approach
– Industry, End User, Authority/Government Recognition
– Supply Chain Efficiency & Cost Control
• Avoid Developing an Additional Industry Controlled Model (IAQG,
NADCAP, Etc.)
• Awaiting G-19 to Address & Achieve Alignment
• NQA Aligning Certification with Using IAQG & ANAB
Recognized Approaches
Accreditation & Certification Approach
Base Standard
Focus
Aerospace/G-14
G-19
Augmentation & Augmentation &
Oversight
Focus
Regulatory,
Authority,
Government
Compliance
Gov. Laws, Policies,
Contractual
Requirements and
other legal influences
Industry Control
• Standards Approval
• Auditor Approval
• AB/CB Approval, Etc.
IAQG (EAQG, AAQG,
APAQG)
Requirements
Standards for
Certified Company
ISO 9001
Company Requirements
AS9100
AS9110
AS9120
Certification
Integrity
Industry Oversight
N/A
NQA G/14 Aligned
Augmentation
•Aligned to IAQG format
•ANAB AR 36
•Awaiting G-19 augmentation
•AS5553
---
•AS6081
AS9104/1 &/2
N/A
•Awaiting G-19 augmentation
CB Oversight
AS9104/1 &/2
N/A
•ANAB AR36
CB Integrity Processes
• Industry Confidence
• Independence
• COI Avoidance
• Transparency
AS9104/1 &/2
N/A
•Aligned to IAQG format
•ANAB AR 36
•Awaiting G-19 augmentation
•Stage I/II/Surv/Reassess, etc
•Process, Duration, Frequency
•Certificate Reqts
•Effectiveness Determination
•NC Remedial Actions
AS9104/1
N/A
AS9101
N/A
ISO 17021
Competency
•Auditor – Experience, Testing,
Approvals
•Technical Reviews
•Etc.
AS9104/1 &/3
N/A
•Reporting
•Tools & Formats
•Cert Achieve Representation
AS 9101
AS 9101
OASIS Database
ISO 17021
Accreditation
Approach
ISO 17021
Audit Approach
N/A
N/A
•AS6463 & AS6301
N/A
N/A
•Aligned to IAQG format
•ANAB AR 36
•Awaiting G-19 augmentation
•ANAB AR36
•Awaiting G-19 augmentation
--•AS9101 Alignment
•OASIS Alignment
Update AS 5553/AS 6081
• AS6081
– Key Changes
• Test Requirements Removed (Pointer to AS6171 Added)
• Modified Competency Needs (Removed Reference to NAS 410)
• Strengthened Government Reporting (GIDEP, Etc.)
• Strengthened Supplier Selection (Risk Characterization)
– Ballot Deferred Until Completion of AS6171 Series
• AS5553
– Key Change - Appendices Removed
– AS5553b Ballot Failed
– Ballot Comments Being Worked
Update ISO 9001/AS 9100/AS 9120
- Foundations for AS5553/AS6081 -
Support From Other Standards & Upcoming Revisions
• ISO 9001:2008
– Currently Very General and Non CPP Specific
• Statutory/Regulatory
• Customer Requirements
• etc.
• ISO 9001:2015 Drafts
– Step Forward With Foundational Wording
– But Still No CPP Specific
• Risk
• Mitigation/Prevention
• Planning & Control
ISO 9001:2015 & Risk
Cust, Stat, Reg Requirements
Customer Focus
Design
8.3.2/8.3.3/8.3.6
8.4.2
Control of Ext. Suppliers
Ops Plan/Control
8.1
8.5.5
8.7
Ops Planning & Control
Post Delivery Plan/Cont
NC Control
4.4
7.5.1
9.2.2
9.3.1
10.1
10.2.1
QMS Processes
Documented Information
Internal Audits
Management Review
Improvement
NC & CA
QMS Processes
X
X
X
X
X
Planning, Input & Changes
External Providers
X
Control
4.2
5.1.2
Customer
X
Prevent
Mitigate
QMS Plan, Control & Changes
Conseqnce
6.1/6.1.2/6.3
Likelihood
QMS Plan/Change
Impact
Topic
Complex
DIS Ref.
Risk
Subject
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Current & Future Wording AS 9100/AS 9120
- Foundations for AS5553/AS6081 -
• Current AS9100
– Stronger Wording More Aligned to CPP Processes
• Risk, Special Requirements/Critical Items/Key Characteristics
• Supplier Risk Management
• Augmented Traceability & Inspection Wording
• Future AS9100
(draft)
– Requirements for Counterfeit Prevention Processes
• Training, Obsolescence, Traceability, Inspection, Reporting,
Quarantine
– Enhanced Wording on Key QMS Processes Supporting CPP
• Risk Based Purchasing Controls
– Supplier & Sub-Tier Supplier Controls
• Risk Based Inspection & Test
• Scrap of Validated Counterfeit items
Update AS 9100/AS 9120
Addressing Emergent Supply Chain Challenges
• Expanded Expectations & Needs in the Supply Chain
• Driving the Need For More Controls Deeper in the Supply
Chain
• IAQG Development of New Quality/Process Control Methods
• Changes to QMS Standards (AS9100, etc.)
• Risk & Escape Prevention
• Counterfeit Parts
• Sub-tier Supplier Control
• Raw Material Testing
• Obsolescence Management
Counterfeit
Parts
Raw
Material
Testing
• Notification of Change
• Compliance, Ethics, Safety Impacting Product
Risk Based
Controls
Emerging
Areas of
Focus
IT
Security
CM Focus Digital
Media
Sub-Tier
Other
Risk Associated Wording 9100 WD1
8.4.1
8.4.2
8.4.3
Ext. Providers General
Type & Extent of Control
Doc Info For Ext. Providers
+
+
8.1
8.1.1
8.1.2
8.1.3
Ops Planning & Control
Operation Risk Management
Configuration Management
Product Safety
+
+
8.5.1
8.5.2
8.5.4
8.5.5
8.5.6
8.7
QMS Processes
4.4
7.5.1/7.5.3.2
9.1.3
9.2.2
9.3.1
10.1
10.2.1
Control Production Provision
ID & Traceability
Preservation
Post Delivery Plan/Cont
Control of Changes
NC Control
QMS Processes
Documented Information
Analysis & Evaluation
Internal Audits
Management Review
Improvement
NC & CA
X
X
X
+
Planning, Input & Changes
D&D Control (review)
Counterfeit Parts
X
X
8.3.2/8.3.3/8.3.6
8.3.4
8.1.4
X
Control
Cust, Stat, Reg Requirements
Customer Focus
Determination of Requirements
Prevent
Mitigate
Ops Plan/Control
4.2
5.1.2
8.2.2.d
X+
Conseqnce
Severity
External Providers
QMS Plan, Control & Changes
Likelihood
Design
6.1/6.1.2/6.3
Impact
Customer
Topic
Complex
QMS Plan/Change
DIS Ref.
Risk
Subject
X
X
X+
X+
+
X
+
X
+
+
+
+
X+
+
+
+
+
+
X
X+
X
X
X
+
+
X
+
X
X+
+
X+
+
+
+
X+
+
X
X+
X+
X+
X
X
X
X
X
Information & Guidance for Supply Chain
New SCMH structure and content
3
Market
1
& Sell
• Master
Scheduling
2
Make (incl. Assemble & test)
• 9103 Material for Key
Characteristics
• Control of non
conformities
• 9102 Material for First
Article Inspection
• Foreign Object Debris
(FOD)
• Counterfeit & Suspect
Unapproved Parts
• Human factors for new
manufacturing
• TBD
5
Design & Develop
Deliver
• Delivery Metrics Definition
• Special Requirements & Critical Items
C
U
S
T
O
M
E
R
Customer
6 Support
• Statistical Process
Acceptance
• Certificate of Conformance
• Quality Aspects of New Product Development
• Delegated Product Release
verification
• Notification of Change
• Software Guidance (9115)
Appendices
• 9100 Rev C Deployment Support
Buy
4
• People Capability PCAP 001
• Supplier Selection and Capability
Assessment
• Link to ICOP Overview
• 9100/SSCA/PPDAC Comparison
• Product Performance Detailed
Assessment Checklists
• IAQG dictionary
• Supplier Quality Mgt Basics
• Sub-tier Supplier Control Management
Plan & Manage
7
•
• Work Transfer
• Root Cause Analysis & Problem
Solving
•
Advanced Product Quality Planning • Configuration management
(APQP)
• Capacity Management, Ordering and
Risk Management
Logistics
• Process Mapping (VSM Based)
8
Page 18
Stakeholders relationship and communication
• Requirements & Flow Down Templates
• Contractual Requirements Review & Management Guidance
Sections already in progress
Future sections
CC
UU
SS
TT
OO
MM
EE
RR
In Closing
Counterfeit Part Avoidance
• Significant Challenges Need Broad-based Solutions
• Industry Focus Ramping Up.
– Educational Information Available to Supply Chain
– Numerous Committees Are Working Towards Solutions
– Standards Are Evolving
– Accredited Certification is Available
• What Part will We Play in Solving this Industry
Problem?
• Accredited Certification is a Key Component of
Building Industry Trust!
Questions?
DOD, NASA, Civil Aviation, Etc.
Primes
Primes
Counterfeit
Part
Prevention
Sub-System
Component
AS 9100 & AS 5553
Primes
Sub-Component
Parts OEMs
&
Aftermarket
Franchised
Distributor
Other Type
Distributor
•Stocking
•Broker
•Independent
AS 9120, AS 5553, AS 6081
Other
Sources
•Surplus
•Open Market
•Recyclers
•Etc.
Overview
•
8.1.4
–
•
8.4.2 Type and extent of control of external provision
– Verification of externally provided products and services shall be performed according to the risks
–
•
•
Prevention of counterfeit parts
The organization shall establish, implement and maintain a process, appropriate to the product, that
prevents the use of counterfeit or suspect counterfeit parts and their inclusion in product(s) delivered
to the customer.
• NOTE
Counterfeit parts prevention processes should consider:
• training of appropriate personnel in the awareness and prevention of counterfeit parts;
• application of a parts obsolescence monitoring program;
• procurement requirements for assuring traceability of parts and components to their original
authorized manufacturers;
• inspection processes to detect counterfeit parts;
• monitoring of counterfeit parts reporting services;
• quarantine and reporting of suspect or detected counterfeit parts.
identified.
Verification activities shall include inspection of products or periodic testing, as applicable, where
there is high risk of counterfeit or nonconforming product.
8.4.3 Documented information for external providers
– The organization shall communicate to external providers applicable requirements for the following:
– j) requirements regarding the need for the external provider to:
– prevent the use of counterfeit products;
8.7
Control of nonconforming process outputs, products and services
– Product identified as counterfeit shall not be returned to the external provider and shall be controlled
and disposed of as scrap.
–
X