The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
AS9100:2016 SERIES TRANSITION UPDATES
BUDDY CRESSIONNIE
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
IntroductionsBuddy Cressionnie• Americas Aerospace Quality System Committee (AAQSC) Chair
• AAQSC Americas Leader of the IAQG “Requirements Strategy Stream” and AAQG Projects Chair (26 standards)
• AAQSC Americas 9100 Team Lead
• IAQG Liaison to Technical Advisory Group (TAG) to ISO/TC 176 participating on ISO 9001:2015 writing, ISO 9001:2015 interpretations, and ISO 9004 writing
• Probitas Aerospace Industry Experienced Auditor (9100/9110/9120)
• IRCA and Exemplar Global QMS and EMS Certified Lead Auditor
• Over 32 Years in AS&D Industry and Quality
Development, Training, Implementation, Auditing, and Feedback
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Discussion Topics
• Transition Implementation Timeline
• 9100 C-D Comparison Data
• 9100:2016 NCR Pareto Analysis
• Communications
• Deployment Support Materials– FAQs
– Clarifications
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
AS9100:2016 Series
Transition Implementation Timeline
Standard Development
QMS AS9100-Series Implementation
QMS CB Transition Audits
Sept 2015: ISO 9001:2015released
Sept/Oct 2016: AS9100:2016-Series released
June 2017: All CB Audits to AS9100:2016 Series
Sept 2018: Transition to AS9100:2016 Series Complete
AS9100-Series Standard Support Material
AS9100:2016 Series Transition Activities
QMS transition is an excellent opportunity to ensure the QMS is effective and meeting expectations
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
AS9100D Comparisons and Trends
Text Comparisons Rev C Rev D
Leadership: Strategic 1 5
Accountability 1 2
Demonstrate 8 11
Promote 2 4
Preventive: Prevent 15 27
Issues 1 11
Risk 12 86
Opportunity 0 33
12 total 22 total
28 total 157 total
9100 Comparison Data
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
AS9100D Comparisons and Trends
Text Comparisons Rev C Rev D
Process Approach:
Process 136 214
Output 16 36
Monitor 38 52
Effective 25 38
Performance 14 53
Intended 13 29
Achieved 14 33
Results 35 47
Control 69 108
360 total 610 total
9100 Comparison Data
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
AS9100D Comparisons and Trends
Text Comparisons Rev C Rev D
Compliance:
Measure 38 36
Validate 5 4
Verify 5 8
Corrective:
Action 75 109
Change 31 53
48 total 48 total
106 total 162 total
9100 Comparison Data
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015) 8
9100:2016 NCR Pareto Analysis (63 Certs)
0
5
10
15
20
25
30
4.1 4.2 4.3 4.4 5.1 5.2 5.3 6.1 6.2 6.3 7.1 7.2 7.3 7.4 7.5 8.1 8.2 8.3 8.4 8.5 8.6 8.7 9.1 9.2 9.3 10.1 10.2 10.3
Major
Minor
Top 5 NCRs8.4 – Externally Provided Processes, Products, and Services8.5 - Production & Service Provision7.1 – Resources (10 M&M Resources, 1 Infrastructure, 1 Org Knowledge)7.5 – Documented Information4.4 – QMS Processes (Most Majors)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015) 9
Requirements CommunicationDate Venue Activity
June 2016 Plexus Auditor Training Development
9100, 9101, 9110, and 9120 Team Engagement
July 2016 Quality Magazine Article AS9100:2016-Series Update
July 2016 RMC Auditor Workshop • 9100:2016 Clause-by Clause Presentation
• 9101:2016 Key Changes
August 2016 ASQ Quality Progress Magazine Article
Prepare for Landing: How to Get Ready for 9100:2016 Series of Standards
October 2016 Tokyo, Kobe, and Nagoya, Japan
APAQG JIS Q 9100:2016 Presentations
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015) 10
Requirements CommunicationDate Venue Activity
November 2016 International TC176 Meeting Communications, ISO 9001, and ISO 9004 Activities
November 2016 Israel Quality Conference 9100:2016 Workshop
March 2017 ASQ CQSDI Conference Clause-by-Clause Presentation
March 2017 NASA Quality Leadership Forum AS9100:2016 Implementation Risks
March 2017 International ISO Conference Workshop, Presentation, Panelist
May 2017 ASQ World Conference on Quality and Improvement
Good Processes for Great Products/Services that Take Off
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Requirements Communication
Webinar # of Webinars # Attended (Approx.)
9100 Key Changes 10 3300
9100 Clause-by-Clause 9 3400
9110 Changes 2 90
9120 Changes 2 500
Webinars on all certification standards (9100/9110/9120)
have been recorded and posted on the IAQG website
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015) 12
9100 Series Communications & Support Material
Lead April 2015 Oct 2015 April 2016 Oct2016
Recurring
Newsletter Inputs Buddy
Key Changes Presentation Brigitte
Correlation Matrix Alan
FAQ Kim
Clarifications Buddy
WebinarsIDR/
SDRs/Team SCMH partnering
SCMH partnering
SCMH partnering
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Deployment Support Materials
1
www.iaqg.org
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Deployment Support Materials2
www.iaqg.orgIAQG Procedure 105-1 paragraph 2.5.2 requires the project team to:
Develop and define the implementation strategy and plan, including deployment support material.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Deployment Support Materials
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Frequently Asked Questions
In developing this list of Frequently Asked Questions (FAQ's) for the 9100:2016 Series revisions, input has been obtained from experts and users of the standard from around the world. The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is intended that this list will also provide a good source of information for new users of the standards.
• Questions about the change
• Questions relating to specific clauses in the standard
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Frequently Asked QuestionsQuestions relating to specific clauses in the standard
1. What is meant by the context of the organization? (4)
2. What are the needs and expectations associated with interested parties? (4.2)
3. What are expectations relating to Human Factors?
4. What is meant by organizational knowledge? (7.1.6)
5. What is expected for Awareness (7.3)?
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Frequently Asked QuestionsQuestions relating to specific clauses in the standard
6. Documents and records have been replaced by documented information. What does this mean? (7.5)
7. Is there a guidance document or an ISO standard that I can obtain that defines a process for Risk Management (8.1.1)?
8. Is the product safety requirement applicable for all organizations? (8.1.3)
9. What are some methods to implement counterfeit part prevention? (8.1.4)
10. Why has Purchasing changed to ‘Control of externally provided processes, products and services’? (8.4)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Frequently Asked QuestionsQuestions relating to specific clauses in the standard
11. Explain the intent of section 8.4.3 m (a flow down requiring awareness of supplier personnel).
12. What has happened to validation of processes or what used to be called special processes? (8.5)
13. What is meant by post delivery activities and what is the extent of an organization’s responsibility? (8.5.5)
14. What are examples of documentation required for Release of Product? (8.6)
15. What is the difference in the standard between improvement and continual improvement? (10)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
Frequently Asked QuestionsQuestions relating to specific clauses in the standard
16. Why has Purchasing changed to ‘Control of externally provided processes, products and services’? (8.4)
17. Explain in detail the intent of section 8.4.3 m (a flow down requiring awareness of supplier personnel).
18. What has happened to validation of processes or what used to be called special processes? (8.5)
19. What is meant by post delivery activities and what is the extent of an organization’s responsibility? (8.5.5)
20. What are examples of documentation required for Release of Product? (8.6)
21. What is the difference in the standard between improvement and continual improvement? (10)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsIAQG Procedure 105.2, paragraph 3 Clarification Requirements
• Applies to all IAQG Standards
• Purpose to receive clarifications regarding requirements
• NOT intended to mediate disputes between organizations and
Certification Bodies (CBs)…Use CB Dispute Process!
• NOT intended for OASIS functionality issues…Use OASIS Help
Screens (Help Support – Contact Us)
• Clarification method of communication
o Next Gen OASIS
o E-mail – SDR names on IAQG Standards Register
• SDR will respond and publish when profound impact or
significant dispute exist
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 4.2 Interested Party
Clarification Request: Shall a third-party auditor issue an NCR if NOT
ALL relevant interested parties are identified?
Clarification:
• No requirement to consider interested parties that are not relevant.
• An acceptable practice is to use categories to group relevant
interested parties (i.e. customer, employees, external providers)
• What process did the organization use to identify and determine
relevance?
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 4.3 Scope Applicability
Clarification Request: Can a build-to-print sheet metal manufacturer
exclude clause 8.3 for tooling if they accept customer tool POs, design
tools, make tools, and deliver them to the customer?
Clarification:
• No, the tooling is considered a product since it is procured and
delivered to the customer.
• If the tooling is not contracted or sold to the customer, then the
development of tooling is an enabler to product build making of
tooling covered under clause 8.5.1d and 8.5.1.1.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 4.3 Scope Applicability
Clarification Request: The organization must develop and validate a
complex manufacturing process to achieve the results (special processes,
control software, automated measuring equipment). Are they required to
use design and development processes?
Clarification:No. 9100 requirements is for design and development of products and services, not of processes. An organization can use clause 8.3 for process development but it is not a requirement.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 4.4 QMS Processes
Clarification Request: Is it required that the control of nonconforming
outputs (Clause 8.7) process be measured and included in a Process
Effectiveness Assessment Report (PEAR)?
Clarification:
It depends. It is required that the control of nonconforming outputs
(clause 8.7) be monitored. It is up to the organization to determine if it’s
a top-level process that are measured and included on the PEAR. The
organization determines the sequence and interaction of QMS
processes. The standard requires monitoring, measurement where
applicable, and analysis of these QMS processes.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 4.4 Process Measures
Clarification Request: Can the organization just have a top-level
process to evaluate effectiveness of QMS processes?
Clarification:No. 9100 requires the organization to determine if the identified processes are effective and achieving planned results (see clause 4.4.1c). Each process measure should evaluate the effectiveness of that process and be value-added. This is the measure that would be included in Process Effectiveness Assessment Report (PEAR) as the key performance indicator for that process.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 7.1.5.2 Measurement Equipment Register
Clarification Request: Is it required that the register include the
equipment type, unique identification, location, and the calibration or
verification method, frequency, and acceptance criteria?
Clarification:• The requirement was not intended to force organizations to have the
register specifically include the "equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria.” The organization is required to have this information for equipment listed on the calibration register but not specifically in the register.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 8.1.4 Counterfeit Parts
Clarification Request: Can destroyed counterfeit parts be returned to the
supplier for credit?
Clarification:
• It depends. There is no issue returning counterfeit parts that are
made “unusable” for credit so long as there are no customer or
regulatory requirements prohibiting such a return.
• Those organizations that have contracts with the US Dept. of
Defense are prohibited from returning counterfeit electronic parts and
in some cases they (US DoD) may want those parts held in their
current “as received” state to be used for investigation and
potential prosecution.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 8.4.1 External Provider
Clarification Request: What is meant by “its external providers” in clause
8.4.1.1.b? Does this mean that an organization must maintain a register of
all its external providers or is a register of a limited subset sufficient?
Clarification:
The 9100 requirements in clause 8.4 are applied to the organizations
external providers that affect process, product, or service conformity. Type
and extent of control is based upon the scope of certification and supplier
impact on product conformity. If the organization wishes to apply a risk
management approach to suppliers indicating varying levels of rigor for
evaluation, approval, and re-evaluation dependent upon the
effect on product conformity…that is acceptable.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 8.4.1 External Provider
Clarification Request: What constitutes externally provided processes,
products, and services? Do we have to treat our sister sites as external
entities? Does this apply to all commodities?
Clarification:
• Combines the requirements from 9100:2009 Purchasing and Outsourcing.
• If processes, products, and services are coming from outside your defined
QMS and affect process, product, or service conformity; they are required
to be controlled in accordance with clause 8.4. This would include
external resources performing work on your premises. Annex A.8
provides some good guidance on this topic.
How far do we take this?
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 8.4.1 External Provider
Outsource (AS9100C): Where an organization chooses to outsource any
process that affects product conformity to requirements, the organization
shall ensure control over such processes. The type and extent of control to
be applied to these outsourced processes shall be defined within the quality
management system.
External Provider (ISO 9001:2015): External supplier, provider (3.2.5) that
is not part of the organization (3.2.1)
EXAMPLE Producer, distributor, retailer or vendor of a product (3.7.6) or a
service (3.7.7)
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 8.4.2 Type and Extent of Control
Clarification Request: Would you agree that we could be compliant to
9100:2016 without receiving or reviewing test reports for non-critical raw
material?
Clarification:
If your organization uses external provider test report to verify product
then your organization is required to have a process to evaluate the data
in these reports.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 8.4.3 Information for External Providers
Clarification Request: The standard 9100:2009, clause 7.4.2 requires
that purchasing information shall identify purchased product including
revision status of technical data. The standard 9100D, clause 8.4.3 does
not include this requirement. This information is no more required?
Clarification:
The clause 8.4.3 requirement...identification of relevant technical
data...would include the revision status.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 8.5.1.3 Production Process Verification (PPV)
Clarification Request: What was the intent of the writing team by adding…
The organization shall implement production process verification
activities to ensure the production process is able to produce
products that meet requirements.
Clarification:
It was introduced so all organizations, including those with small production
quantities, could apply PPV. The Team wanted to open the door for other
“process” methods to perform PPV that may be implemented to provide an
alternative methodology to the previously written PPV requirement.
Performing a FAI does not provide the warranty that the whole "production"
process will be able to product parts that meet requirements.
It was not the team's intent to mandate PPAP or process capability.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
ClarificationsClause 10.2.1 Nonconformity and Corrective Action
Clarification Request: Some are interpreting clause 10.2.1 requirement that we are required to determine causes for EVERY nonconformity we encounter, no matter how insignificant.
Clarification:Clause 10.2.1.b starts with "evaluate the need for action..." so the first action is to determine if there is a need for action. If so, then the following actions in clause 10.2.1.b would be required.
The organization establishes criteria for when corrective actions are appropriate to the effects of the nonconformities encountered. It is not wise to expend significant resources for isolated low-cost nonconformities.
The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region (Rev. 08-2015)
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