as9100:2016 series transition updatesthe iaqg is a legally incorporated international not for profit...

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


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


Discussion Topics

• Transition Implementation Timeline

• 9100 C-D Comparison Data

• 9100:2016 NCR Pareto Analysis

• Communications

• Deployment Support Materials– FAQs

– Clarifications


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


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




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





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


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)


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


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


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


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


Deployment Support Materials

1

www.iaqg.org


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.


Deployment Support Materials


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


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)?



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)



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)



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)


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


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?


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.


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.


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.


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.


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.


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.


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.



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?



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)


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.


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.


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.


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.


Thank You for your Participation

and for

Using Deployment Support Material!!!