AS9100:2016 SERIES TRANSITION UPDATES

Transcription

1 AS9100:2016 SERIES TRANSITION UPDATES BUDDY CRESSIONNIE

2 Introductions Buddy 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

3 Discussion Topics Transition Implementation Timeline 9100 C-D Comparison Data 9100:2016 NCR Pareto Analysis Communications Deployment Support Materials FAQs Clarifications

4 AS9100:2016 Series Transition Implementation Timeline Sept 2015: ISO 9001:2015 released Sept/Oct 2016: AS9100:2016- Series released June 2017: All CB Audits to AS9100:2016 Series Sept 2018: Transition to AS9100:2016 Series Complete Standard Development QMS AS9100-Series Implementation AS9100:2016 Series Transition Activities AS9100-Series Standard Support Material QMS CB Transition Audits QMS transition is an excellent opportunity to ensure the QMS is effective and meeting expectations

5 AS9100D Comparisons and Trends Text Comparisons Rev C Rev D Leadership: Strategic 1 5 Accountability 1 12 total 2 Demonstrate total Promote 2 4 Preventive: 9100 Comparison Data Prevent Issues 1 28 total total Risk Opportunity 0 33

6 9100 Comparison Data AS9100D Comparisons and Trends Text Comparisons Rev C Rev D Process Approach: Process Output Monitor Effective total total Performance Intended Achieved Results Control

7 9100 Comparison Data AS9100D Comparisons and Trends Text Comparisons Rev C Rev D Compliance: Measure Validate 5 48 total 4 48 total Verify 5 8 Corrective: Action total total Change 31 53

8 :2016 NCR Pareto Analysis (63 Certs) Top 5 NCRs 8.4 Externally Provided Processes, Products, and Services Production & Service Provision 7.1 Resources (10 M&M Resources, 1 Infrastructure, 1 Org Knowledge) 7.5 Documented Information 4.4 QMS Processes (Most Majors) Major 15 Minor The 4.4 IAQG is 5.1 a legally 5.2 incorporated international 6.2 not 6.3for profit 7.1 association (INPA) 7.4 with membership from 8.2the Americas, Europe 8.5 and the 8.6Asia 8.7 Pacific Region 9.1 (Rev )

9 Requirements Communication Date 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 9

10 Requirements Communication Date 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 10

11 Requirements Communication Webinar # of Webinars # Attended (Approx.) 9100 Key Changes Clause-by-Clause Changes Changes Webinars on all certification standards (9100/9110/9120) have been recorded and posted on the IAQG website

12 9100 Series Communications & Support Material Newsletter Inputs Key Changes Presentation Correlation Matrix FAQ Clarifications Lead April 2015 Oct 2015 April 2016 Oct 2016 Buddy Brigitte Alan Kim Buddy Recurring Webinars IDR/ SDRs/Team SCMH partnering SCMH partnering SCMH partnering 12

13 Deployment Support Materials 1

14 Deployment Support Materials 2 IAQG Procedure paragraph requires the project team to: Develop and define the implementation strategy and plan, including deployment support material.

15 Deployment Support Materials

16 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

17 Frequently Asked Questions Questions 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)?

18 Frequently Asked Questions Questions 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)

19 Frequently Asked Questions Questions relating to specific clauses in the standard 11. Explain the intent of section 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)

20 Frequently Asked Questions Questions 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 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)

21 Clarifications IAQG 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 SDR names on IAQG Standards Register SDR will respond and publish when profound impact or significant dispute exist

22 Clause 4.2 Interested Party Clarifications 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?

23 Clause 4.3 Scope Applicability Clarifications 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

24 Clause 4.3 Scope Applicability Clarifications 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 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.

25 Clarifications Clause 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.

26 Clause 4.4 Process Measures Clarifications Clarification Request: Can the organization just have a top-level process to evaluate effectiveness of QMS processes? Clarification: No 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 valueadded. This is the measure that would be included in Process Effectiveness Assessment Report (PEAR) as the key performance indicator for that process.

27 Clarifications Clause 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.

28 Clause Counterfeit Parts Clarifications 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.

29 Clause External Provider Clarifications Clarification Request: What is meant by its external providers in clause 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.

30 Clarifications Clause 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?

31 Clause External Provider Clarifications 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)

32 Clarifications Clause 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.

33 Clarifications Clause Information for External Providers Clarification Request: The standard 9100:2009, clause requires that purchasing information shall identify purchased product including revision status of technical data. The standard 9100D, clause does not include this requirement. This information is no more required? Clarification: The clause requirement...identification of relevant technical data...would include the revision status.

34 Clarifications Clause 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.

35 Clarifications Clause Nonconformity and Corrective Action Clarification Request: Some are interpreting clause requirement that we are required to determine causes for EVERY nonconformity we encounter, no matter how insignificant. Clarification: Clause 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 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.

36 Thank You for your Participation and for Using Deployment Support Material!!!