1. NEEDS & EXPECTATIONS: INTERESTED PARTIES TO ISO & AS9100
TRANSITION SUCCESS

2. Topics
Overall Patterns of NCs from the Certified Bodies’ (CB) Perspective
Feedback from Auditors
Audience Questions & Consultants’ Answers

3. WHAT CBs ARE SEEING
MOST PREVALENT TYPES OF NONCONFORMANCES

4. ISO 9001: 2015 NCR Pareto (ISO 9001Lessons Learned) Presented at ASQLA – APRIL 2017

5. ISO 9001: 2015 NCR Pareto (to midyear 2017)

6. ISO 9001:2015 Nonconformance Totals4 5 6 7 8 9 10
CONTEXT OF THE ORGANIZATION
LEADERSHIP
PLANNING
SUPPORT
OPERATIONS
PERFORMANCE EVALUATION
IMPROVEMENT
TOTAL
MINORS – 673
MAJORS – 35 68 17 57
205
175
139 47
708

7. MOST PREVALENT NCs THIS YEAR

8. …So What’s the Issue with Section 7 ? (Resources)
The new requirements in this section are #NCS
“organizational knowledge”
communication of responsibilities for
product quality, product safety, & ethical
behavior

9. …So What’s the Issue with Section 7 ? (Resources)
CB’s Most Common Findings # NC
7.5 Control of Documented Information
7.1.5 M&M Equipment
7.2 Competence
This Photo by Unknown Author is licensed under CC BY-SA

10. Unauthorized Changes to Documents
Out of Calibration Tools
Wrong Revision of Forms in Use
No Evidence of Competence
Evaluation
Unauthorized Changes to Documents
Out of Calibration Tools
Measuring Tool Not Recorded on Inspection Report
No Training Records
When new procedure is released
New Equipment introduced
Uncontrolled Document in Use

11. DO YOU KNOW WHAT TO DO ABOUT THESE PROBLEMS?
Q&A

12. Section 8 - Operations 8.1 Operational Planning & Control
This is serious
Determining requirements
Establishing criteria for 1. processes acceptance of products/services
Determining resources
Establishing control
Determining, maintaining, & retaining documented information
Determining processes & controls needed to manage critical items
Engaging representatives for ..planning & control
Determining processes/resources to support use & maintenance
Determining products & services to be obtained from external sources
Establishing controls ..to prevent delivery of nonconforming products
8.1.1 Operational Risk Management
8.1.2 Configuration Management
8.1.3 Product Safety
8.1.4 Prevention of Counterfeit Parts

13. No process: Who, What, When, How Process not implemented
8.1.1 Operational Risk Management
8.1.2 Configuration Management
8.1.3 Product Safety
8.1.4 Prevention of Counterfeit Parts
No process: Who, What, When, How
Process not implemented
No evidence of follow-through

14. RELATIONSHIP BETWEEN SPECIAL REQUIREMENTS & RISK MANAGEMENT

15. Section 9 – Performance Evaluation
CB’s Most Common Findings
# NC
Internal Audits
Mgt Review Inputs
Mgt Review

17. Internal Audits
Not performed to 2015 or Rev. D requirements
Management Review
2015 or Rev. D “Inputs” not reviewed
Mgt. Review Not performed
Effectiveness of actions to address risk & opportunities not discussed

18. DO YOU KNOW WHAT TO DO ABOUT THESE PROBLEMS?
Q&A

19. Feedback from the Auditors
This Photo by Unknown Author is licensed under CC BY-NC-ND

20. Most Prevalent Findings
Objective Evidence for risk identification, assignment, management (6.1 & 8.1.1)
Ethics training (7.3)
Flow down to suppliers (8.4.3 m): ensuring that persons are aware of
Process to evaluate data in (material) test reports to confirm that product meets requirements (8.4.3)
Out-of-calibration personal equipment, unidentified equipment

21. REMARKS FROM AUDITORS
1         Make sure that they have completed their internal audit based on the ISO9001: Requirements and the audit records indicate that the new requirements are clearly identified. Risks, organizational knowledge, the additional requirements for analysis and evaluation

22. REMARKS FROM AUDITORS
2        The management review needs to also be completed and the records need to indicate that all the additional inputs and outputs are documented, particularly the action to mitigate risks.

23. REMARKS FROM AUDITORS
3. Lack of  evidenced for the new requirements in the internal audit and management review. Lack of KPI  for key processes, sales, engineering, purchasing processes.

24. REMARKS FROM AUDITORS
4. Make sure contracts are reviewed thoroughly and & there is evidence that customer requirements are flowed or implemented. (Example: requirements for annual audit to the customer’s ASQR or notification of changes to the status of the QMS within an established timeframe)

25. 5. Continuing lapses in control of M&M equipment – should be so easy to control; same thing with documentation
6. Some positive aspects – Customer communications (Good Evidence)
We like reviewing the evidence electronically
People seem to know more about how the whole organization operates
REMARKS FROM AUDITORS

26. Auditors are Requested to Verify in Transition Audits
AS9100 Rev. D
Product Safety Management
Counterfeit/suspected unapproved parts prevention
Installation of approved parts
Continuing airworthiness management
Evaluation of new capability
Risk management
Awareness (quality, product safety, ethical behavior)
Post delivery support
AS9120 Rev. B
Product safety
Counterfeit parts prevention
Risk management
Human factors
Configuration management
Post delivery support

27. How to Implement New Requirements

28. 4.1 Context of the Organization
THE REQUIREMENT-…determine external & internal issues to its purpose and strategic direction…that affect it’s ability to achieve the intended results
GUIDANCE
Talk with the top manager at your location
ASK: WHAT DOES THIS MEAN TO YOU?
LISTEN!
THINK! – What does this mean to the quality program?
DISCUSS: HOW CAN THE QUALITY PROGRAM SUPPORT THE ORGANIZATION’S GOALS
DEVELOP : ACTION ITEMS
4.1 Context of the Organization

29. 4.2 Needs & Expectations of Interested Parties
THE REQUIREMENT-…determine the interested parties…the requirements of the interested parties
GUIDANCE
ASK – Who are the “interested parties”…aka stakeholders?
What would you like to happen for these “interested parties”?
Who should address this?
How will we know if we are successful?
How can the Quality Department support this effort?

30. 7.1.6 Organizational Knowledge
THE REQUIREMENT - …determine the knowledge necessary for the operation …& achieve conformity of products & services
GUIDANCE
ASK:
What are you most concerned about the knowledge and information we need to work together effectively?
Where do you see the biggest deficits?
How….WHO… WHAT CAN WE DO?

31. 7.5 Documented Information
What documented information is REQUIRED?
What are effective formats for documented information?
What are effective methods for controlling documented information?
What protection processes are required for electronic information?
7.5 Documented Information

32. 8.1.3 Product Safety
What does this mean in the context of your business?
Assessment of hazards & management of …risks
Management of safety critical items
Analysis & reporting of occurred events affecting safety
Communication of these events & training of persons

33. 8.5.1 g Implementation of Actions to Prevent Human Error
Who has examples of error proofing?

34. 8.4.3 Control of External Processes
AS9100 Rev. D (New Requirements)
Must flow down d External provider’s interactions with organization
Must flow down e Control & monitoring of external providers’ performance
Must flow down k Prevent use of counterfeit parts
Must flow down m Ensure persons are aware of
Contributions to product/service conformity
Contribution to product safety
Importance of ethical behavior
SUGGESTION #1: Add to purchase orders:
Processes for counterfeit prevention, product safety, product quality, and ethical behavior are required of all YOUR COMPANY’S NAME HERE suppliers.  All applicable quality clauses on this order must be flowed to external sources used in this order.  Please note that on time delivery and quality performance is monitored.

35. RESPONDING TO NCs Audit reports are provided through OASIS
PEARS
NCRs

36. 24
Organization to enter the associated cause code from the IAQG listing as shown in Form 4 Annex A.
NOTE: Cause codes are used for IAQG data collection purposes only.

37. Use when uploading Root Cause to OASIS

38. Summary & Take-Aways

39. Summary & Take-Aways

40. Thank You!
To go from opinion to perception, from imagination to fact, from illusion to reality, from something that is not there to something that is, that is the way forward.
Svami Prajnanpad