9100:2016 Transition Training Presentation for Auditor Workshop 21
9100:2016 Transition Training Presentation for Auditor Workshop 21 July 2016 The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region Key Talking Points IAQG Other Party Management Team Who are they? What do they do? Why is the training needed? What is the focus of the training? What will the training include? What is the training format, how long will it take and what will it cost? When will the training be available? How does this impact the 9100:2016 transition timeline? Current Program Timeline and Status 2 IAQG OPMT Structure: ++ IAQG-OPMT Chair + IAQG-OPMT VChair * Sector OPMT Leader IAFVoting Focal: Members Norbert Borzek DAkkS Brian Geer Lockheed Martin AB Focals: CB Focals: Ind. Assoc. & OASIS Focals: IAQG OPMT Ian Folland IAQG OPMT Support Bryan Blunt / Giuseppe Leoni OASIS Support Americas Asia Pacific
Europe R Darrell Taylor * Yoshifumi Yasunaga* Mark Rogers * Raytheon KHI Finmeccanica Helicopter Division Tim Lee Shuji Komori Marie-Laurence Petit+ Boeing FHI Susie Neal ++ Airbus Hubert Kern (Alternates) Tamaki Nishio IHI Li Runqi AVIC/CAPE FACC (Alternates) Andr LaCroix Airbus D&S Eric Saillard Thales Dale Gordon Kunihiro Tanabe Steve Randall Jeanette Preston Michihiko Banno Franois Dumesnil UTC Aerospace Systems (Alternates) John Horan Honeywell Judy Chapman Parker Brian Geer Lockheed Martin ANAB
Smithers Quality Assessments Becky Lemon SAE JAB UKAS BSK Bureau Veritas Certification Takayoshi Maehata Ian Folland SJAC Structure as of April 22, 2016 EAQG 3 IAQG Other Party Management Team 2016 Tactical Objectives IAQG Strategic Objective 1: Enhance the competency of Auditors, Other Party (OP) Assessors and stakeholders that are engaged in ICOP activities # Aligns with Hoshin Who? With? 1 - IAQG OPMT REQ 2 3 C1 - IAQG OPMT
REQ IAQG OPMT REQ Complete 2016 Tactical Objectives Status 9104-003 Revision: Submit 9104-003 standard for publication and prepare for transition December 31, 2016 Training Development: Work with the existing Training Development Partner to develop and implement required 9100:2016 series training within 6 months of the publication of all of the 9100:2016 and 9101:2016 in all 9 IAQG languages August 30, 2016. Training content to be enhanced to include guidance for auditing design and development and competence (skills and knowledge) of employees in the 9100:2016 series transition training (reference SCMH - QANPD). Publish the 9100/9110/9120/9101:2016 Supplemental Rule for AQMS transition within 1 month of the publication 9100:2016 series - July 31, 2016. On Plan The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region Off Plan (Recoverable) Off Plan (Not Recoverable) No Activity to Date 4 IAQG Other Party Management Team 2016 Tactical Objectives IAQG Strategic Objective 2: Continually improve the globally harmonized Industry Control Other Party quality management system certification program to be efficient, recognized, and communicate measurable benefits to stakeholders. # Aligns with Hoshin Who? With? 2016 Tactical Objectives 4
D2 IAQG OPMT REL OASIS: Implement and operationalize the Next Generation version of OASIS with Phase 1 implemented to support 9100:2016 series transition - October 2016 IAQG OPMT Operations: The IAQG OPMT develops, operates and maintains the Industry Controlled Other Party (ICOP) 9100/9110/9120 QMS certification scheme through December 2016 which includes ongoing activities to: Work with stakeholders to improve confidence in the ICOP scheme Hold conferences, workshops and continue communications to improve stakeholder awareness. Complete 100% of the 9104-002 required shared oversight 5 - IAQG OPMT - 6 G2 IAQG OPMT OMS 7 - IAQG OPMT REQ Complete Status Create IAQG MOU/Requirement for IAQG companies to use OASIS Feedback by the IAQG Miami Meeting in October 2016 ICOP Analysis: Conduct a Process Analysis on the ICOP certification process. Utilize the results of the analysis to identify 9104-001 changes needed, via a revision design specification and submit to the IAQG for approval for a 9104-001 revision initiative by December 31, 2016. On Plan The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region
Off Plan (Recoverable) Off Plan (Not Recoverable) No Activity to Date 5 Why is the training needed? Support Transition to 9100:2016 Series Standards 6 What is the focus of the training? Provide knowledge required for currently authenticated auditors to be able to effectively audit to the newly revised 9100:2016 series of standards. 9100:2016 Series Training Is Is Not Focused on the ASD specific requirement changes Focused on the ISO 9001 requirement changes Targeted at deltas or changes not the entire standard A training course which covers the entire standard Targeted at application and use of the 9101 forms and reporting A replacement for the Aerospace Auditor Transition Training (AATT) 7 What will the training include? The 9100:2016 module will include: ISO 9001 Pre-assessment 9100:2016 delta training and nonscored review with general feedback 9101:2016 delta training
9101:2016 Forms and Audit Reporting for 9100:2016 and scored assessment with general feedback Fail 9100:2016 Delta Training ISO 9001:2015 Pre-Assessment 9100:2016 Delta Comprehensive Review 9101:2016 Delta Training 9101:2016 Forms & Audit Reporting for 9100:2016 & Assessment Pass 80% Pass Fail 80 % 8 What will the training include? What do we mean by Delta? Generally: Are there Aviation, Space & Defense additions? Do the Aviation, Space and Defense additions reflect a change in intent? Does the ISO based change pose significant impact to the Aviation, Space and Defense clients? 9 What will the training include? Training Section Title 9100:2016 Relevant Clauses 3.1 Scope of the QMS and Consideration of Services 4.3
3.2 Clarifications and Improvements to Configuration Management 8.1.2 3.3 Operational Planning and Control includes Project Management and Work Transfer 8.1 3.4 Externally Provided Processes 8.4.1, 8.4.2, 8.4.3 3.5 Refactoring of Post Delivery Support Requirements 8.5.5 3.6 Auditing of Design and Development Processes 8.3.3, 8.3.4, 8.3.5, 8.3.6 4.1 Refactoring of risk-related requirements with emphasis on Risk in Operations 8.1.1, 8.2.2 4.2 Product Safety 8.1.3, 3.4 4.3 Counterfeit Parts 8.1.4, 3.1 5.1 Auditing of Competencies 7.2, 7.3 5.2
Expectations for quality system documented information 4.4 7.5.1, 22.214.171.124 6.1 Human Factor Considerations 10.2 7.1.4, 8.5.1 7.1 Other 9100-specific changes and refactored clauses 3.5, 5.3, 126.96.36.199, 8.2.3, 8.5.1, 8.6, 8.7, 9.3.2, 9.3.3 Indirect Mentions 188.8.131.52, 8.3.5, 8.3.6, 8.5.2 5.1.2, 8.1, 9.3.2, 9.3.3, 10.3 8.4.2, 8.4.3, 8.7.1 Adapted from Plexus International 9100 Content Review 10 What will the training include? ASD added content? ASD significant change in intent? Covered in detail in training? Clause Clause Title 1 Scope Yes No No 2
Normative References Yes No No 3.1 Counterfeit Parts Yes Yes Yes 3.2 Critical Items Yes No No 3.3 Key Characteristic Yes No No 3.4 Product Safety Yes Yes Yes 3.5 Special Requirements Yes No No 4.3
Determining the scope of the Quality Management System No No Yes Comments Scope of the QMS and Consideration of Services Adapted from Plexus International 9100 Content Review 11 What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? Comments 4.4 Quality Management System and its Processes Yes Yes Yes Expectations for quality system documented information 5.1.2 Customer Focus Yes
No No Risk-related addition covered in other training sections 5.3 Organizational Roles, Responsibilities, and Authorities Yes Refactored No This is restoring a requirement that was previously in ISO 9001; mentioned in other 9100specific changes and restructured clauses 6.1 Actions to Address Risks and Opportunities No Yes Yes Relates to changes in Clause 8.1.1 184.108.40.206 Measurement Traceability Yes Yes No Mentioned in other 9100specific changes and restructured clauses Adapted from Plexus International 9100 Content Review 12 What will the training include? ASD added
content? ASD significant change in intent? Covered in detail in training? Clause Clause Title 7.2 Competence Yes Yes Yes 7.3 Awareness Yes Yes Yes 7.4 Communication Yes No No 7.5.2 Creating and Updating Documented Information Yes No No 7.5.3 Control of Documented Information
Yes Yes Yes 8.1 Operational Planning and Control 8.1.1 Operational Risk Management Yes Yes Adapted from Plexus International 9100 Content Review Yes Yes Comments Yes Operational Planning and Control includes Project Management and Work Transfer"; also covered indirectly in other sections Yes Refactoring of risk-related requirements with emphasis on Risk in Operations 13 What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in
detail in training? Comments Clarifications and Improvements to Configuration Management 8.1.2 Configuration Management Yes Yes Yes 8.1.3 Product Safety Yes Yes Yes 8.1.4 Prevention of Counterfeit Parts Yes Yes Yes 8.2.2 Determining the Requirements for Products and Services Yes Yes Yes Refactoring of riskrelated requirements with emphasis on Risk in Operations" 8.2.3 Review of the Requirements for Products and Services
Yes Yes No Mentioned in "Other 9100-specific changes and restructured clauses" Adapted from Plexus International 9100 Content Review 14 What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? 8.3.3 Design and Development Inputs Yes Yes Yes 8.3.4 Design and Development Controls Yes Yes Yes 8.3.5 Design and Development Outputs Yes
Yes Yes 8.3.6 Design and Development Changes Yes Yes Yes 8.4.1 Control of Externally Provided Processes, Products and Services Yes Yes Yes 8.4.2 Type and Extent of Control Yes Yes Yes 8.4.3 Information for External Providers Yes Yes Yes Adapted from Plexus International 9100 Content Review Comments Auditing Design and Development processes", Special Emphasis by request of SWG 15
What will the training include? ASD added content? ASD significant change in intent? Covered in detail in training? Clause Clause Title 8.5.1 Control of Production and Service Provision Yes Refactoring No 220.127.116.11 Control of Equipment, Tools, and Software Programs Yes No No 18.104.22.168 Validation and Control of Special Processes Yes No No 22.214.171.124 Production Process Verification Yes No No
8.5.2 Identification & Traceability Yes No No 8.5.4 Preservation Yes No No Adapted from Plexus International 9100 Content Review Comments Addressed in other areas of the training Restored some requirements that were removed from 9001 in 9001:2015; Mentioned in other 9100-specific changes and restructured clauses" 16 What will the training include? ASD added content? ASD significant change in intent? Covered in detail in training? Clause Clause Title 8.5.5 Post-Delivery Support Yes
Yes Yes 8.6 Release of Products and Services Yes Refactoring No Mentioned in other 9100specific changes and restructured clauses" Counterfeit Parts; related to clause 8.1.4 and definition in clause 3.1; also mentioned in other 9100-specific changes and restructured clauses 8.7 Control of Nonconforming Outputs Yes Refactoring Yes 9.1.1 Monitoring, Measurement, Analysis, and Evaluation General Yes No No 9.1.2 Customer Satisfaction Yes No No 9.1.3
Analysis and Evaluation Yes No No Adapted from Plexus International 9100 Content Review Comments 17 What will the training include? Clause Clause Title 9.2 Internal Audit 9.3.2 Management Review Inputs ASD added content? Yes Yes ASD significant change in intent? No Yes Covered in detail in training? Comments No No Mentioned in other 9100specific changes and restructured clauses, Risk-related addition covered other portions of the training 9.3.3 Management Review
Outputs Yes No No Risk-related addition covered indirectly in training; also mentioned in other 9100-specific changes and restructured clauses 10.2 Nonconformity and Corrective Action Yes Yes Yes Address Human Factor concerns 10.3 Continual Improvement Yes No No Removal of Preventive Action covered in the Training Adapted from Plexus International 9100 Content Review 18 What will the training include? The 9110:2016 and 9120:2016 modules will include: 9110:2016 or 9120:2016 delta training and nonscored review with general Fail Pass feedback 9101:2016 Forms 9100:2016 Pass & Audit 9101:2016 to
Deltaany 9110 or 9120 9100:2016 Delta Delta 9101:2016 delta training specific specific considerations Reporting for 80% Training Training Comprehensive 9100:2016 Review and audit reporting considerations for 9110:2016 or 9101:2016 forms & Assessment 9120:2016 and scored assessment with general feedback Fail 91x0:2016 Delta Training 91x0:2016 Delta Comprehensive Review 9101:2016 Delta Training 9101:2016 Forms & Audit Reporting for 91x0:2016 & Assessment 80% 19 What is the format, duration & cost of the training? The following shows the format, duration and cost for the various modules, barring any unforeseen change: Module 9100 9110 9120 Format Content Duration
ISO 9001 Pre-assessment 9100:2016 delta training 9101:2016 delta training 9101:2016 forms and audit reporting Assessment 2 Hours 3 Hours 9110:2016 delta training 9101:2016 delta training (9110:2016) 9101:2016 forms and audit reporting Assessment 3 Hours Online Online 9120:2016 delta training 9101:2016 delta training (9120:2016) 9101:2016 forms and audit reporting Assessment Online Cost $545 US 4 Hours (9110:2016) 2 Hours $250 US 1.5 Hours (9120:2016) 1 Hours $250 US
20 What if I do not pass an assessment? Obviously our goal is to have auditors pass the assessments on the first pass. Participants may retake the pre-assessment or assessments as follows: Assessment Cost Retake Criteria ISO 9001:2015 Pre-Assessment $50 per attempt 1st retake attempt: minimum of 24 hours following the initial attempt 9100:2016 $195 per attempt 9110:2016 $125 per attempt 9120:2016 $125 per attempt 2nd retake attempt: minimum of 10 days following the 1st retake attempt 3rd Retake attempt: minimum of 30 days following the 2nd retake attempt General assessment feedback will be provided to participants 21 When will the training be available? Module Expected Standard Release Expected Training Availability 9100 9100 end of October 9101 end of November 30 November 2016 132
9110 9110 end of October 30 November 2016 132 9120 9120 end of December 10 January 2017 173 From 21 July 2016 22 Training Development Status as of 19 July 2016 The IAQG is a legally incorporated international not for profit association (INPA) with membership from the Americas, Europe and the Asia Pacific Region IAQG OPMT Tactical Objective 4-Square Objective Title: Tactical Objective #: Training Development C1 Date Initiated: 10 Aug 2015 TO Leader: John Horan Revision: 19 Jul 2016 Objective Description: Develop and deploy auditor training in support of the 9100:2016 series transition activities. Tasks and Deliverables: Develop and approve SOW (Proposal) and Amendment to existing PO for Training development activities. OPMT and Plexus ensure that the critical timing milestones are completed as defined in agreed upon proposal. Deliverables: Major deliverable is availability of 9100:2016 series training by agreed dates. Milestones defined in timing plan. (30 November for 9100 & 9110; 10 January for 9120) Current Status and Metrics: Status: Re-scoped for Plexus support of Standards translation activities Re-stated program timing based on standards availability, initial training feedback and instituting kick off interviews
with writing team reps.. Plexus proposed timing presented to OPMT team on June 2, 2016. Help Needed: Metrics: Milestone fidelity IAQG OMPT Tactical Objective 4-Square Resources: Plexus apply lessons learned and previous feedback to provide viable product per timing plan. OPMT/Industry Resources complete assigned tasks on time. Identified IDR and SDR support when Plexus requests feedback/guidance. Improved triage of feedback to give Plexus clearer direction. 24 9100:2016 Series Training Development Decisions Decisions: SWG direction in Singapore to have 3rd party assist with translation of standards to support training development. OPMT representatives in Singapore decided to have Plexus support this activity based on timing and need for linkage to training development. Plexus asked to proceed with three pricing alternatives. Prefer the IAQG pay additional cost of standards translations. (Auditors should not have to pay for an ineffective standards process). Sanctioned Training Team representatives discussed in a meeting on 23 May. Bill Schmiege agreed to have IAQG pay required standards translation costs 25 9100:2016 Series Training Development Decisions Decisions: OPMT & Plexus have agreed to initiate planning meetings with representatives of the standards writing teams for the purpose of ensuring the content and application of the standard are properly targeted and accurate for the auditor training. 13-17 June Planning Meeting with 9110 stakeholders Review meeting with 9100 & 9101 stakeholders 20-24 June Complete Complete Training development plan reformatted to reflect these changes. See following slides. 26
9100:2016 Series Training Development Timing 27 9100:2016 Series Training Development Timing 28 9100:2016 Series Training Development Timing Representative CB involvement 29 9100:2016 Series Training Development Timing Representative CB involvement 30 9100:2016 Series Training Development Translation Plan/Status (as of 18 July) Chinese STD Plexus 9100 9101 9101 Forms C STD Bodies STD Body Feedback C Plexus C STD Bodies STD Body Feedback I Plexus C STD
TRN German STD TRN Italian STD C C 3&6 June 3&6 June C C No Fdbk N/R C C awaiting receipt awaiting receipt N/R awaiting receipt STD Bodies STD Body Feedback TRN French I C TRN Japanese STD C
TRN Korean STD C TRN Portuguese STD C awaiting receipt C No Fdbk C C C C N/R 30 June No Fdbk No Fdbk C No Fdbk C C C C C awaiting receipt awaiting IAQG support C No Fdbk awaiting IAQG
support No Fdbk STD 30 May & 16 June awaiting receipt awaiting receipt TRN Spanish No Fdbk 30 June C No Fdbk Plexus 9110 STD Bodies 8 June awaiting receipt 18 July awaiting IAQG support STD Body Feedback Plexus 9120 STD Bodies STD Body Feedback 8 June July awaiting receipt 18-22
awaiting IAQG support July 18-22 Grayed cells will not be translated at this time due to lack of demand. 30 June 31 TRN 9100:2016 Series Training Development Translation Plan/Status (as of 18 July) Plexus Notes/Comments 9100:2016 Translation Review Status Chinese Complete OK to proceed. German Complete OK to proceed. French Complete OK to proceed. Italian In Process Japanese In Process Korean Complete (no reviewer assigned) Portuguese Complete (reviewer assigned,
no feedback) Spanish Complete No response back from authorized reviewer designated by IAQG, Gianluca Salerio. On 6/16, Paolo Santato responded back and stated that "on behalf of Mr. Salerio who is involved in a meeting abroad, I inform you that the standard has been forward to the relevant stakeholder in order to check the right translation." On 6/20, Paolo Santato requested that Plexus contact Piero Visconti ( [email protected]) to check status on translation review of 9100:2016 standard. REQUESTED ACTION: Plexus is requesting support from the IAQG to establish contact with an authorized reviewer who is available to support in the review/verification of standard translations prepared by Plexus. Plexus spoke with Hiroshi Shuto. Hiroshi will support as point of contact for coordination with SJAC. Plexus US/Japan will coordinate with Hiroshi to obtain 9100:2016 standard for use in training material. Plexus Requesting IAQG Assistance No reviewer assigned for Korean language. OK to proceed. No review feedback provided by Sandra Feliciano. Multiple requests to review Portuguese translations prepared by Plexus with no response. If Plexus is unable to obtain feedback from authorized reviewer designated by IAQG, Plexus will proceed using the high quality translations performed by Plexus translations team. REQUESTED ACTION: Plexus is requesting guidance from IAQG on the issues raised by Sandra. Plexus Requesting IAQG Assistance OK to proceed. 32 Other Considerations Impact of overall transition timeline and dependencies: Lessons learned related to OPMT/Plexus tie out on content. Improved triage of feedback comments and more precise direction to Plexus Drive greater level of IDR/SDR involvement in content. Drive a better deliverable. Incredibly tight timeline with no program slack. Virtually all resource timing has moved from original plan. All deliverables must be completed on time. 33 Next Steps
Communicate new program timing to IAQG volunteer resources and determine how to split assignments as required to ensure coverage. Establish Program status meetings every two weeks to keep program activities in front of us. Recent Deliverables: May 30 June 10 June 1 - 8 Translation Review: 9100 Standard (Stds Bodies) 63% Complete Review of new pre-assessment questions/scenarios Complete June 13 - 17 Planning meeting with 9110 stakeholders Complete June 20 - 24 Review Meeting with 9100 + 9101 stakeholders Complete June 20 - July 1 June 27 June 30 July 6 Translation Review: 9101 Standard & Forms (Stds Bodies) Review 9001 Pre-assessment disposition report Gate 3 Review: 9110/9120 25% Complete Complete Complete Upcoming July/August Deliverables
July 18-29 July 27 August 5 Gate 4 Pilot 9101 - 9100/9101/9110/9120 Delta August 1-12 Translation Review: 9120 Standard (Stds Bodies) August 17-24 Gate 3 Review: 9101 9100/9110/9120 Translation Review: 9110 Standard (Stds Bodies) 34 Questions 35
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