9100:2016 Transition Training Presentation for Auditor Workshop 21 July 2016
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
Marie-Laurence Petit+ IAQG OPMT Structure: IAQG OPMT ++ IAQG-OPMT Chair + IAQG-OPMT V-Chair * Sector OPMT Leader Europe Mark Rogers * Finmeccanica Helicopter Division Marie-Laurence Petit+ Airbus Hubert Kern FACC (Alternates) André LaCroix Airbus D&S Eric Saillard Thales Asia Pacific Yoshifumi Yasunaga* KHI Shuji Komori FHI Tamaki Nishio IHI Li Runqi AVIC/CAPE Americas R Darrell Taylor * Raytheon Tim Lee Boeing Susie Neal ++ UTC Aerospace Systems John Horan Honeywell Judy Chapman Parker Brian Geer Lockheed Martin Voting Members Steve Randall UKAS Kunihiro Tanabe JAB Dale Gordon ANAB AB Focals: Ian Folland EAQG Becky Lemon SAE Takayoshi Maehata SJAC Ind. Assoc. & OASIS Focals: IAQG OPMT Support Bryan Blunt / Giuseppe Leoni OASIS Support François Dumesnil Bureau Veritas Certification Michihiko Banno BSK Jeanette Preston Smithers Quality Assessments CB Focals: Norbert Borzek DAkkS Brian Geer Lockheed Martin IAF Focal: Structure as of April 22, 2016
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? 2016 Tactical Objectives Status 1 - IAQG OPMT REQ 9104-003 Revision: Submit 9104-003 standard for publication and prepare for transition – December 31, 2016 2 C1 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). 3 Publish the 9100/9110/9120/9101:2016 Supplemental Rule for AQMS transition within 1 month of the publication 9100:2016 series - July 31, 2016. Complete On Plan Off Plan (Recoverable) Off Plan (Not Recoverable) No Activity to Date
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 Status 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 5 - 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 6 G2 OMS Create IAQG MOU/Requirement for IAQG companies to use OASIS Feedback by the IAQG Miami Meeting in October 2016 7 REQ 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. Complete On Plan Off Plan (Recoverable) Off Plan (Not Recoverable) No Activity to Date
Why is the training needed? Support Transition to 9100:2016 Series Standards
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)
What will the training include? The 9100:2016 module will include: ISO 9001 Pre-assessment 9100:2016 “delta” training and non–scored review with general feedback 9101:2016 “delta” training 9101:2016 Forms and Audit Reporting for 9100:2016 and scored assessment with general feedback ISO 9001 : 2015 Pre - Assessment 9100 2016 Delta Training Comprehensive Review 80 % Fail Pass 9101 Forms & Audit Reporting for
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?
What will the training include? Training Section Title 9100:2016 Relevant Clauses Indirect Mentions 3.1 Scope of the QMS and Consideration of Services 4.3 3.2 Clarifications and Improvements to Configuration Management 8.1.2 8.3.4.1, 8.3.5, 8.3.6, 8.5.2 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 5.1.2, 8.1, 9.3.2, 9.3.3, 10.3 4.2 Product Safety 8.1.3, 3.4 Counterfeit Parts 8.1.4, 3.1 8.4.2, 8.4.3, 8.7.1 5.1 Auditing of Competencies 7.2, 7.3 5.2 Expectations for quality system documented information 4.4 7.5.1, 8.5.1.1 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, 7.1.5.2, 8.2.3, 8.5.1, 8.6, 8.7, 9.3.2, 9.3.3 Adapted from Plexus International 9100 Content Review
What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? Comments 1 Scope Yes No 2 Normative References 3.1 Counterfeit Parts 3.2 Critical Items 3.3 Key Characteristic 3.4 Product Safety 3.5 Special Requirements 4.3 Determining the scope of the Quality Management System Scope of the QMS and Consideration of Services Adapted from Plexus International 9100 Content Review
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 it’s Processes Yes Expectations for quality system documented information 5.1.2 Customer Focus No Risk-related addition covered in other training sections 5.3 Organizational Roles, Responsibilities, and Authorities Refactored This is restoring a requirement that was previously in ISO 9001; mentioned in other 9100-specific changes and restructured clauses 6.1 Actions to Address Risks and Opportunities Relates to changes in Clause 8.1.1 7.1.5.2 Measurement Traceability Mentioned in other 9100-specific changes and restructured clauses Adapted from Plexus International 9100 Content Review
What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? Comments 7.2 Competence Yes 7.3 Awareness 7.4 Communication No 7.5.2 Creating and Updating Documented Information 7.5.3 Control of Documented Information 8.1 Operational Planning and Control Operational Planning and Control includes Project Management and Work Transfer"; also covered indirectly in other sections 8.1.1 Operational Risk Management Refactoring of risk-related requirements with emphasis on Risk in Operations Adapted from Plexus International 9100 Content Review
What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? Comments 8.1.2 Configuration Management Yes Clarifications and Improvements to 8.1.3 Product Safety 8.1.4 Prevention of Counterfeit Parts 8.2.2 Determining the Requirements for Products and Services Refactoring of risk-related requirements with emphasis on Risk in Operations" 8.2.3 Review of the Requirements for Products and Services No Mentioned in "Other 9100-specific changes and restructured clauses" Adapted from Plexus International 9100 Content Review
What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? Comments 8.3.3 Design and Development Inputs Yes Auditing Design and Development processes", Special Emphasis by request of SWG 8.3.4 Design and Development Controls 8.3.5 Design and Development Outputs 8.3.6 Design and Development Changes 8.4.1 Control of Externally Provided Processes, Products and Services 8.4.2 Type and Extent of Control 8.4.3 Information for External Providers Adapted from Plexus International 9100 Content Review
What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? Comments 8.5.1 Control of Production and Service Provision Yes Refactoring No Addressed in other areas of the training 8.5.1.1 Control of Equipment, Tools, and Software Programs 8.5.1.2 Validation and Control of Special Processes Restored some requirements that were removed from 9001 in 9001:2015; Mentioned in other 9100-specific changes and restructured clauses" 8.5.1.3 Production Process Verification 8.5.2 Identification & Traceability 8.5.4 Preservation Adapted from Plexus International 9100 Content Review
What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? Comments 8.5.5 Post-Delivery Support Yes 8.6 Release of Products and Services Refactoring No Mentioned in other 9100-specific changes and restructured clauses" 8.7 Control of Nonconforming Outputs Counterfeit Parts; related to clause 8.1.4 and definition in clause 3.1; also mentioned in other 9100-specific changes and restructured clauses 9.1.1 Monitoring, Measurement, Analysis, and Evaluation – General 9.1.2 Customer Satisfaction 9.1.3 Analysis and Evaluation Adapted from Plexus International 9100 Content Review
What will the training include? Clause Clause Title ASD added content? ASD significant change in intent? Covered in detail in training? Comments 9.2 Internal Audit Yes No 9.3.2 Management Review Inputs Mentioned in other 9100-specific changes and restructured clauses, Risk-related addition covered other portions of the training 9.3.3 Management Review Outputs Risk-related addition covered indirectly in training; also mentioned in other 9100-specific changes and restructured clauses 10.2 Nonconformity and Corrective Action Address Human Factor concerns 10.3 Continual Improvement Removal of Preventive Action covered in the Training Adapted from Plexus International 9100 Content Review
What will the training include? The 9110:2016 and 9120:2016 modules will include: 9110:2016 or 9120:2016 “delta” training and non–scored review with general feedback 9101:2016 “delta” training specific to any 9110 or 9120 specific considerations 9101:2016 forms and audit reporting considerations for 9110:2016 or 9120:2016 and scored assessment with general feedback
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 Format Content Duration Cost 9100 Online ISO 9001 Pre-assessment 9100:2016 “delta” training 9101:2016 “delta” training 9101:2016 forms and audit reporting Assessment 2 Hours 3 Hours 4 Hours $545 US 9110 9110:2016 “delta” training 9101:2016 “delta” training (9110:2016) 9101:2016 forms and audit reporting (9110:2016) $250 US 9120 9120:2016 “delta” training 9101:2016 “delta” training (9120:2016) 9101:2016 forms and audit reporting (9120:2016) 1.5 Hours 1 Hours
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 2nd retake attempt: minimum of 10 days following the 1st retake attempt 3rd Retake attempt: minimum of 30 days following the 2nd retake attempt 9100:2016 $195 per attempt 9110:2016 $125 per attempt 9120:2016 General assessment feedback will be provided to participants
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 9110 9110 – end of October 9120 9120 – end of December 10 January 2017 132 132 173 From 21 July 2016
Training Development – Status as of 19 July 2016
IAQG OPMT Tactical Objective 4-Square Objective Title: Training Development – C1 Tactical Objective #: 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. Metrics: Milestone fidelity Help Needed: 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.
9100:2016 Series Training Development 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
9100:2016 Series Training Development 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. Planning Meeting with 9110 stakeholders 13-17 June Review meeting with 9100 & 9101 stakeholders 20-24 June Training development plan reformatted to reflect these changes. See following slides. Complete Complete
9100:2016 Series Training Development Timing
9100:2016 Series Training Development Timing
9100:2016 Series Training Development Timing Representative CB involvement
9100:2016 Series Training Development Timing Representative CB involvement
9100:2016 Series Training Development Translation Plan/Status (as of 18 July) Chinese French German Italian Japanese Korean Portuguese Spanish STD TRN 9100 Plexus C STD Bodies 3 & 6 June awaiting receipt 30 May & 16 June STD Body Feedback No Fdbk 9101 N/R N/R awaiting receipt awaiting receipt 30 June I awaiting IAQG support 9101 Forms No Fdbk 9110 8 June 18 July awaiting IAQG support 9120 30 June Grayed cells will not be translated at this time due to lack of demand. July 18-22 July 18-22
9100:2016 Translation Review Status Plexus Notes/Comments 9100:2016 Series Training Development Translation Plan/Status (as of 18 July) 9100:2016 Translation Review Status Plexus Notes/Comments Chinese Complete OK to proceed. German French Italian In Process 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 (piero.visconti@finmeccanica.com) 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. Japanese 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. Korean (no reviewer assigned) No reviewer assigned for Korean language. OK to proceed. Portuguese (reviewer assigned, no feedback) 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. Spanish Plexus Requesting IAQG Assistance Plexus Requesting IAQG Assistance
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.
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 Translation Review: 9100 Standard (Stds Bodies) June 1 - 8 Review of new pre-assessment questions/scenarios June 13 - 17 Planning meeting with 9110 stakeholders June 20 - 24 Review Meeting with 9100 + 9101 stakeholders June 20 - July 1 Translation Review: 9101 Standard & Forms (Stds Bodies) June 27 Review 9001 Pre-assessment disposition report June 30 – July 6 Gate 3 Review: 9110/9120 Upcoming July/August Deliverables July 18-29 Translation Review: 9110 Standard (Stds Bodies) 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 63% Complete Complete Complete Complete 25% Complete Complete Complete
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