How to manage the transition successfully AEROSPACE & DEFENSE MANAGEMENT SYSTEM TRANSITION ON AS 9100 SERIES STANDARDS TECHNICAL GUIDE

Transcription

1 How to manage the transition successfully AEROSPACE & DEFENSE MANAGEMENT SYSTEM TRANSITION ON AS 9100 SERIES STANDARDS TECHNICAL GUIDE Move Forward with Confidence EDITION OCT 2017

2 IAQG HAS PUBLISHED THE NEW VERSION OF AEROSPACE AND DEFENCE STANDARD AS9100 SERIES END OF This version will replace current AS9100 : 2009 version standard series AS9100:2016 upgrade is based on ISO 9001:2015 version on which aerospace and defense requirements have been upgraded since previous version. The new standard is released keeping in mind the Aerospace industry actors need to adapt continuously to dynamic environment which requests efficiency and adaptability. This technical guide written by Bureau Veritas Aerospace experts will help you to prepare AS9100:2016 & ISO 9001:2015 Main changes 3 AS 9100:2016 & ISO9001:2015 MAIN 4 AQG 9100 D/2016 ISO 9001:2015 NEWS :2016 NEW REQUIREMENTS 9 What is the Transition Process? 10 How can Bureau Veritas Support you in Your Transition? 11

3 3 AEROSPACE STANDARD TRANSITION AS9100 SERIES AS9100: 2016 & ISO 9001:2015 MAIN CHANGES AS9100:2016 will follow ISO 9001:2015 document structure with the following clauses organization: 10 clauses instead of 8 on previous versions 1 to 3 : Generic and introductory clauses information s Introductory clauses SCOPE NORMATIVE REFERENCES TERMS AND DEFINITIONS 4 to 10: s replaces previous ones. These will allow to follow the PDCA cycle in coherence with High Level Structure process management Organization will have to satisfy all the new requirements during transition audit resulting from both Aerospace and ISO 9001 standard upgrade Basic clauses, common to all management systems standards CONTEXT OF THE ORGANIZATION LEADERSHIP PLANNING SUPPORT OPERATION 9 PERFORMANCE EVALUATION 10 IMPROVEMENT AS9100:2016 based on ISO 9001:2015 high-level structure and continuous improvement approach ISO 9001 : 2015 has developed its clauses structure based on the PDCA approach. This methodology is well known in the Aerospace industry and coherent with the increasing of continuous improvement requirement and expectations. IAQG complemented ISO approach with most recent requirements from Aerospace market and supply chain stakeholders. Note: The new high level structure has been clearly defined in this revision of the standard, for management to drive the organization towards having a robust management system fulfilling customer expectations as a whole. s ISO 9001:2015 & AS91XX Standard New Requirements PLAN 4 5 Context of organization Leadership 6 7 Planning Support Product Safety Prevention against counterfeited parts 8 Risk Management DO Operations Change Management Human factors Awareness CHECK 9 Performance Evaluation Monitor & measure the results Ethical Behavior Performance Evaluation Indicator. ACT 10 Improvement Take actions and improve the results The organizations are free to interpret the model as it sees fit to their management systems. It s not specifically requested to organize their MS along the same line than clauses. The Organization, the Quality Management System (QMS) documentation and processes need to be focused on the business needs and customer expectations.

4 AEROSPACE STANDARD TRANSITION AS9100 SERIES 4 AS 9100:2016 & ISO9001:2015 MAIN CHANGES New standard ISO9001:2015, have taken into consideration the changes occurred during the last decade in the industry. The management system within organization need to show more maturity in handling events whatever they are expected or not. For that, new ISO9001 insists a lot on the risk management to be applied on all the processes within the organization. ISO9001 clearly defined what s expected in the entirety of management system making sure the customer requirements and business performance are both satisfied in an efficient manner by product and/ or services delivered. Principle How to manage Documentation requirement Document only useful for processes efficiency oriented to core business satisfaction Specific documented procedure are not mentioned but only documented information Any document can be documented information Performance evaluation & Management Review Evaluate Quality Management System performance PDCA approach lead to the Management Review be the QMS performance evaluation Management Review will be C gate from PDCA in order to define A step and related action plan (if necessary) Planning & Risk Organizations need to address risks & opportunities by defining proper quality objectives & manage planning of changes Organization need to be get more flexibility and adaptability in front of unexpected changes Risk analysis approach will help to organization to be more robust Product & Service Make the organization think outside of the box. It s not only manufacturing process approach but all the industries services No Major impact since 2009 version as already mentioned. Due to the context evolution since v2009, it s clearly mentioned

5 5 AEROSPACE STANDARD TRANSITION AS9100 SERIES AS 9100:2016 & ISO 9001:2015 MAIN CHANGES RISK BASED THINKING Organizations are nowadays continuously asked to adapt to various unexpected changes. Based on ISO 9001:2015, AS9100:2016 standard focus on the adaptability and anticipation of risks in Automotive actors processes. It s now a pro-active approach that is requested. Organizations will have to analyze all the potential risks that the entire supply chain could face and define the necessary action plans and processes adaptation, that will be necessary in order to ensure the product and process reliability, while keeping in mind client requirements satisfaction. Risk Based Thinking Approach Market safer and more stable Identifying and mitigating risks Mitigate risks before manufacturing the product and process installation Multidisciplinary approach Full product lifecycle checked from development phase until product / process approval Manage the manufacturing process in front of changes (expected and unexpected) Assessing the manufacturing feasibility Evaluate design changes after product approval Control and react to the changes Adjust the internal audit according to changes frequency Complete Supply chain prevented from risks Conducting Contingency planning reviews Identifying & supporting processes owners Ensuring Customer targets and Quality objectives Implementing corporate responsibility initiatives Organizations need to prevent all risks of change and adapt all processes accordingly

6 AEROSPACE STANDARD TRANSITION AS9100 SERIES 6 IAQG 9100 D/2016 ISO 9001:2015 NEWS AS 9100 new standard based on ISO9001:2015 precise more deeply what is expected from Aerospace stakeholders to their suppliers. It s highlighted how the organization need to pay attention to change and risk management all along the lifecycle of product and/or services. Aerospace stakeholders request also organization to prevent themselves against the risk of knowledge loss. Business continuity becomes very risky when skills and company knowledge are handled by few ones. New standards version are now requesting organization to make sure knowledge and skills are widely shared within their team and knowledge development program exists for becoming more robust against that risk How to manage Process Approach Adapt process on the risk based thinking approach Processes PDCA (Plan, Do, Check & Act) oriented Integrate risk-based thinking in the process definition from the beginning Anticipate and prepare the organization to ensure process, activity and deliveries Continuous improvement approach on all the processes From Setting objectives (P), deploying actions plan (D), Monitoring the results (C) and building lesson learns for deploying new actions for progress (A) Change Prepare the organization regarding change management without negative impact on business Anticipation and preparation of the organization and processes to change management and risk This concept is present in several clauses Organization need to prepare and anticipate changes (expected or not expected) Organization Knowledge Prevent the organization against lost of knowledge that could yield high risk on business continuity Identify and care the knowledge source in the organization Acquire and increase knowledge will help the organization to progress Processes need to integrate the lesson learn step in the procedures Knowledge transfer from experts within the organization is crucial Maintaining and developing knowledge is crucial for a robust organization.

7 7 AEROSPACE STANDARD TRANSITION AS9100 SERIES IAQG 9100 D/2016 ISO 9001:2015 NEWS Both ISO9001 and AS 9100 standards precise requested requirements on the organization context that has changed since previous versions. Standards are now considering that all lifecycle of product and services need to be considered in the scope of management system. It s not anymore only a question of manufacturing or quality management. There is a context around the organization activities and it has to be fully considered. AS9100 is more focusing on business performance, customer satisfactions as deliverables expected. Hereafter, there is a synthesis of new expectations and how to handle this requirements Rationale Interested Parties ( 4.2) Ability to demonstrate that product/services provided are satisfying customer requirements Not only client/customer Any actor in the complete product/service lifecycle is an interested party Organization member, supply chain stakeholders, regulatory institutions, employees, unions,. Documented information ( 7.5 ) Only one terminology for getting justification of existence Specific Procedures are no longer requested Instruction Sheet, procedures, Actions plan, can be called documented information These DI need to be up to dated, known by the largest and retained Planning & Risk Organization are responsible for providing post-delivery services or actions to meet customer satisfaction Technical Support for clients Routine maintenance operations Recalls (When necessary) Warranty management in case of non working products Continual Improvment ( 10) Improvement is now expected as an endless activity and ongoing one. All types of improvement are expected. Not only ones resulting from root cause analysis: Breakthrough analysis Lesson Learns Re-Engineering

8 AEROSPACE STANDARD TRANSITION AS9100 SERIES 8 IAQG 9100 D/2016 ISO 9001:2015 NEWS Product Safety is new requirement from EN9100 even if it was already present somehow. It s clearly highlighted that product should bring what it has been designed for but all along the lifecycle and not only during use. How to Manage within the process Control plan approvals Product Safety Product should bring what it is designed for without causing harm or damages Product Design and Manufacturing Process Robustness (P/D) FMEA Risk analysis Supply chain robustness to fulfill product safety requirements Lesson Learn from experience and field feedback Counterfeited parts is one o f the most important new requirement. In front of a changing world were physical and wire communication become the standard rule, AS9100 request special attention to this matter as it could cause dramatic consequences on final customer. Counterfeit parts prevention (s 8.1.4; 8.4 & 8.7) Prevent the product, processes and supply chain from counterfeit parts introduction risk How to Manage within the process Training and prevention: awareness of counterfeits parts concerns all the organization Each step of parts purchasing process from supplier selection, incoming acceptance until final delivery need to be robust against the risk. Traceability from manufacturers to be guaranteed. Check, test and validation are compulsory Organization need to improve awareness of this risk by controlling each gate obsolescence part management and related supply chain control are main gates for preventing the risk Risk management approach is a key matter in the new standard requirements. It s compulsory that any step from the development until the delivery need to be addressed by Risk management approach. It will bring more robustness to the product as well as process and supply chain How to Manage within the process Risk Management ( 6.1 & 8.1) Risk Based Thinking integrated into the QMS to achieve the planned result Manage the risk at organization and processes level Dedicated process for risk management Deployment of risk analysis in the operation activities All processes from the organization would be concerned by risk analysis approach Realize action plan based on risk analysis The risk management approach need to be applied on all the organization processes

9 9 AEROSPACE STANDARD TRANSITION AS9100 SERIES 9100:2016 NEW REQUIREMENTS New Aerospace standard highlight and precise how human factor need to be considered in the product/service lifecycle. Human interactions need to be considered as full part of manufacturing process and consequently as root cause analysis branch to evaluated in case of non conform product delivered to customer How to Manage within the process Human Factors & Recognize Human Factors importance in Root Cause Analysis and get robust corrective actions Integrate the human error factor as potential root cause and make the related analysis Capitalized human errors based on lessons learned Human interactions are fully part of the process and need to be fully considered in Root Cause analysis In the same way than human factor impact is above described, AS9100 new standard insists on the ethical behavior and awareness of employees. Now, organization need to take all necessary actions in term of communication and training for making sure any employee within the organization have a full knowledge of what would be the impact of its actions or behavior on the product, process and business continuity. How to Manage within the process Awareness & Ethical behavior All the employees must be aware about their importance in the organization and their impact on the final product release Anyone in the organization can explain his role in the process and impacts on it Awareness Direct communication between, manager & employees Communication campaign Training Ethical behavior : Organization should clarify ethical policy and behavior that are expected to be followed by employees All the organization members shall be aware about his role and impact on the product delivery WHAT IMPACT TO EXPECT ON YOUR MANAGEMENT SYSTEM? Maturity of the Management system More advanced Management System LOW IMPACT MEDIUM IMPACT CHANGES ARE MORE SIGNIFICANT THAN FOR THE PREVIOUS REVISION THE IMPACT OF THE CHANGES DEPENDS ON: The Management System current maturity The organization strategic decision to integrate more the different Management Systems More simple Management System MEDIUM IMPACT Keep the same level of integration of the Management system HIGH IMPACT Increase integration of the Management systems Towards more integration of Management systems

10 AEROSPACE STANDARD TRANSITION AS9100 SERIES 10 WHAT IS THE TRANSITION PROCESS? Content & Timeline AS9100:2016 will follow ISO 9001:2015 document structure with the following clauses organization: Transition audit will be planned whatever next audit is RA, SA 1 or / - 3 months tolerance possibility remain possible in TA fixing date IAQG 9100 Transition Audit can t be separated: only 1 audit session for transition Once SA/RA + TA, with positive result, an updated certificate will be edited with no change on 3years cycle and dates. 1st Transition Audit Possible NEW ISO 9001:2015 published AS 9100 Standard & SR003 Published AS 9101& 9120 Published Jan 1 st 2017 June 14th, 2017 Bureau Veritas Certification expected transition period May 14 th 2018 No AS 9100 :2009 valid certificate Sept 23 rd 2015 Oct 2016 Nov 1 st 2016 New 9100 Training for Auditors March 1st, % Transition Audit Critical Period: 120 days before end of EN9100 Certificates Sep 14 th 2018 AS 9100 Series Transition completed HOW CAN BUREAU VERITAS SUPPORT YOU IN YOUR TRANSITION? NEW E-LEARNING AND MONTIONNING TOOL Are available on Bureau Veritas Lead Platform Get trained to the transition at your own pace and without engaging in travel expenses.

11 11 AEROSPACE STANDARD TRANSITION AS9100 SERIES HOW TO GET MORE INFORMATION? STAY UP-TO-DATE VISIT OUR WEBSITE VISIT OUR LEAD PLATFORM AND PURCHASE OUR TRANSITION DIGITAL TOOLS ON LEARN ABOUT THE CHANGES AND THE NEW REQUIREMENTS IN ISO14001:2015 WITH OUR TECHNICAL GUIDE FOR TOP MANAGEMENT - ENVIRONNEMENTAL MANAGER SHARE YOUR QUESTIONS AND DISCUSS THEM WITH YOUR FELLOWS ON LINKEDIN AND TWITTER Join our community Bureau Veritas Certification Follow us on Twitter Bureau Veritas Certification certification.contact@bureauveritas.com