AEROSPACE INDUSTRY. EN 9100 Transition Guide THE KEY POINTS OF THE 2016 VERSION

Transcription

1 AEROSPACE INDUSTRY EN 9100 Transition Guide THE KEY POINTS OF THE 2016 VERSION

2 CONTENTS THE ISSUES AT STAKE IN THE REVISION...04 A sector at the heart of global economic issues...04 Standard EN 9100, a prerequisite for the industry at international level...04 Why did EN 9100 need to change?...05 THE MAJOR IMPACTS OF THE 2016 VERSION...06 A new vocabulary to be taken into account...06 A new approach to risk management...06 Strengthened awareness and training actions for personnel...07 Changes taking account of a new global environment...07 INTERPRETING THE NEW ELEMENTS...08 OUR PREPARATION SOLUTIONS...15 THE TRANSITION PROCEDURES...16 A major partner of the Aviation, Space and Defence industry and a world leader in its field, AFNOR Certification has from the outset contributed to the reliability of this certification in partnership with GIFAS* and QUALIFAS**. AFNOR Certification provides local support wherever your organization is established, thanks to the international deployment and multi-lingual skills of our Aerospace Auditors, selected for their experience in your business segments and their ability to adapt to the realities on the ground. Issuing such trusted high-profile hallmarks as NF, AFAQ and the EU Ecolabel, AFNOR Certification enables companies and professionals to gain recognition for their strategies through quality certifications. With over 70,000 sites certified in over 100 countries, AFNOR Certification delivers certification and assessment services and engineering for 270 categories of goods and services. Click the following link for more information: * French Aerospace Industries Association. ** Association for Quality Supplies for the French Aerospace Industries.

3 The key points of the 2016 version INTRODUCTION In an industrial era marked by the lengthening and ever greater internationalization of supply chains, but also by the acceleration of technical or technological breakthrough innovations, EN 9100: 2016 demonstrates its capacity to adapt to these fundamental changes. It is also makes a decisive contribution to developments in an aviation and space industry that is increasingly risk-aware, ethical, effective and safe. Overall, these developments represent significant changes for companies, changes that must be anticipated and be the subject of planned targeted actions during the transition period. For each of these new challenges, AFNOR Certification is there to support its customers and all players in the industry in terms of awareness, training and optimal organization in their preparation for the new version. For industry players, the first imperative will be consideration of timing, since unlike ISO 9001: 2015 with its three-year transition period, companies concerned will only have two years within which to arrange for their certification audit based on the new 2016 version of the AS/EN/JISQ 9100 series of standards. The deadline for completion of the transition is set at 15 September 2018, when current certificates will no longer be valid. Audits scheduled from 15 June 2017 will be conducted based on the 2016 version of EN To help you best prepare for this transition, AFNOR Certification is pleased to present this guide for transition to the 2016 version. Its purpose is to explain the keys to understanding the changes in the standard and to set out the transition procedures. More than ever, you can count on the support and guidance of AFNOR Certification and its auditors for confidently migrating to the new standards. Happy reading! Franck Lebeugle, Managing Director of AFNOR Certification Acknowledgments: we would like to thank all the people that were even remotely involved in preparing this guide. The comments on the main changes were written by auditors with aerospace expertise: Catherine Bonnicard, Laurent Hopsort and Michel Frances. Michel Frances is also a member of the EAQG working group and was involved in drafting the new standard EN 9100: Publication date: March EN 9100 Transition Guide 3

4 THE ISSUES AT STAKE IN THE REVISION A sector at the heart of global economic issues The aviation, space and defence market represents a key sector in the global economy, with revenue in excess of $630 billion in 2014 in Europe and the United States. In France, the aviation, space, defence and security industry alone represented EUR 50.8 billion in 2014 of which 82 % from exports, the largest national trade surplus. It is the source of 180,000 highly skilled jobs, and the entire industry is estimated to employ 350,000 people (over 50,000 hired in the last four years). Standard EN 9100, a prerequisite for the industry at international level The international standards EN 9100 (design and manufacture of aerospace products), EN 9110 (maintenance) and EN 9120 (storage and distribution activities) are the most widely used by the aerospace and defence sector. They play an essential role with certification to these standards virtually a prerequisite for major contracting authorities, offering reassurance that organizations have fulfilled and addressed the requirements relating to quality, safety, lead-time compliance and cost control. In fact, Boeing and Airbus hold certification to this standard, and 90 % of all organizations operating in the industry are also certified, major players and SMEs alike. Over 18,900 certificates are currently valid. AFNOR Certification has a strong presence in this international market, with 5 % of certifications awarded worldwide. 4

5 The key points of the 2016 version Why did EN 9100 need to change? In 2015, ISO 9001, the most widely used management standard (1.1 billion certificates) underwent some major changes. Most sector-specific standards are expected to integrate these fundamental changes while adding requirements specific to the industry branch. EN 9100 had to be updated to stay aligned with ISO 9001 and this was made all the more necessary by the fact that many companies combine double, triple or even quadruple certification. The new AS/EN/JISQ 91XX standards therefore share a common structure with ISO 9001 with seven sections of requirements instead of the previous five. Similarly, the risk management and prevention approach of ISO 9001: 2015, evidently very present in the world of aerospace, is now universally shared. EN 9100 Transition Guide 5

6 THE MAJOR IMPACTS OF THE 2016 VERSION A new vocabulary to be taken into account The series of standards 9100/110/120: 2016 continue use of the following terms which reflect essential concerns of the aerospace sector: counterfeit part, safety of goods, obsolescence, ethical behaviour, human factors, dismantlement, life cycle of goods, suspect parts, life-limited parts. These vocabulary elements are prominent in the key points of the new standard and are used to construct foundational requirements. A new approach to risk management Responsibility extended to the entire supply chain The most challenging aspect of the new standard is without doubt the obligation required of any company to ensure control of quality and safety of externally provided goods and services, not only in the case of tier-1 suppliers, but throughout the supply chain. Companies therefore assume major responsibility as regards detection of counterfeit parts, and, where applicable, must be able to demonstrate to customers that they have ensured that their suppliers have put in place specific control processes related to this requirement. Strengthening of the good's life cycle concept Similarly, the standard states that, the organization shall plan, implement and control the processes needed to ensure the safety of goods during their entire life cycle. What this means in practice is that no company may claim to its customer that it was unaware that some of the parts designed and supplied by its providers are difficult to recycle, contain critical items or have become obsolete due to advances in technologies. On the contrary, the new standard requires the assessment of hazards and mitigation of associated risks, the management of safety critical items, the analysis and reporting of occurred events affecting safety, communication of these events and training of personnel. 6

7 The key points of the 2016 version Strengthened awareness and training actions for personnel This gives rise to the need for strengthening of knowledge and skills in the personnel concerned. Similarly, given the new standard's requirements on the prevention of counterfeit parts obsolescence monitoring of parts, traceability of parts and components to their authorized original manufacturers, verification and test methodologies to detect counterfeit parts, monitoring of counterfeit parts, quarantine and reporting of suspect goods... it is imperative that organizations implement awareness and training actions on these key points. These actions are also expressly specified and controlled during the certification audit. Auditors will have to verify employees level of knowledge on these aspects. Changes taking account of a new global environment The new standard, by requiring that organizations determine and take actions to address risks and opportunities no longer thinks in terms of just risks. It gives full prominence to opportunities, in other words innovation, and in particular breakthrough improvements. In addition, by directly linking an organization s quality policies and objectives to its strategy and its background, EN 9100: 2016 also takes account of the specific constraints of companies, especially those of SMEs. For instance, they will be able to demonstrate why some requirements in the standard are not applicable or can be simplified in certain situations through their background data (area under consideration, market position, etc.). Another significant change: environmental aspects are also strengthened, via good life cycles, ethical behaviour and control over conditions of supply of goods and services; environmental aspects will be audited. * These standards are prepared by the IAQG (International Aerospace Quality Group) within the ICAO (International Civil Aviation Organization). They receive the EN 9100 designation in Europe, AS 9100 in America and JISQ in the Asia-Pacific region. EN 9100 Transition Guide 7

8 INTERPRETING THE NEW ELEMENTS ISO 9001 version 2015 and EN 9100 version 2016: the impacts on your Quality Management System Background of the organization Leadership Planning Support Operation Performance evaluation Improvement 4.1 Understanding the organization and its background 4.2 Understanding the needs and expectations of interested parties 4.3 Determining the scope of the QMS* 4.4 QMS* and its processes 5.1 Leadership and commitment 5.2 Environmental policy 5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8.1 Operational planning and control 8.2 Good and service requirements 8.3 Design and development 8.4 Control of externally provided processes, goods and services 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement 8.5 Production and service provision 8.6 Release of goods and services No impact or limited impact Medium impact Major impact 8.7 Control of nonconforming outputs * Quality management system. 8

9 The key points of the 2016 version Section by section Understanding the organization and its background 4.1 The organization must analyze its background (internal and external issues) for the purpose of adjusting aspects of its quality management system (QMS) if necessary. The 2016 version does not require any specific method but strategic marketing tools such as SWOT** and PESTEL*** could enable monitoring and regular updating of this information. Understanding the needs and expectations of interested parties 4.2 The 2015 version of ISO 9001, integrated into EN 9100, invites organizations to think about the players in their ecosystem who could influence their activities, i.e. interested parties. Organizations should determine the relevant parties (customers, end users, employees, suppliers, authorities, shareholders, consumer associations, financial backers, etc.) and identify their expectations that could influence the organization's goods and/or services. Determining the scope of the QMS 4.3 Considering the issues and expectations of interested parties may prompt the organization to review the scope of its QMS. The scope is an item of documented information that specifies the boundaries and applicability of the QMS, as well as the goods and services concerned. Any requirement may be excluded from the scope (and no longer only those in 7) provided that it has no effect on the organization's ability or responsibility to provide compliant goods and/or services. Any decision to not apply a requirement in the standard must be justified. * SWOT: method used to analyze an organization's strengths and weaknesses, as well as the opportunities and threats in its environment. ** PESTEL: an analytical tool used to identify external influence factors on an organization: Political, Economic, Social, Technological, Environmental and Legal. Leadership and commitment 5.1 Incorporating the term leadership places greater responsibility upon top management. Top managers must demonstrate their commitment, especially through their accountability for the effectiveness of the QMS and their support for the organization's other managerial functions. EN 9100 Transition Guide 9

10 Actions to address risks and opportunities 6.1 Aiming to serve as an ever more effective prevention tool, the standard encourages organizations to identify risks and opportunities, and the actions to address them. Risks and opportunities must be determined based on the background and on interested parties' expectations. Although the 2015 version does not require any specific method, we would advise you to use a risk analysis method. Planning of changes 6.3 Any changes affecting the QMS (processes, activities, infrastructures, equipment, etc.) must be controlled and carried out within a project approach (objectives, control of the consequences, required resources and responsibilities). The aim is to reduce any negative impacts and problems that could arise during a change. The standard therefore strengthens its role as a prevention tool. Organizational knowledge The 2016 version considers that an organization's value does not lie solely in its bottom line and must be broadened to encompass its information capital. The organization must therefore identify the key knowledge required for implementing its processes and obtaining compliant goods and services: statutory and regulatory requirements, lessons learned, knowledge-sharing, etc. Awareness 7.3 Personnel must be aware of their contribution to the safety of goods and the importance of ethical behaviour. They must be able to explain their own role and how they contribute to quality in their activities, be able to explain the purpose of the good and be aware of the potential risks if nonconforming goods are delivered. Control of documented information Organizations must define the provisions made for the protection of documented information managed electronically. These may for example concern protection against loss, unauthorized modification, unintended alteration or fraud. 10

11 The key points of the 2016 version Operational planning and control 8.1 This section determines the requirements for operational planning and control of goods and services and the planning should take account of: obsolescence of goods prevention, detection and removal of foreign bodies handling, packing and storage There are also requirements in terms of determining the necessary resources for ensuring ontime delivery of goods and services. Operation risk management This clause concerns risks in the operational processes that are needed for the provision of goods and services. In the aviation, space and defence industry, risk is generally characterized by the likelihood of occurrence and the severity of the consequences of a known risk. Organizations should in particular take account of the following in their planning and implementation of operation risk management: allocation of risk management responsibilities identification, analysis and communication of risks implementation of risk mitigation measures for risks that exceed the defined risk acceptance criteria Safety of goods (new clause) This is a new term included in standard 9100: Organizations must plan and implement the processes needed to ensure the state in which a good is able to perform without presenting any risk of harm to persons or damage to property. These processes may for example concern provisions made for: EN 9100 Transition Guide 11

12 risk assessment and management of associated risks (see 8.1.1) management of safety critical items analysis and reporting of occurred events affecting safety communication of these events and training of personnel Prevention of counterfeit parts (new clause) This is a new term included in standard 9100: Organizations must plan and implement the processes needed to prevent counterfeiting of parts or the use of suspect parts (material, component) in goods delivered to the customer. These provisions may for example include: training of appropriate personnel in awareness and prevention of counterfeit parts implementation of a monitoring programme for obsolescent parts control over outsourcing from original manufacturers, authorized distributors or other approved sources traceability of parts and components from authorized manufacturers verification and test methodologies to detect counterfeit parts monitoring of reports on counterfeit parts from external sources quarantine and reporting in the case of suspected counterfeiting or counterfeit parts detected 12

13 The key points of the 2016 version Review of the requirements for goods and services Review of the requirements for goods and services must be coordinated with the applicable functions of the organization. If on examination, the organization determines that certain customer requirements cannot be met or can only be partially met, the organization must negotiate a mutually acceptable requirement with the customer. Design and development inputs Organizations can now consider any type of data as a design and development input, such as benchmarking, feedback from external providers, internal reports, potential consequences of obsolescence, etc. Control of externally provided goods and services 8.4 Controlling the compliance of goods, services and processes supplied by external providers has been reinforced in the 2016 version. The organization must commit to determining its requirements, the type and extent of control extending to the lowest sub-tier (tier-1, tier-2 suppliers, etc.) and must communicate clear information to external providers. Control of externally provided goods and services The organization must identify and manage the risks associated with the selection and use of direct and sub-tier external providers. It must therefore require them to apply appropriate controls to their own sub-tier suppliers so that the entire supply chain is secured. Post-delivery activities 8.5 The standard does not impose any particular methods, but requires all organizations to integrate their post-delivery activities (warranties, insurance, maintenance, recycling, after-sales, etc.) into the scope of their QMS. EN 9100 Transition Guide 13

14 Control of changes An event may sometimes affect the ability of the processes or equipment to provide a good or service meeting the required level of quality within the specified lead-time. With the 2016 version, the organization is committed to reducing the consequences of such events and keeping track of the results of any changes made. Control of nonconforming outputs 8.7 The 2016 version requires organizations to identify and control any nonconforming outputs. These outputs are the outcomes of the activities of a process: information, components, intermediate elements, etc. Counterfeit parts, and suspect parts, must be controlled to prevent their entry into the supply chain. Monitoring, measurement, analysis and evaluation 9.1 The 2015 version of ISO 9001 requires the organization to improve its approach to monitoring, measurement and the associated resources. The required documentation mainly focuses on evidence that activities have been carried out (metrics, measurement reports, test reports). As part of the transition, we would advise you to review your monitoring activities. Nonconformity and corrective action When evaluating the need for action to eliminate the cause(s) of a nonconformity, the organization must be able to identify actions associated with human factors. 14

15 The key points of the 2016 version OUR PREPARATION SOLUTIONS Want to find out more about the changes associated with this revision and gain a better understanding of how they impact your certification? Regional events (3 h - free) Attend the workshops organized in your local area designed to inform you about the new requirements of this new standard and the transition procedures. Find a date near me Webinars (1 h - free) Can t travel? Then spend an hour reviewing the main impacts of the revision with our experts and ask all your questions. > Dates to be communicated shortly Want an appraisal of your level of readiness so that you can plan ahead on actions and adjustments to help you sail through your transition audit with confidence? Online test (20 min free for AFNOR Certification customers) With this summary test you can check your performance against the main new subject areas in the 2016 version. You will receive a report helping to identify the necessary actions for a successful transition. I want to do the test Assessment visit Are you already well ahead with your preparations for EN9100/110/120 version 2016? Ask for a trial run before your audit for optimal preparedness and peace of mind. Your auditor will give you the keys to understanding and applying these new versions, while helping you define your means and resources, and introducing you to AFNOR Certification's auditing techniques and the required level. Find out more... EN 9100 Transition Guide 15

16 TRANSITION PROCEDURES Publication of standards EN 1900/110/120 and 9101 version 2016 SWITCH OVER AT THE RIGHT TIME Publication Deadline online for sending of the auditor us your training transition modules plan From this date all companies are audited based on the 2016 version Deadline for transition to EN 9100/110/120 version 2016 End of validity of your EN 9100/110/120 certificate DECEMBER /03/ /06/ SEPTEMBER YEAR TRANSITION PERIOD Decide now on your plan for transition to the 2016 version PLAN YOUR TRANSITION Your transition audit can be conducted at your next renewal or follow-up audit, or at a special audit. For optimal cost effectiveness in terms of mobilizing your teams, we recommend that you arrange for your transition audit at an already scheduled follow-up or renewal audit, between 15 September 2017 and 15 September Speak to your AFNOR Certification contact who will help you decide on the transition plan best suited to your situation. 16

17 The key points of the 2016 version Transition at your renewal audit YOUR CURRENT CERTIFICATE EXPIRES BETWEEN 15 June 2017 and 15 September 2018 Planning your RENEWAL audit 15 September 2018 Up-to-date by the 2016 version transition deadline 15 June 2017 Applicable audit criteria 9100/9110/9120: 2016 Make your transition to the 2016 version The audit duration is the same as a renewal + extended time (*) New v2016 certificate with a 3-year validity period - 1 day * The minimum duration of your audit is fixed by EN The extended time added to this duration is mandatory and necessary for verification of compliance with the new requirements. EN 9100 Transition Guide 17

18 Transition at your follow-up audit YOUR CURRENT CERTIFICATE EXPIRES ON 15 September 2018 Planning your FOLLOW-UP audit 15 September 2018 Up-to-date by the 2016 version transition deadline 15 June 2017 Applicable audit criteria 9100/9110/9120: 2016 Make your transition to the 2016 version The audit duration is the same as a follow-up + extended time (*) Your certificate is re-issued in v2016. The validity period is from the issue date of your v2009 certificate + 3 years - 1 day To help you with your transition planning we can carry out a preparatory review on- or off-site. * The minimum duration of your audit is fixed by EN The extended time added to this duration is mandatory and necessary for verification of compliance with the new requirements. 18

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