Safety related product corrective action

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Rosamund Stevens
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Safety related product corrective action (PCA) - Domain (due diligence) research Research phase 1 Potentially relevant standards Research phase 2 Stakeholder interviews

2 Safety related product corrective action (PCA) - Domain (due diligence) research Research phase 1 Potentially relevant standards Research phase 2 Stakeholder interviews Conclusions and recommendations Proposal for good practice corrective action programme Outline structure for proposed PAS Copyright 2017 BSI. All rights reserved 2 03/07/2017

4 Stakeholder feedback Telephone interviews with 30 stakeholders across a range of stakeholder interests the potential benefits of the proposed project; their interest in participation in any future PAS development; experience in respect of existing product corrective action/ recall approaches; recommendations as to any existing codes/ approaches that could be used or should be taken into account in developing a new code; the potential relevance of the proposed PAS to Product Corrective Action oversight activity. Copyright 2016 BSI. All rights reserved.

5 Stakeholder feedback Principle recommendation A new UK code of practice for product recall (or other corrective action) should: be clearly focussed on safety related corrective action and recall; provide clear guidance as to where responsibilities belong; be generic in nature. (i.e. not biased towards any particular sector); set out guidance that is sufficiently specific and robust to preclude interpretation; encourage the preparation of product corrective action plans in advance of actual need; offer a range of tools to assist suppliers in their assessment of risk and determination of corrective action or recall, taking account of RAPEX guidelines; avoid conflict with existing sector specific schemes (e.g. automotive); promote the early sharing of information; highlight examples of recall notices that have been effective; facilitate the involvement and engagement of regulatory bodies with their role. Copyright 2016 BSI. All rights reserved.

6 Conclusion New, UK centric guidance on safety related product recall and other corrective actions would benefit both business and regulatory bodies. Variety of approaches currently available for use by interested parties; Of these, two are particularly relevant to those placing products on the market, in the UK; Choice of possible approaches not necessarily helpful to those having responsibility for ensuring the safety of products placed on the market, particularly for the first time (business/ regulators); Any new guidance should: take due account of UK regulatory requirements major on forward planning not emergency action avoid conflict with existing sector schemes operating in UK Guidance should be targeted at both business and regulatory bodies Copyright 2016 BSI. All rights reserved.

7 PAS 7100 Part I Outline content Code of practice Clause 1 Scope Clause 2 Terms and definitions Clause 3 Context, purpose and principles Roles and responsibilities (in law) Concise statement of what PAS is intended to achieve Underlying principles Clause 4 Organizational commitment to product corrective action (PCA) Clause 5 PCA programme development Clause 6 PCA programme approval Clause 7 PCA programme implementation Clause 8 Post-incident and periodic, review Clause 9 PCA programme reporting Copyright 2016 BSI. All rights reserved.

8 PAS 7100 Part I Outline content / continued Code of practice continued Annexes providing: Risk classification support and other tools to assist decision-making as to the need for the initiation of corrective action/ product recall Examples of good practice in the content, presentation, and publication of product recall notices, etc. Example of what a good practice recall action looks like. Bibliography- List of relevant additional reading with sources. Copyright 2016 BSI. All rights reserved.

9 PAS 7100 Part II Outline content Guidance for regulatory bodies Clause 1 Scope Clause 2 Terms and definitions Clause 3 Context, purpose and principles Clause 4 Guidance on the understanding and application of risk assessment methods Clause 5 Guidance on support that could be provided for client suppliers in developing their PCA programmes Clause 6 Guidance on engagement with client suppliers in incident monitoring and oversight Annexes Material to assist the training of officers potentially engaged in support and oversight activities Bibliography Copyright 2016 BSI. All rights reserved.

10 PAS 7100: 2018 Safety related product recall and other corrective action Part I Code of good practice Part II Advice for regulators THE PAS PROCESS Copyright 2017 BSI. All rights reserved 10 03/07/2017

11 What is a BSI PAS? Fast-track, consensusbased standardization Client sponsored, enabling: facilitation by a dedicated Project Manager to PAS 0 development in 6 to 12 months use of proven, transparent, consensus-building process support for certification schemes and quality marks co-branding with clients and stakeholders international application Copyright 2017 BSI. All rights reserved 11 03/07/2017

12 What is a BSI PAS? Frequently: Developed in response to a pressing market need, often for an emergent market, technology, service or public policy interest Effective means of quickly introducing standardization Tests the value or validity of a particular approach or methodology Applied internationally as well as in UK Basis for formal standardization (e.g. British, European or International Standards) Copyright 2017 BSI. All rights reserved 12 03/07/2017

13 PAS 7100 Stakeholders Electrical Safety First ROSPA BSI Consumer Panel BRC TESCO Retail Consumer Industry AMDEA SMMT BTHA SAMSUNG WILCO Chief Fire Officers Association. Fire Protection Association Emergency services Steering Group Legal Baker & Mckenzie BEIS Copyright 2016 BSI. All rights reserved. Government Trading Standards CTSI Association of Chief Trading Standards Officers (ACTSO)

14 PAS 7100 Overview of development process Pre PAS PAS development 8 months Consensus building Agree scope of PAS Develop initial draft Steering Group Public consultation Steering Group Publication Sponsor & stakeholders Technical author 20 to 25 stakeholders Review panel & public comment 20 to 25 stakeholders 03/07/2017

15 Overview of the PAS 7100 process Project contracted Project Initiation Steering Group key experts in the subject area SG Review & confirm Peer Review Group Unlimited number SG Post- Review Meeting BSI Domain Research & Proposal WGPRS meeting BEIS/ BSI Confirm Project, Title Scope & objectives Technical Author Briefing Prepare Provisional Draft Prepare 1st Draft SG input & 1st Meeting Peer Review & Public Consultation Wider/public consultation independently facilitated by BSI. The peer group may include: Formal standards committees Government departments Trade associations Technical Experts Other industry stakeholders Consumer groups BSI & TA Finalize Draft SG Review & confirm Stakeholder Engagement Publication 11 Months 15

16 PAS 7100 Schedule Stage Activity Indicative date Project Initiation Meeting (PIM) 29/03/ Domain Research/ Analysis commences 05/04/ Working Group engagement commences 06/04/ Working Group engagement completed 28/04/ Prepare Landscape Review Report and proposal for PAS scope- circulate to WG 12/05/ BEIS WG meeting to agree Report and PAS scope proposal 24/05/ Finalise formal proposal 02/06/ PAS Initiation Meeting (with BEIS) & TA Induction 07/06/ Tech. Author outline drafting commences 08/06/ Formal stakeholder engagement commences 08/06/ First draft completed 07/07/ SG constituted 07/07/ st Draft circulated to Steering Group and Working Group 10/07/ a Notification of draft status and opportunity for comment to WGPRS 10/07/ SG cosg 1 st meeting - Comment disposition and draft amendment 17/07/2017 mments submitted /07/2017

17 PAS 7100 Schedule Stage Activity Indicative date SG recommended changes incorporated in draft 18/08/ Second (Review) draft circulated to SG for confirmation 21/08/ SG comments on review draft received 04/09/ Review draft completed 15/09/ Client approval obtained 22/09/ Peer Review and Public comment period commences 25/09/ a Notification of draft status and opportunity for comment to WGPRS 25/09/ Peer Review and Public comment period closes 23/10/ Review comments collated and circulated to SG 27/10/ SG 2 nd meeting Comment disposition and draft amendment 08/11/ SG recommended changes incorporated to create third draft. 24/11/ Third draft edited to create final draft. 04/12/ Final draft circulated to SG for final review 04/12/ SG final comments submitted 11/12/ Final draft completed 20/12/ Final draft submitted to client for sign-off 21/12/ Client sign-off received 05/01/ Draft to design 08/01/ Design completed 26/01/ Designed PAS to client for approval 29/01/ Client approval for designed PAS 05/02/ Publication & issue of any approved copies w/c 15/02/2018 TOTAL ELAPSED TIME 11 Months

18 PAS 7100 Critical Dates Stage Activity Indicative date SG 1st meeting 28/07/2017 Draft adoption, Comment disposition & draft amendment Peer Review and Public comment period commences 25/09/ Peer Review and Public comment period closes 23/10/ SG 2 nd meeting 08/11/2017 Comment disposition and draft amendment Final draft completed 20/12/ Publication & issue of any approved copies w/c 15/02/2018

19 PAS 7100 for both businesses and regulatory bodies: Part 1: Businesses A generic code of good practice for monitoring, assessing, notifying and recalling/ correcting sub-standard products, bringing together existing guidelines: Organizational commitment to product recall/ corrective action Preparation of a product corrective action programme Risk assessment and determination of appropriate recall or corrective action Programme implementation Post-incident and periodic review Reporting and sharing of information Part 2: Regulatory bodies Guidance on the actions expected of a regulator: Understanding and application of risk assessment methods Support that an enforcer can provide to businesses Engagement with businesses in incident reporting and monitoring Training of officers engaged in support and oversight activities Copyright 2016 BSI. All rights reserved.

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