Remerciez-le!

Remerciez @Admin pour avoir partagé cet document gratuitement, de la manière la plus simple, en partageant sur les réseaux sociaux.

Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitat

Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop Failure Mode & Effect Analysis (FMEA) Application Workshop Preparation Guide aCCredo Corp. 13267 SW Bull Mountain Rd. Tigard, OR 97224 Ed Metzler -- President 503-624-2124 503-805-7758 (cell) 503-624-5723 (fax) emetzler@accredo.com aCCredo Corp. Page 1 of 12 © 1998-2002, aCCredo Corp. Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop Background -- Failure Mode and Effect Analysis Introduction: Failure Mode and Effects Analysis (FMEA) is a brainstorming, prioritization, and action item definition risk assessment process performed by a multi-disciplined team from design, manufacturing, quality and field engineering. The goal of FMEA is to assure that the most critical failure modes of a system, product design, process or security approach have been identified and addressed before they occur. FMEA is, therefore, an anticipatory process utilized to reduce overall costs and improve customer satisfaction. For years, FMEA has been an integral part of product development and has grown to be one of the most powerful and practical process control, reliability and risk assessment tools for manufacturing environments. Most notably, the automotive industry has adopted FMEAs for evaluating risk in the design and manufacturing of automobiles. The American Society for Quality (ASQ) and the Automotive Industry Action Group (AIAG) chartered the ASQ/AIAG Task Force to standardize FMEA reference manuals, procedures, reporting formats and technical nomenclature. These resources are used for FMEA by Chrysler, Ford, and General Motors internally and in their respective supplier Quality systems. FMEA is a requirement for companies subscribing to QS-9000. The US Military (i.e., Air Force, Navy) require FMEAs for all systems to ensure safety as well as reliability. And, for the most part, FMEA has become an indispensable tool for the aerospace industries. Sematech references FMEA in their FMEA Guide for Continuous Improvement for the Semiconductor Equipment Industry (Sematech 92020963A). The European Union (EU) ISO 9004 quality standard identifies FMEA as an effective tool for insuring quality product design and manufacture. The FDA has issued a quality planning bulletin (FDA 90-4236) urging implementation of FMEA during pre-production phases. Although there are several types of FMEAs (e.g. system, product, design, process, materials, automation, security, etc.) and approach varies from site to site, one common factor has remained through the years -- resolving potential problems (risks) before they occur. aCCredo Corp. Page 2 of 12 © 1998-2002, aCCredo Corp. Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop Table of Contents BACKGROUND -- FAILURE MODE AND EFFECT ANALYSIS.....................................................................................2 FMEA PLANNING....................................................................................................................................................................4 FMEA PLANNING CHECKLIST...........................................................................................................................................6 FMEA PARTICIPANT SELECTION.....................................................................................................................................7 FMEA WORKSHOP MATERIALS LISTS..........................................................................................................................11 FMEA CONFERENCE ROOM SELECTION.....................................................................................................................12 aCCredo Corp. Page 3 of 12 © 1998-2002, aCCredo Corp. Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop FMEA Planning Leader/Facilitator pre-meeting: Note: use the FMEA Planning Checklist for documenting agreement The Facilitator should conduct a pre-meeting with the FMEA session Leader and one or two key session participants (co-leaders) prior to first session announcement. A checklist is included at the end of this section to document the meeting outcomes. • Select the target product or process for which the FMEA will be conducted. Usually this product or process is known prior to the pre-meeting. • Define scope of the FMEA (i.e. match level of detail and complexity with available time). For example, rather than selecting an system assembly, focus instead on the sub- system. The purpose of limiting the scope is to assure that closure can be attained on specific action items rather than being overwhelmed by complexity. A model, in either drawing or physical form, is necessary to provide boundaries to keep the FMEA workshop on track. This model should be presented by the Leader at each session • Identify target customers to consider when brainstorming failure modes. These customers may be internal or external. For example, the customers for a new Pen design might be the actual end-user who installs it in their printer. In that case failure modes considered would be established from their point of view. An example of an internal customer might be the production organization in the case of a new manufacturing process. It is usually necessary to select only a single customer (e.g. the external end-user) or class of customers (e.g. internal users of an automation system or new process). • Define the level of detail and sources of ideas that will be considered as failure modes. For example, it may be more important to deal with interfaces between processes rather than the detail of an individual process step. We call this stratification -- segmenting the problem into manageable chunks. Facilitator note: a good break point is 200 failure modes. More than 200 are extremely difficult to manage with an affinity diagram. • Define the baseline on which failure severity, frequency of occurrence and detectability should be related. Should brainstorming and risk assessment be based on results from prototype builds, prior comparable products, or field failure analysis? Setting a baseline is very critical since a product or process development effort usually follows a plan of record; with multiple steps until final release. • Select appropriate participants (use participant guidelines). aCCredo Corp. Page 4 of 12 © 1998-2002, aCCredo Corp. Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop Leader/Facilitator pre-meeting (continued): • Describe roles and responsibilities of the Leader, co-leaders and participants (see roles and responsibilities section). • Set expectations for time involved (usually two 4-5 hour FMEA sessions). Assure commitment for Leader and co-leaders to actively participate in both sessions. If unable to attend both sessions, assure alternate Leader is assigned or reschedule. • Agree on an approach for follow-up to assure action items are completed and the solutions re-evaluated with the FMEA matrix. A database is usually required to enter, track and follow-up on issues resulting from the FMEA sessions. We recommend eRoom. • Review FMEA process by briefly stepping though the session instruction guide. • Schedule meetings with one week between Sessions 1 and 2 if possible. • Identify conference room to be used and assure it has the appropriate layout and features. (use Conference Room Selection guidelines). • Finalize Leader and co-leader identification for the session. • Request that the Leader send out invitation two weeks prior to the session. aCCredo Corp. Page 5 of 12 © 1998-2002, aCCredo Corp. Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop FMEA Planning Checklist Facilitator/Leader Checklist: 1. Target product or process: 2. Leader and co-leader identification: 3. Customers: 4. Perspective (point-of-view): 5. Scope: 6. Stratification or level of detail: 7. Baseline: 8. Roles and responsibilities (see write-up): 9. Participant selection: 10. Workshop process clarification: 11. Schedule (Date, Time and location): 12. Invitations: 13. Handouts: 14. Action Item follow-up methodology: aCCredo Corp. Page 6 of 12 © 1998-2002, aCCredo Corp. Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop FMEA Participant Selection Selection Guidelines: The following are suggestions for the membership of FMEA teams. Team size should be between 6 and 12 participants with 10 being optimal. Product FMEA • Design/Project Manager -- Leader • Designer(s) -- Product Design • Manufacturing Development Engineer(s) -- Process Design • Production Engineer(s) -- Process Capability • Quality/Customer Engineer(s) -- End User • Product Engineer(s) -- End User • Procurement Engineer(s) -- Supplier Relationship • Supplier Engineer(s) -- Outsourced Design Process FMEA • Manufacturing Development Engineering Manager -- Leader • Manufacturing Development Engineer(s) -- Process Design • Designer(s) -- Product Design • Production Engineer(s) -- Process Capability • Quality/Customer Engineer(s) -- End User • Product Engineer(s) -- End User • Procurement Engineer(s) -- Supplier Relationship • Supplier Engineer(s) -- Outsourced Process Equipment/Processing • Materials Specialist/Chemist(s) -- Material Selection • Technician(s) -- Equipment • Process Operator(s) – Operations aCCredo Corp. Page 7 of 12 © 1998-2002, aCCredo Corp. Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop Selection Guidelines (cont.): Material FMEA • Materials Specialist/Chemist Manager -- Leader • Materials Specialist/Chemist(s) -- Material Selection • Production Engineer(s) -- Process Capability • Quality/Customer Engineer(s) -- End User • Product Engineer(s) -- End User • Procurement Engineer/Buyer(s) -- Supplier Relationship • Supplier Engineer(s) -- Outsourced Materials • Technician(s) -- Equipment • Process Operator(s) -- Operations Automation FMEA • Automation Systems Design Manager -- Leader • Automation Design Engineer(s) -- Software/Hardware Design • MIS Engineer(s) -- Software Design • Production Engineer(s) -- Process Capability • Technician(s) -- Equipment • Process Operator(s) -- Operations • Facilities Engineer(s) -- Production Area Design • Procurement Engineer(s) -- Supplier Relationship • Supplier Engineer(s) -- Outsourced Automation Equipment aCCredo Corp. Page 8 of 12 © 1998-2002, aCCredo Corp. Doc # 10901 FMEA Preparation Guide 060302.doc Revision Date: 6/3/2002 Facilitators’ Guide for Product FMEA Workshop FMEA Roles and Responsibilities Facilitator: The Facilitator shall have a working knowledge of the ACCREDO FMEA process. Experience with statistical methods uploads/Geographie/ fmea-preparation-guide.pdf