FMEA Description For ISO 9001

In the proposed ISO 9001:2015, as per clause

4.4.2 sistema de gestión de la calidad y sus procesos

5.1.2 Liderazgo y compromiso

6.1 Acciones para tratar riegos y oportunidades

8.3 Diseño y Desarrollo de los productos y servicios

8.5.1 Producción y prestación del servicio

8.6.5 Liberación de los productos y servicios

9.1 Seguimiento, medición, análisis y evaluación

9.2 Auditoria Interna

10.2 No conformidad y acción correctiva

there is emphasis on "risk based thinking"? Do you think FMEA is proper tool for it?

Pretesh B. Quality Consultant at APB Consultant Contribuidor principal

Fundamental And Concepts Of Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a method designed to identify and fully understand potential failure modes and their causes, and the effects of failure on the system or end users, for a given product or process.It helps us to assess the risk associated with the identified failure modes, effects and causes, and prioritize issues for corrective action. Using FMEA we can identify and carry out corrective actions to address the most serious concerns. An FMEA is an engineering analysis done by a cross-functional team of subject matter experts that thoroughly analyzes product designs or manufacturing processes early in the product development process, so as to find and correct weaknesses before the product gets into the hands of the customer. An FMEA should be the guide to the development of a complete set of actions that will reduce risk associated with the system, subsystem, and component or manufacturing/assembly process to an acceptable level. If FMEA is effectively used throughout the product life cycle, it will result in significant improvements to reliability, safety, quality, delivery, and cost. Just performing an FMEA just to fill a checkbox in the Product Development Process and then filing it away, never to be seen again, is a waste of time and adds no value.As a tool in risk evaluation, FMEA is considered to be a method to identify severity of potential effects of failure and to provide an input to mitigating measures to reduce risk. In many applications, FMEA also includes an estimation of the probability of occurrence of the causes of failure and their resultant failure modes. This broadens the analysis by providing a measure of the failure mode ‘ s likelihood. To minimize risk, the likelihood of failure occurrence is reduced which increases product or process reliability. FMEA is a tool that is instrumental in reliability improvement. There are three basic cases for which FMEA process is to be applied, each with a different scope or focus:

Case.1: New designs, new technology, or new process. The scope of the FMEA is the complete design, technology, or process.

Case 2: Modifications to existing design or process.The scope of the FMEA should focus on the modification to design or process, possible interaction due to the modification and field history and can include changes in regulatory requirements.

Case 3: Use of an existing design or process in a new environment, location, application, or usage profile (including duty cycle, regulatory requirements, etc.).

The primary objective of an FMEA is to improve the design.For System FMEAs, the objective is to improve the design of the system. For Design FMEAs, the objective is to improve the design of the subsystem or component. For Process FMEAs, the objective is to improve the design of the manufacturing process. The other objectives for doing FMEAs are to identify and prevent safety hazards, minimize loss of product performance or performance degradation, improve test and verification plans (in the case of System or Design FMEAs), improve Process Control Plans (in the case of Process FMEAs), consider changes to the product design or manufacturing process, identify significant product or process characteristics, develop Preventive Maintenance plans for in-service machinery and equipment and develop online diagnostic techniques.

The three most common types of FMEAs are:

• System FMEA

• Design FMEA

• Process FMEA

System FMEA:

It is analysis is highest-level of an entire system, made up of various subsystems. The focus is on system-related deficiencies, including system safety and system integration, interfaces between subsystems or with other systems, interactions between subsystems or with the surrounding environment, single-point failures (where a single component failure can result in complete failure of the entire system),The focus of FMEA is also on functions and relationships that are unique to the system as a whole (i.e., do not exist at lower levels) and could cause the overall system not to work as intended, human interactions and service. Some practitioners separate out human interaction and service into their own respective FMEAs.

Design FMEA:

Analysis is at the subsystem level (made up of various components) or component level. The Focus is on product design-related deficiencies, with emphasis on improving the design, ensuring product operation is safe & reliable during the useful life of the equipment and interfaces between adjacent components. Design FMEA usually assumes the product will be manufactured according to specifications.

Process FMEA:

Analysis is at the manufacturing/assembly process level. The Focus is on manufacturing related deficiencies, with emphasis on improving the manufacturing process and to ensure that the the product is built to design requirements in a safe manner, with minimal downtime, scrap and rework. Process FMEA also emphasis on manufacturing and assembly operations, shipping, incoming parts, transporting of materials, storage, conveyors, tool maintenance, and labeling. Process FMEAs most often assume the design is sound.

The common elements of FMEA are:

1. Identify the team:

The development of FMEA should be the responsibility of cross functional or multi disciplinary team, whose members should have the necessary subject matter knowledge which also includes the knowledge of FMEA process. The team leader should have the necessary facilitation expertise and should select team member with relevant expertise and necessary authority. The team approach benefits the FMEA development process and ensure input & collaboration from all affected function areas.

2. Define the scope:

Scope establishes theboundaryofFMEA analysis. Scope is essential because it sets limits onagivenFMEA, that is, it makes it finite. It defines what is included and excluded, determined based on the type of FMEA being developed, i.e., system, subsystem, or component. BeforetheFMEA can begin,

...