The document discusses using Process-FMEA to optimize production processes and reduce costs. It describes how Process-FMEA can identify potential failures and inefficiencies in manufacturing. A completed Process-FMEA would reveal opportunities to reduce the impact of failures and increase the likelihood errors are found before delivery. It provides examples of waste identified through Process-FMEA, such as unnecessary rechecking of parts, improper operation sequence, use of wrong tools, and inadequate maintenance. The document advises how companies can address these issues and realize the benefits of Process-FMEA, including defining production methods, tools, and cleaning/maintenance procedures to standardize processes.

1. Product-Quality ApS Products and Processes
Production Optimization with Process‐FMEA
For some companies Process‐FMEA is implemented as a tool to identify potential
failures in production, because customers demand it. The tool can also be used to
identify the "LEAN" potential to reduce waste and unnecessary work operations.
This article describes how the Process‐FMEA tool is usefully being applied to redu‐
ce production costs by optimizing processes and methods.
The primary purpose of Process‐FMEA
A successful Process‐FMEA should uncover any significant potential for mistakes by manufacturing
of a specific product or sub‐assembly. The individual error possibilities have to be clarified with
regard to the impact to the end‐user and the probability that the error is not discovered prior to
delivery to the customer.
Process‐FMEA should be conducted early in the design phase to allow production to influence
product design in order to organize a flawless and cost effective manufacturing.
What reveals a completed Process‐FMEA?
Based on a detailed assessment of each potential failure and their relative prioritization, the
opportunities to reduce the impact to the end‐user and increase the probability that the error is
discovered prior to delivery to the customer.
As a basis for identifying the various possible errors and their consequences and probabilities, it is
necessary to analyze the manufacturing process, the methods and tools used in the manufactu‐
ring of the product.
The detailed review of the manufacturing process often shows that different employees use
slightly different methods and tools ‐ including criteria for assessing the quality of the work carried
out.
This diversity from person to person is a clear indication that there is variation in the production
methods and assessment criteria with risk of variation in the quality and the extra production
costs.
Which types of waste are identified with Process‐FMEA?
The production methods and assessment criteria used can usually be reduced to one set of
methods and assessment criteria in order to reduce possible errors and eliminate redundant
operations that do not add value.
Typical waste types are:
• Parts or sub‐assemblies from sub‐suppliers are checked a second time to be sure
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2. Product-Quality ApS Products and Processes
• Improper operation sequence
• Using the wrong tool
• Dirty environments pollute the product
• Inadequate maintenance of process equipment
• “We / I have always done it this way”
How to harvest the benefits?
Re. subcontractors:
In principle, deliveries from sub‐suppliers should be error free. If the quality from sub‐suppliers is
not deemed to be sufficiently stable at an acceptable level it should be required that the sub‐sup‐
plier takes the necessary measures to meet the requirements for the quality of the delivered
items.
In this context it will be obvious to require suppliers to implement a process‐FMEA and that the
customer becomes aware of the content and the concrete actions taken by the sub‐supplier to
ensure a consistent and acceptable quality.
If it is required to carry out inspections and tests of the sub‐supplier delivered items it should be in
accordance with written instructions with objective acceptance criteria and should not be based
on each operator's assessment as this will result in variation in quality and cost.
Re. Operation Order:
It is important that the operation sequence is precisely defined and documented. During the
selection of the operation sequence it must be carefully evaluated whether there are several
alternative approaches, so the most appropriate and efficient sequence can be decided upon.
It is essential that operators with practical experience are involved in determining the operational
sequence, as this also supports that work is carried out according to the defined procedures and
methods afterwards.
Identification and determination of operation sequence and the methods used is an essential
prerequisite to implement an optimum process‐FMEA.
Re. Use of proper tools:
During determining of the operation sequence, it should also be determined what tools and
possible assistive devices that is required. If tools including required adjustments are not precisely
defined, it is likely that variation will occur in both the quality of the produced items and the
processing time consumed.
Identification and definition of tools is an essential prerequisite to implement an optimum
process‐FMEA.
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Re. Clean in the production environment:
It is important that the manufacturing environment is kept sufficiently clean so that additional
cleaning of the produced items is kept to a minimum. The usage of compressed air for cleaning is a
good example where there is a major risk that dirt is moved from one sub‐assembly to another
with extra cleaning to follow.
Re. Maintenance of process equipment:
Most process equipment requires maintenance, and it is important that these activities are
implemented according to a prescribed plan, so accidental stop are reduced to a minimum.
Breakdown of process equipment often leads to deviation from the planned process sequence,
and could result in the usage of equipment or tools that are not approved in advance for the
manufacturing of the applicable assemblies.
Adherence to strict delivery deadlines in connection with disruptions in production can sometimes
result in insufficient quality of the produced items and extra manufacturing costs.
Re. " We / I have always done it this way”:
In addition to all the technical stuff, there's also the human factors that must be handled in an
appropriate manner.
Here is the involvement, commitment, motivation and ownership crucial to ensure a uniform cost
optimal manufacturing of consistently high quality assemblies without unnecessary additional
operations and rework.
Measurement and Reporting
It is important to define targets for improvements to such important issues as cost, quality and
delivery, and define the measurement system and its reporting.
Status and progress in relation to the objectives should be visible to all who have responsibility for
and can influence on the results. Reporting should include at least the following areas and be held
up against the targets:
• Delivery performance
• Manufacturing costs – as an index
• Quality in term of internal defects and customer complaints
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Agner Hansen
Process consultant
Product‐Quality ApS
www.product‐quality.dk
agner@product‐quality.dk
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