Length: 2 Days
PFMEA ( Process Failure Mode Effects Analysis) focuses on processes.
PFMEA is a qualitative tool, a living document, that zooms into current processes to identify improvement points. PFMEA is part of the larger failure mode and effects analysis (FMEA) family.
A PFMEA will break down on organization’s maintenance process into its individual steps and methodically examine them for potential risks or failures.
One of the key benefits of PFMEA is flexibility. A PFMEA approach can be used in many ways. Some of the more common scenarios, include:
- When an existing process is slated for improvements
- When there’s a new way of implementing an existing process
- During the execution of the process for quality control measures
- When relocating a process to a new facility
- Before control plans are developed for a new or modified process
- When a new process, method, requirements, or technology is introduced
Organizations also use PFMEA when there is a current process exposed to a new environment or change in location (no physical change made to process).
The effects of a failure are focused on impacts to the processes, subsequent operations and possibly customer impact. Many effects could be possible for any one failure mode. All effects should appear in the same cell next to the corresponding failure mode. It is also important to note that there may be more than one customer; both internal and external customers may be affected.
The severity of each effect is selected based on both Process Effects as well as Design Effects. The severity ranking is typically between 1 through 10.
PFMEAs should never be filled out by only one person, it needs to be filled out by the team that owns the process. Buy-in from every team member is required to prevent the PFMEA from becoming an afterthought.
It is a good idea to spend the time to identify which process really needs an FMEA. Conducting too many PFMEAs on non-critical processes will consume resources without returns.
PFMEA is used in the manufacturing industry, aerospace sector, automotive industry, and defense industries. It’s also used to reduce risk and improve quality by identifying failures in a process—which can be applicable to many more industries.
Businesses of all types use PFMEA to maintain safety, quality, and performance standards. In fact, it’s one of the most widely used tools in the quality management industry. PFMEA can be used to analyze processes such as:
- Production lines
- Manufacturing processes
- Materials handling equipment (lifts, conveyors)
PFMEA Training Course by Tonex
PFMEA training, Process FMEA training course will cover the theory, logic, and techniques behind the process failure mode and effect analysis procedure.
Tonex PFMEA training course will teach you what each of the above variable means and they are measured by PFMEA. Also Tonex PFMEA seminar will help you learn a general template for this procedure, while also teach you how to tailor it based on your product/process specifications. Students will bring their own examples and using Tonex PFMEA framework and tools, they are able to analyze their process and measure the failures and risks while in the class.
During this two-day hands-on seminar, trainees will also learn about the PFMEA applications in the following matters:
- Problem-solving process
- Daily improvement
- Creating value-added PFMEAs in a shorter time
- Identifying operator errors in PFMEA
When using in problem-solving PFMEA demonstrates multiple similarities with Eight Disciplines of Problem Solving (8D) method. During the Tonex PFMEA training course, we will explain the relationship between PFMEA and 8D methods and will teach you when to use which.
As mentioned above, PFMEA is used on early stages for initial improvements. However, Tonex PFMEA seminar will train you how to put this practice into work for your day-to-day improvements also. Once it is used effectively by a Cross Functional Team (CFT), PFMEA can continue its service to Kaizen or Continuous Improvement teams.
Another benefit of participating in Tonex PFMEA training course is that you will learn the techniques to dramatically shorten your PFMEA Development activities. Such action occurs through reviewing all the available data and identifying areas in which the information is new, changed, or affected by the time and environment. During the Tonex PFMEA workshop, we will train you to capture known and brainstormed failure modes and causes in a user-friendly worksheet.
Those who have the experiencing of developing PFMEAs can tell you that it is not an easy task. A comprehensive PFMEA Development is crucial in order to gain value from practice, while it should not be an excessive time intensive procedure. The Tonex PFMEA seminar will provide you the techniques which help you create a comprehensive and effective PFMEA at a reasonable amount of time. We will teach you how to collect and document all the brainstormed and received information into a database so that if the same problem happens, there won’t be any need to have a discussion and brainstorming session again. Through this useful technique, failure modes and causes can be reviewed fast to develop a proper PFMEA.
Learn about Four Common Classes of FMEA:
- System FMEA: Focuses on how interactions among systems might fail.
- Design FMEA: Focuses on how product design might fail.
- Process FMEA: Focuses on how processes that make the product might fail.
- Machinery FMEA: Focuses on how machinery that perform processes might fail.
- Process Failure Mode & Effects Analysis (PFMEA) Operating Scope :
- Processes involved in determining of final product characteristics.
Trainees Will Also Learn:
- How to incorporate PFMEA into new product development process
- How to impress customer and meet organization requirements
- Relationships between PFD, PFMEA, Control Plan, SOP
- Relationship between PFMEA and 8D
Based on the effects of failure mode, the attendees will identify the severity of the failure mode by using severity-ranking chart:
- PFMEA Input for Preparation
- Process Flow Diagram
- Drawing & DFMEA
- AIAG FMEA manual 4th edition as guideline standard for PFMEA preparation.
- PFMEA check sheet for carrying out the PFMEA.
- Historical data (e.g. Customer Return / Warranty Rejection, In-house Rejection, Process Capability Report etc)
- Quality and Reliability History
- Occurrence matrix and feedback ratio
- Approach for making PFMEA.
- Identify the potential failure mode of each process and find out the effect of each potential failure mode at the current operation, next operation(s) and at customer end.
- Lesson learned
- PFMEA Output
- Detection Rating
- Occurrence Rating
- Severity Rating
- RPN Rating
- Prevention Method
- Detection Method
- Recommended action, as applicable
- Risk Evaluation
- Risk priority number (RPN): Risk Priority number is Severity multiplies by frequency and detection. The use of an RPN threshold is NOT a recommended practice for determining the need for actions.
- Setting of RPN target
- RPN target will be fixed based on the Severity ranking for initiating action on failure mode / causes. The following RPN Target will be used during PFMEA unless otherwise specified by the customer.
Example approaches to reduce S,O, and D:
- To reduce Severity (S) ranking: Only a design or process revision can bring about a reduction in the severity ranking.
- To reduce Occurrence (O) ranking: To reduce occurrence, process and design revisions may be required. A reduction in the occurrence ranking can be effected by removing or controlling one or more of the causes of the failure mode through a product or process design revision.
- To reduce Detection (D) ranking: The preferred method is the use of error/mistake A redesign of the detection methodology may result in a reduction of the detection ranking.
Examples of Weld Process Failure Modes
- System (Welding Line)
- Robot Failure
- Loss of Incoming Water
- No Signal to Weld
- Subsystem (Weld Gun)
- Cracked Jaw
- Failed Servo Motor
- Failed Shunt
- Component (Servo Motor)
- Loss of Position
- Premature Seal Failure
- Cost of Defects
- Risk of Defects
- Bracketing Strategies
- Protecting On-Time Delivery
- Cost of Stopping Production
- Cost of Recall Campaigns
- Benefits of Traceability
- Prioritization of Risk
Alternative strategies exist for the mitigation of risk, for example:
- High Risk Priority Numbers
- High Severity Risks (regardless of RPN)
- High Design Risks (Severity x Occurrence)
- Other Alternatives (S,O,D) and (S,D)
Tonex Process FMEA training includes many in-class activities including hands on exercises, case studies and workshops. During the Process FMEA workshops, students bring in their own design work and issues and through our coaching, develop their own Process FMEA Failure Mode and Effects Analysis (PFMEA).
Learn about the framework, tools and procedures:
- Potential FMEA Reference Manual is the authoritative reference.
- Severity scores of 9 or 10 must be used for safety related risks.
- Occurrence ranks how often each cause is likely to result in failure.
- It is appropriate to focus on high severity items first.
- Credit for preventive actions shows up in the frequency of occurrence.
- Risk Priority Numbers provides a rank order to risks and action items.
- An effective approach is to continually focus on the top five concerns.
- Process FMEA should result in tangible improvement to process
Tonex PFMEA training is a one-day course designed for:
- Cross functional team members
- Internal auditors
- Quality team members
- New product development managers
- R&D personnel
- All individuals involved in preparing, reviewing, and maintaining PFMEAs.
Upon completion of this seminar, attendees are able to:
- Define PFMEA
- Explain the whole procedure of PFMEA, step by step
- Brainstorm potential failure modes
- Evaluate risk of failure
- Define and evaluate four elements of severity, occurrence, detection, RPN
- Apply PFMEA in problem solving
- Use PFMEA in daily improvements
- Create value-added PFMEAs in half of the time
- Address operator errors in PFMEA
- Understand and discuss the similarities and differences between PFMEA and 8D
- Identify where to use 8D and PFMEA to solve problems
- Develop a thorough PFMEA as quickly as possible
- Document all the PFMEA information related to each incident
- Use the prepared database to run PFMEA for a repeating problem without re-brainstorming and re-discussion
- Apply mistake proofing techniques
Overview of PFMEA
- PFMEA definition
- Elements of PFMEA
- Principals of PFMEA
- PFMEA team members
- What are S/O/D factors and how they are related to RPN?
- Applications of PFMEA output:
- Process redesign/leaning
- Control Plan
- Out-of-Control Action Plan (OCAP)
- Identifying potential failure modes, before occurring
- Manufacturing and assembly failures detection
- Key process variables detection to control the potential failure causes
- Prioritizing the potential failures
- Establishing corrective/preventive actions to avoid failures
- Identifying critical process properties
- Feeding the process control plan
PFMEA Vs. 8D
- What is 8D?
- Similarities between 8D and PFMEA
- Differences of 8D and PFMEA
- When to use PFMEA and when 8D?
Prior PFMEA Requirements
- Building an effective team
- Collect proper people
- Organize the people effectively
- Assign a separate team to each process
- Agreeing on a ranking system
- Defining the customer needs and expectations
- Define the process requirements and standards
- Mapping the baseline process with a flow chart
- Creating the team
- Mapping the process
- S/O/D ranking and RPN calculation
- Action plans to reduce the RPN
- Actions to resolution
- Implementing control systems
- Adjusting RPNs
Mapping the Process
- Selecting on the process
- Defining the scope of the process, the start and the end points
- Agreeing on the level of detail usage
- Determining the sequence and the steps of the process
- Determining the key components of the process
- Identifying the main potential failure modes
- Analyzing the results
- Documenting the data for each step of the process
Developing the Action Plan
- When action plan is needed?
- Identifying the difference between the current and the desired situation
- Identifying the ways to eliminate or reduce the failures
- Eliminating unnecessary steps and those that don’t add value to the output
- Assess the effectiveness of the design modification on the S/O/D ratio
- Document all the data
- Re-evaluate the S/O/D and RPN values
PFMEA as Part of ISO9001
- Advanced Product Quality Planning & Control Plan
- Measurement System Analysis
- Process Failure Mode and Effects Analysis
- Statistical Process Control
- Quality System Analysis
- Production Part Approval Process
- Tooling and
TONEX PFMEA Workshop and Case Studies
- Form a cross-functional team
- Select a team leader
- Select a process
- Define the scope, goals, and timeline of completing the PFMEA
- Develop a detailed process map
- Transfer the map to a PFMEA template
- Assign S/O/D score
- Calculate the RPN
- Complete a Responsible, Accountable, Consulted, and Informed (RACI) chart for the corrective actions.
- Track changes in the process, design, and other key components
- Analyze the results
- Develop a proper action plan
Process FMEA Training, PFMEA Training