Failure Mode and Effects Analysis (FMEA) and non-conformance management are two crucial components in the field of quality management and risk assessment in your IATF 16949 QMS. Iindustries like manufacturing, automotive, and aerospace. While they address different aspects of quality and risk, both play vital roles in ensuring products meet the required standards and specifications. Management Solutions Group provides expert help with internal auditing, certificate preparation.
FMEA (Failure Mode and Effects Analysis)
FMEA is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures. The goal is to identify potential problems before they occur and implement solutions to prevent them. There are several types of FMEA, including Design FMEA (DFMEA), which focuses on potential failures in product design, and Process FMEA (PFMEA), which analyzes failures in manufacturing and assembly processes.
Key elements of FMEA include:
- Identification of failure modes: Determining the ways in which a process or product might fail.
- Effects analysis: Assessing the consequences of those failures.
- Cause analysis: Identifying the causes of each failure mode.
- Risk Priority Number (RPN): Quantifying the risk associated with each failure mode, typically calculated by considering the severity, occurrence, and detection of each failure.
- Mitigation strategies: Developing actions to reduce or eliminate risks associated with failure modes.
Non-Conformance Management
Non-conformance management, on the other hand, deals with failures or deviations that have already occurred. It involves identifying, documenting, and addressing instances where products or processes fail to meet the set standards and specifications.
Key aspects of non-conformance management include:
Managing your IATF 16949 quality system during an auto strike can be challenging, but it's crucial to maintain quality standards even during such disruptions. Here are some steps to consider:
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Assess the Impact: Start by assessing the potential impact of the auto strike on your operations. Identify critical processes and resources that may be affected. This will help you prioritize your efforts.
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Communication: Maintain open and transparent communication with your employees, suppliers, and customers. Keep them informed about the situation, any potential delays, and your commitment to quality.
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Contingency Planning: Develop a contingency plan that outlines how you will continue to meet IATF 16949 requirements during the strike. This plan should include backup suppliers, alternative transportation methods, and temporary workforce solutions if needed.
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Risk Assessment: Identify potential risks to product quality during the strike. Evaluate the impact of these risks on your quality system and develop mitigation strategies. This may include additional quality inspections or process adjustments.
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Documentation: Ensure that all quality-related documentation remains up to date. This includes control plans, process flow diagrams, and risk assessments. Make sure any changes or deviations from standard procedures are well-documented.
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Supplier Management: Work closely with your suppliers to understand how the strike may affect their ability to deliver quality materials and components. Consider alternative suppliers or temporary measures if necessary.
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Employee Training: Provide additional training and guidance to your employees to maintain quality standards. Ensure they understand any changes to processes or procedures implemented during the strike.
ISO 9001
Industry Applicability: It's a universal standard suitable for all types of organizations across various industries.
Purpose: Focuses on the establishment of a quality management system that emphasizes customer satisfaction, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.
Requirements: Contains broad requirements applicable to all types of organizations and doesn't contain industry-specific criteria.
Certification: Certification is available to any organization that meets the standard's requirements.
IATF 16949
IATF 16949 is an international standard for a quality management system (QMS) specific to the automotive industry. Similar to other types of QMS certifications, the cost of IATF 16949 certification can be reduced through strategic planning and effective resource management. Here are a few strategies:
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In-House Expertise: Building internal competency and understanding of the standard can save costs associated with hiring external consultants. This can be done by providing necessary training to the staff responsible for maintaining and improving the QMS. MSG provides high quality IATF 16949 training (in person or online)
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Gap Analysis: Perform a thorough gap analysis to understand the difference between your current QMS and the IATF 16949 requirements. This can help you identify the exact areas that need to be improved, helping you avoid spending resources on less critical areas.
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Risk-Based Thinking: Implementing a strong risk management strategy is key to the successful application of IATF 16949. By identifying potential risks and taking necessary preventive actions, you can avoid costly non-conformities and corrections down the line.
The International Automotive Task Force released 3 new sanctioned interpretations in May 2022 that became effective in June. (SI 23-25). #23 was related to Product and Process Conformance and #24 & #25 were related to Control Plans.#23 is not really a new requirement, but explicitly states that conformance to material requirements are also part of the organizations requirement to ensure conformance including any processes or products that are outsourced. The rationale for this includes the increasing material regulatory compliance importance.
#24 relates to Annex A: A.1 for Phases of the Control Plans: a summary of control information may be acceptable with direct references or linkages to the system that manages the detailed process control information, FOR highly automated processes.
#25 relates to Annex A: A.2 Elements of a control plan, Point e) Part Numbers “Or common control plan designation”. This would be applicable to common control plans used for multiple part numbers.
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- There are additional supporting “Reference Manuals” for IATF including
- Measurement System Analysis (MSA)
- Statistical Process Control (SPC)
- Failure Modes and Effects Analysis (FMEA)
- Production Part Approval Process (PPAP)
While the changes are more evolutionary than revolutionary (Except for the new FMEA process), it would be a great time to train newer quality, engineering and production staff and / or hold a refresher course. The new FMEA process will require additional training for auditors and practitioners.
IATF 16949 Background:
IATF 16949, PPAP, and Customer Requirements state that you must perform APQP & FMEA, but since they are reference documents you have more discretion as to “How” you implement the processes. The requirement is that APQP & FMEA processes are effectively implemented – Customer and Company metrics can provide information of Customer Satisfaction, efficiency and effectiveness.IATF 16949: 2016 requires that Engineering and Quality staff be competent within their areas of responsibility. Additionally the Internal auditors that audit the core tools must also be competent. This may be a good time to refresh or train your staff.
This is an excerpt from the Online IATF 16949 Internal Auditor Training Course. Listen to Brandon Kerkstra describe this extensive online course.
 Module 1 – Introduction and the Automotive Process Approach with Risk Based ThinkingModule 2 – IATF 16949: 2016 Requirements and Objective Evidence (Including Process Design)Module 3 – Product Design Requirements (Will Not be applicable to all facilities and organizations)Module 4 – Auditing the Core ToolsModule 5 – Auditing Customer SpecificsModule 6 – Auditing Basics – ISO 19011, including: understanding how to plan, conduct, report, and close out audit findings, sampling, interviewing etc… |
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Note: this covers the sanctioned interpretations though January 19, 2019, the additional 8 will be covered in a new review.
We are going to review each of the current 15 sanctioned interpretations and discuss what they will mean to your QMS. There may be items you have already addressed, there also may be items that you have not formally addressed, but there are standard practices that are done in your organization that address these.
To listen to Brandon Kerkstra's introduction click the "play" icon.
If you are interested in viewing all of the IATF courses, click here to go to Ingentius.
IATF Requirements:- Supplier audits must be part of the supplier management approach (Section 8.4.2.4.1)
- Supplier audits must be a part of an organization’s supplier development process –
- 8.4.2.5 Supplier Development. The organization shall determine the priority, type, extent, and timing of required supplier development actions for its active suppliers. Determination inputs shall include but are not limited to the following (8.4.2.5 b) - second-party audit findings (see Section 8.4.2.4.1);
- Supplier selection shall be based on ”An evaluation of the supplier’s quality management system” (8.4.1.2) – audit is not explicitly required, but could meet this requirement.
- Supplier auditors must be training and qualified to very specific requirements (7.2.4) (Essentially the same as internal auditors with the additional requirement of understanding the applicable manufacturing processes to be audited)
- These qualifications must be maintained, including changes to any of the core tools
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