- April 19, 2022
- Posted by: PQSadmin_new
- Category: ISO Certification
Core quality tools have become one of the foundations for implementing and maintaining any IATF 16949-based QMS (Quality Management System). AIAG (Automotive Industry Action Group) has developed a set of methodologies and techniques in collaboration with automotive manufacturers to improve the efficiency & effectiveness of IATF 16949-based QMS by providing high-quality products, producing the required quantities, and on time delivery.
Other industries took notice of the tools that are being utilized, and some of these tools have since been adopted by the aerospace, medical, and other industries. If you have any doubts about the importance of these five core quality tools, keep in mind that even internal auditors must have at least a basic understanding of them.
What are the five core tools?
- Advanced Product Quality Planning (APQP)
- Failure Mode and Effects Analysis (FMEA)
- Measurement Systems Analysis (MSA)
- Statistical Process Control (SPC)
- Product Part Approval Process (PPAP)
Advanced Product Quality Planning (APQP) is a method used by manufacturers to demonstrate that they can design and manufacture a product that meets the needs of the customer. The main goals of APQP are effective communication, timely task completion, quality issue reduction, and quality-related risk minimization during product launch. Pre-planning or input, planning and definition, product and process design and development, product and process validation, and finally, feedback assessment and corrective actions are the steps involved in APQP.
Failure Mode and Effects Analysis (FMEA) is a technique for identifying and prioritizing various failure modes and their consequences. The risk represents a link between failure modes, their potential consequences, and the causes of failure. FMEA has proven to be an effective risk assessment tool in the manufacturing and design processes, and some modifications and variations in the methodology have been made to better suit specific processes; these FMEA variants are known as “design and process FMEA” (DFEMA and PFMEA). The following are the key terms in FMEA:
- Severity – indicates the severity of a failure mode’s potential consequences.
- Occurrence – depicts the likelihood of a specific failure mode occurring. It can be based on the organization’s existing data, as well as the experience or estimates of the people involved in the assessment.
- Detection – depicts the ease with which the failure mode can be identified after it has occurred. For example, flaws in the product’s physical appearance are easy to spot, but a circuit board malfunction or defect can appear after the product has been delivered to the customer.
The organization assigns a risk priority number (RPN) to each failure mode based on severity, occurrence, and detection, and these set priorities are used for taking actions to mitigate risks.
Measurement Systems Analysis (MSA) is a collection of statistical analyses and methods for assessing measurement process variability. It’s mostly used to see if an evaluation or measuring methodology is suitable for a specific part characteristic. MSA considers five distinct parameters: bias, linearity, stability, repeatability, and reproducibility, with “Percent Error to Tolerance” and “Percent Error to Variation” as acceptance criteria.
Statistical Process Control (SPC) is a quality control statistical method that is primarily used to monitor and control processes. SPC can be used in any process where the output can be measured, with the primary goal of producing as many conforming products as possible with the least amount of waste due to nonconformities. Normal distribution and control charts are SPC’s two main weapons.
The normal distribution is a bell-shaped curve that directly relates to the frequency of occurrence of the characteristic being measured, with most occurrences falling in the middle, and fewer at the higher and lower ends (forming the “bell” shape).
Control charts are the most popular, and arguably the most effective tool of SPC. The purpose of the chart is to indicate trends or patterns that occur in the process and to enable the organization to affect the patterns and decrease waste and nonconformities.
Product Part Approval Process (PPAP) is a method of proving that a manufactured part meets the design intent and initial requirements and that the manufacturing process can consistently produce such parts. The result of PPAP is a set of documents known as the “PPAP package,” which must be approved by both the supplier and the customer to show that the client’s requirements have been understood, the product meets those requirements, and the manufacturing process is capable of producing the conforming product.
A PPAP is similar to a work plan or strategy in that it confirms how each PPAP element is satisfied through direct negotiation between the customer and supplier.
Why use core quality tools?
These core tools are designed to deliver high-quality products that meet or exceed customer expectations, produce a consistent volume, and deliver on time. According to the data gathered for the previous ISO TS 16949, many nonconformities were caused by the poor (or nonexistent) implementation of core tools. The organization must become familiar with the core tools and apply them on a daily basis in order to implement IATF 16949. This will ensure not only standard compliance but also product quality and continuous improvement.
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