Saturday, 23 May 2020

Core Tools of Quality | APQP, FMEA, MSA, SPC,PPAP

Core Tools of Quality | APQP, FMEA, MSA, SPC,PPAP

In a highly competitive environment of manufacturing, organizations are simultaneously challenged with three more equally important goals:
·         Provide high quality products meeting or exceeding customer expectations
·         Produce sustainable volume
·         Delivery on time
When properly implemented, Quality Core Tools are value-added methods and techniques that make it possible for an organization to achieve all three goals. Quality Core Tools is defined as five complementary techniques and / or methods.
Traditional five core tools are listed in order of use when designing products or processes:
             Advanced Product Quality Planning (APQP)
             Failure Mode and Effects Analysis (FMEA)
             Measurement Systems Analysis (MSA)
             Statistical Process Control (SPC)
             Product Part Approval Process (PPAP)
Quality Core Tools are used during New Product Introduction (NPI) 's Products or Processes steps and during some events such as experienced failure or engineering changes. The functionality of Quality Core Tools connects each other's input and output to each other. Unlike many people who see Tools as independent, linked tools increase their value for each other and reduce the overall workload.
How to Apply Quality Core Tools
Quality Core Tools are applied sequentially and collaboratively. Collaborative Product Process Design Collaborative Product Process Design (CPPD) illustrates both the time overlap of activities and a cross-functional communication between engineering communities.
The output of each Quality Core Tool is tied to other tools in the Product Quality Plan. The time of Quality Core Tools initial product / process development should be practical. Waiting until the last minute is not efficient and has little / no effect on quality. The creation of paperwork to "check the box" does not benefit an organization.
An example of value-added linkage can be demonstrated using the DFMEA and PFMEA relationships:
·         The design team will identify specific dimensions, physical properties and tolerances, including severity and impact on the customer. This implies a special feature. Characteristic type is dependent on DFMEA severity (critical, critical, high impact, etc.)
·         Special features are provided to the manufacturing / process engineer well before a finished design or drawing is available.
·         Time is important for this transfer; Transfer or cooperation should happen as soon as possible.
·         After being obtained by the manufacturing / process engineer, a special feature is attached to the process flow chart with a process technology.
·         Special characteristics are then transferred to the PFMEA as the failure mode for the associated process step (s).
·         The risk of process failure was analyzed as a result of which the special feature was incorrectly generated.
·         The manufacturing / process team will collaborate with the design team to discuss design for design for interchangeability or assembly (DFM / DFA).
·         The control plan is designed to detect error proof, fault proof or failure or cause with special controls.

Rahul Kashyap is the executive in a Leading Pharma Company, he author in-depth guide that teach pharma industry owner and workers way to follow, manage and grow the quality work in this Field.