Materials Standards Full Framework

High-Efficiency Particulate Air (HEPA) and Ultra-Low Particulate Air (ULPA) filters are critical cleanroom components. A HEPA filter must remove at least 99.97% of airborne particles 0.3 micrometers (µm) in diameter. An ULPA filter is even more efficient, removing 99.999% of particles 0.12 µm or larger. They work via a combination of interception, impaction, and diffusion.

FMEA is a systematic, bottom-up, inductive method for identifying potential failure modes in a system, product, or process. For each failure mode, it assesses the potential effects or consequences, their severity, likelihood of occurrence, and the ability to detect them. The goal is to prioritize and mitigate high-risk failure modes before they occur.

The PDCA cycle, also known as the Deming Cycle or Shewhart Cycle, is an iterative four-step management method used for the control and continuous improvement of processes and products. It provides a simple and effective approach for solving problems and managing change, ensuring that ideas are tested on a small scale before being implemented organization-wide.

Powder coating is a dry finishing process where a thermoplastic or thermoset polymer powder is applied to a surface, typically electrostatically, and then cured under heat. The powder particles are charged, causing them to adhere to the grounded substrate. Heating melts the powder, allowing it to flow and form a continuous, durable, and high-quality finish, often superior to conventional paint.

A structured methodology for creating new products, typically involving analysis, concept development, and synthesis. It is an iterative cycle where designers research user needs, brainstorm ideas, create prototypes, and test them to refine the final product. This process ensures that the end product is both functional and meets market demands effectively before full-scale production.

Heijunka is the principle of production leveling or smoothing within the Toyota Production System. It involves averaging out the production volume and mix over a fixed period to eliminate peaks and valleys in workload. This creates a predictable and stable manufacturing environment, which is a prerequisite for implementing Just-in-Time (JIT) and standardized work effectively.

Takt time is a theoretical calculation representing the pace of customer demand (\(Available Time \div Demand\)). In contrast, cycle time is an empirical measurement of the actual time taken to complete one unit of work at a specific process step. A core principle of lean manufacturing is to ensure that cycle time is consistently less than or equal to Takt time.

Takt time is the maximum time allowed to produce a product to meet customer demand. It is calculated by dividing the net available production time by the customer demand over that period. The formula is \(T = \frac{T_a}{D}\), where T is the Takt time, Ta is the net available time, and D is the customer demand.

Just-in-Time (JIT) is a production strategy aimed at increasing efficiency and decreasing waste by receiving goods only as they are needed in the production process, thereby reducing inventory costs. This method requires precise forecasting and highly coordinated supply chains. The goal is to have the right materials, at the right place, at the right time, in the exact amount.

A foundational economic fact is that the total monetary volume of business-to-business (B2B) transactions significantly surpasses that of business-to-consumer (B2C) transactions. This is because a single finished consumer product often involves a long supply chain with multiple B2B transactions—from raw materials to manufacturing components to wholesale distribution—before the final B2C sale occurs.

Kanban, meaning "visual card" or "signboard" in Japanese, is a scheduling system integral to the Toyota Production System. It uses visual cues, typically cards, to trigger action and manage workflow. It is a "pull" system that signals the need to move materials within a manufacturing facility or from an outside supplier into the production facility.

Spin coating is a procedure for depositing uniform thin films onto flat substrates. An excess of a coating solution is placed on the substrate, which is then rotated at high speed. Centrifugal force spreads the solution, and solvent evaporation or curing solidifies the film, with the final thickness determined by viscosity, concentration, and spin speed.

The Fill Factor (FF) is a key parameter that determines the quality of a solar cell. It is the ratio of the maximum power a cell can produce (\(P_{max}\)) to the theoretical power if it were an ideal voltage and current source (\(V_{oc} \times I_{sc}\)). A higher fill factor indicates lower parasitic resistance losses and a more 'square' I-V curve.

The Toyota Production System is founded on the complete elimination of waste, categorized into 7 types, 3 main being described here: Muda (non-value-adding work), Muri (overburden), and Mura (unevenness). While Muda is the most commonly discussed, TPS recognizes that Muri and Mura are often the root causes of Muda and must be addressed first to achieve a truly lean system.

Good Manufacturing Practice (GMP) is a system of regulations and guidelines ensuring that pharmaceutical products are consistently produced and controlled according to quality standards. It covers all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff. GMP is designed to minimize the risks involved in any pharmaceutical production.