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RoHS compliance can be misleading because RoHS3 (EU) allows exemptions, ex. up to 85% lead content for high-temperature soldering alloys. [ 5 ] Therefore good companies should clearly define their level of compliance in their product main datasheets (DS); ideally, they should provide a product content sheet (PCS) with full substance declaration ...
A common definition of compliance is:'Observance of external (international and national) laws and regulations, as well as internal norms and procedures, to protect the integrity of the organization, its management and employees with the aim of preventing and controlling risks and the possible damage resulting from these compliance and ...
Manufacturing processes must be clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes must be controlled, and any changes to the process must be evaluated. Changes that affect the quality of the drug are validated as necessary.
Clearly identified sources of data that identify problems to investigate; Root cause analysis that identifies the cause of a discrepancy or deviation, and suggest corrective actions
Compliance (medicine), a patient's (or doctor's) adherence to a recommended course of treatment; Compliance (physiology), the tendency of a hollow organ to resist recoil toward its original dimensions (this is a specific usage of the mechanical meaning) Pulmonary compliance (or lung compliance), change in lung volume for applied or dynamic pressure
Malicious compliance is common in production situations in which employees and middle management are measured based on meeting certain quotas or performance projections. Examples include: Employees at a factory shipping product to customers too early so their inventory is reduced to meet a projection; [ 8 ]
Where the definition of "defense service" includes "the furnishing of assistance (including training) to foreign persons, whether in the United States or abroad in the design, development, engineering, manufacture, production, assembly, testing, repair, maintenance, modification, operation, demilitarization, destruction, processing or use of ...
Compliance training refers to the process of educating employees on laws, regulations and company policies that apply to their day-to-day job responsibilities. An organization that engages in compliance training typically hopes to accomplish several goals: (1) avoiding and detecting violations by employees that could lead to legal liability for the organization; (2) creating a more hospitable ...