by Dr. Yashashwini Reddy | Aug 8, 2025
5 Why Tool – Overview The 5 Why Tool is a simple but powerful problem-solving method used to identify the root cause of an issue by repeatedly asking “Why?” until the underlying reason is found. Typically, five iterations of “Why” are enough to reveal the true root...
by Dr. Yashashwini Reddy | May 28, 2024
Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...
