What are the 4 QSIT controls?
To improve the efficiency of the inspection process, the QSIT approach focuses on the four primary subsystems: management controls, design controls, corrective and preventive actions, and production and process controls.
What is an FDA audit?
The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act. This typically involves an investigator visiting a firm’s location.
What is a for cause FDA audit?
“For Cause” inspections are performed when other information, such as product quality complaints, adverse events or data from an application or other source, indicate a potential problem with a firm’s products that warrants a more timely investigation.
Which is not type of inspection?
Explanation : General testing is not the method for inspection for defects.
What are the four types of inspection?
The four different types of inspections conducted by FDA are pre-approval inspection, routine inspection, compliance follow-up inspection, and “for cause” inspection. Each is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.
What is the problem of rehabilitation *?
Explanation: The problem of rehabilitation is Unique, For the particular structure and hence the use of common techniques for rehabilitation of various structures is limited and as far as maintenance is concerned, several new cementations materials and epoxy resigns and compounds have been developed which are highly …
What are the reasons where maintenance of structure is required?
Good maintenance includes periodical surveillance identification of local damage, deterioration and loss of durability of the structure due to environmental and other load effects. Question 47. Rehabilitation of structures may be required due to several reasons.
How many types of cracks can occur in a building?
How many types of cracks can occur in a building? Explanation: There are 2 types of cracks that can be found in buildings. Non-moving cracks are the result of shrinkage and are usually shallow. Moving cracks are caused due to excessive stress in concrete and generally are wider than 1mm.
Which maintenance is done after the defects or damage occurs in the structure?
It is preventive in nature. Activities include inspection and works, necessary to fulfill the intended function, or to sustain original standard of service. It is the maintenance done after the defects in the structure.
How do you classify maintenance of structure?
Preventive maintenance comprises of activities which are essentially required to make the structure strong and sound and capable of resisting early decay or damage. Preventive maintenance of a structure means improving the quality of construction and makes it more durable and functional.
What is the importance of maintenance?
Maintenance is an important factor in quality assurance and in some cases determines the long-term success of a company. Poorly maintained resources can cause instability and partially or completely pause the production. Malfunctioning machines or complete breakdowns can become a costly process for most companies.
What are the 2 types of cracking?
Cracking is primarily of two types – thermal cracking and catalytic cracking. Thermal cracking is further categorised into modern thermal cracking and steam cracking.