As I promised in the previous post “what is a Quality Audit? And why it is needed?” I’m going to list out the types of quality audits and how they are performed in little bit detail. If you have not gone through previous post, I would suggest you to take a minute and go through it. Coming to the types, it has been generalized that there are five common types of audits. These are illustrated in the following diagram.
As name suggests this is performed internally in a pharmaceutical and medical device industries. It is a commonly employed practice to assess or estimate the status of quality systems in the industries (pharmaceutical and medical device). It consists of a methodical review. These audits are performed by visits to the locations where development, manufacturing, testing, warehousing, and other associated operations are performed. The audits also include visits to the supporting areas, such as planning, product-complaint handling, training, purchasing, and so on.
Consider a big pharmaceutical company and it has lot of sales in different parts of the world. To minimize the cost of production, they outscore production to different companies around the world by setting quality standards. In other words they give contracts to small companies. From this example you can deduce the major difference between contractor and internal audits. That is contractor audits are performed at facilities and on systems operated by another company. In executing a contractor audit, one is not only evaluating the operations within that company against external standards, but also against quality requirements that have been agreed upon via a contract. Contractor audits can focus on many different functions including manufacturing, packaging, testing, calibration, product-development functions, distribution, and installation services. It is expected that contract situations between different divisions within a company will be audited in the same manner as external contractors.
Note: All these audits have explained based on pharmaceutical and medical device industries keeping in mind.
Remaining types will be discussed in the next post. Thank you. Stay tuned! By subscribing to news feed.