What is Quality Assurance

In this blog I would like to present what is quality assurance.
Before understanding the concept of quality assurance let us explore the generic buying process of any customer.
Every  customer would like to purchase any of goods or article. In this case a customer is having certain, clear or defined expectations that it would fulfill his/ her requirements.
Say for example if our customer would like to purchase smartphone. in this case the expectation is communication and device must be useful for multi purpose.
As we all experience the uses of smartphone in current World and the smart phone is a device used  for the communication, socializing, financial transactions, gaming knowledge, taking photographs, vedios, sharing and also caring with greatest reliable durability.
if I convert the paragraph into quality terminology these requirements or expectations will be known as specifications.
As a whole if I group the above paragraph into two different specifications one is the device must be useful for multi purpose majorly communication and durability.
now if you see the terminology reliability is the major concern of any customer because he is going to spend huge amount of money on the device.
now the customer approaches a salesperson for eCommerce website we will look into how should I trust the performance of the device.
And the question comes who is going to provide the reliability are certificate of it performance to the customer.
it is none other than Quality Assurance if you see any product it will be wearing a label QC tested are a guarantee or warranty information.
simply the salesperson will show the label or tag it is guaranteed are it has some warranty are it is having some certification therefore the customer is not trusting the sales person but the document ((Bill/Receipt) or the certificate or the information card are the guarantee card or the warranty card.
now the question comes who is going to provide this reliability certificate or warranty guarantee cards. Yes, he is none other than the person who is working in quality assurance in the organisation.
therefore Quality Assurance is having authorisation to provide the information card on guarantee our warranty on the performance of the goods are articles that are being purchased by a customer.
Now the question comes is that simple to provide guarantee and warranty card to Quality Assurance guy?.
Yes this quality assurance that I will trust the other stakeholders in the company like quality control production where house purchase and his component suppliers.
the bundle of this confidence or trust will make quality assurance personal to provide certificate on its performance or warranty or guarantee of the device or goods or articles.
from a paragraph there are few words that we must remember that requirements dictations specifications are the part of customer with which is going to satisfy our fulfill his needs.
therefore the ultimate goal of any business is to satisfy the requirements are needs of the customer with ultimate performance of the services are goods provided to the customer.
Quality Assurance plays a vital role in answering the queries that would be raised by the customer Management for regulatory authorities are national governing bodies.
Now let us see some definitions.
Confidence is a belief that future events will occur in line with ones expectations, based on familiarity and prior experience. 
Trust means conferring responsibility to and relying on a person-like entity, where you place yourself in a vulnerable position
Quality Assurance
a positive declaration intended to give confidence; a promise.
confidence or certainty in one's own abilities
Quality
The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs, therefore quality must be built in property of any product or service.
Bottom line
For any business meeting customer expectations is very much needed to survive in this competitive world.



Comments

Post a Comment

Popular posts from this blog

FDA describes detailed CAPA Procedure in Warning Letter

An FDA Warning Letter is a formal communication from the US Food and Drug Administration (FDA) notifying a company or individual of regulatory violations. These typically describe observations made during an inspection and list violations found (referencing the specific sections of the FD&C Act, the Code of Federal Regulations (CFR), and other applicable laws as appropriate). In addition, specific measures are listed that the recipient must take to remedy the violations. It does not go into great detail, especially not with regard to instructions on the desired procedure. In a Warning Letter issued to Sun Pharmaceutical Industries Limited (India) at the beginning of July, this is now different. It describes in great detail what the FDA considers to be appropriate CAPA measures in a specific case. What happened? The company was criticised for not adequately cleaning and maintaining the equipment used to manufacture drug products. According to the company's response, a defective ...
Read more

FDA Warning Letter Missing Ongoing Stability Studies for APIs

Company Antaria Pty. Ltd, Australia Synopsis  1.Inadequate Investigation  2. Own Analytal Methods used but proved to equivalent to USP methods 3.Annual Stability missed 1.Failure to adequately investigate and document out-of-specification results and implement appropriate corrective actions . Your firm manufactures API (b)(4) USP, labeled in part to be the active ingredient used in (b)(4). You failed to adequately investigate out-of-specification (OOS) test results. Specifically, your firm lacked adequate investigations and corrective actions for numerous OOS results obtained during laboratory testing of your API, including assay and loss on ignition (LOI) testing. The root causes were not clearly defined nor adequately documented, and lots with OOS results were released by your quality unit (QU). In your response, you state that staff turnover and insufficient staff training attributes to the lack of competency in good laboratory practices . Additionally, you state that you...
Read more

Understand ICH Q7

What is meant by ‘quality unit(s) independent from production The intent of the term ‘independent’ is to prevent any conflict of interest and ensure unbiased decision-making regarding quality-related decisions in the organization structure. The person in the quality unit who is responsible for final decision-making (e.g., batch release decision) should not have responsibilities for production activities [ICH Q7, 2.13]. Does ICH Q7 expect that the quality unit performs API release testing While the quality unit has responsibility for the release of the API, which includes oversight of the testing and results, ICH Q7 does not prescribe specifically who performs testing. ‘Quality control’ in the ICH Q7 Glossary [ICH Q7, 20] refers to the activities, not the organisational structure. For examples of quality responsibility related to testing and release, refer to [ICH Q7, 2.13, 2.22, and 11.12]. Appropriate laboratory controls should be followed [ICH Q7, 11.10, 16.10] regardless of who ...
Read more