What is the definition of Quality Assurance (QA)?

The maintenance of a desired level of quality in a product, especially by means of attention to every stage of the process.  A procedure or set of procedures intended to ensure that a product (before work is complete, as opposed to afterwards) meets specified requirements.

QA is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers. QA is applied to physical products in pre-production to verify what will be made meets specifications and requirements, and during manufacturing production runs by validating lot samples meet specified quality controls.

Quality Assurance refers to administrative and procedural activities implemented in a quality system so that requirements and goals for a product or activity will be fulfilled.   It is the systematic measurement, comparison with a standard, monitoring of processes and an associated feedback loop that confers error prevention. 

Two principles included in Quality Assurance are: “Fit for purpose", the product should be suitable for the intended purpose; and "Right first time", mistakes should be eliminated. QA includes management of the quality of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes.

CPTS

Questions Questions Questions

We want to extend our help by giving the most to our views. That's why we need your help with submitting your safety questions. 

We will choose the top 3 questions of week and post answers on our next blog.

You can submit your questions by emailing QualityAssurance@CPTSol.com. Any and all questions are welcomed.

CPTS Team

Establishing a Proper Compliance Program

Is my safety program where it needs to be?

This is a common question that a company must ask itself in regards to their safety program. Unfortunately there is not a guideline out there that is going to give you step-by-step guidance as to how to put one together. Every program built is unique to the company and the types of products they are manufacturing and/or importing. 

What a company can do to insure they are on the right track is ask themselves the right questions.  

The following 9 Questions can help you gauge if your "Compliance Program" is where it needs to be.

• Do you have a formal Statement of Management Policy?
• Does your team have knowledge of specific requirements that pertain to your product and the countries they will be sold in?
• Have internal manuals, documents, and procedures necessary for compliance been created and kept?
• What are your record keeping procedures?
• Do you have complete ownership of compliance for your vendors and/or manufactures?
•  Have you or your team had regulatory training and been certified?
• Have you formalized internal Audits and SOPs?
• How many times a year do you perform internal mock recalls, product defect situations, and contamination procedure exercises?
• Do you have a cross department safety council?

It is imperative that vendors and manufactures of consumer goods consistently evaluate the state of their program and make necessary adjustments as needed.

Have a question? Feel free to send it to QualityAssurace@CPTSol.com

CPTS Team