So, you want to be a QA Professional
What is Quality Assurance?
Quality Assurance is the framework that ensures compliance with regulatory requirements. This is achieved through the development, implementation, and continual improvement of systems. Independent assessment provides feedback on the robustness of such systems.
Why does it exist?
Regulations and guidelines covering the conduct of product development ensure that research and development activities remain compliant. Quality Assurance functions, with their roots in the early 1970s, have slowly evolved to ensure that product development is being properly conducted. Many companies now realise that QA Professionals are well placed to advise in the development of management and business systems - demanding a wider range of skills from the QA Professional, than would initially seem necessary. This would include a thorough knowledge of the product development process, excellent communication and influencing skills, problem-solving skills, and the ability to propose practical and pragmatic solutions. What is a QA Professional? The role of the QA Professional varies from company to company but there are three main aspects that can be considered:
- Provision of advice relating to the interpretation of regulatory requirements, regulations, and quality management systems
Advice is a key aspect of a QA Professional role; they are often called upon to provide specific advice on interpreting a regulatory requirement or in how to handle a situation that may have arisen in the product development process, to ensure that it is brought back into compliance.
An important role of the QA Professional is as a facilitator of regulatory authority inspections i.e. inspections of the organisations involved in product development by external regulatory bodies.
In this capacity, the QA professional may be involved in helping prepare the organisation for the inspection, by conducting a pre-inspection audit and/or providing training on what to expect in an inspection and how to manage it. The QA professional may also be present during the inspection and act as the main company contact with the regulatory authority inspectors.
- Fundamental part of the corporate risk management framework
To fulfil financial, legal and ethical requirements organisations have a risk management and corporate governance framework.
The role of the QA function in many organisations will be an integral part of this framework, in providing periodic summaries of audit outcomes and risk statements that identify whether there are uncontrolled risks within the business.
- Conducting audits of the product development process to assure compliance with applicable regulations and standards
There are a number of types of audits that are typically performed as part of the development and manufacturing process including internal facilities, systems, and external partners’ third-party audits).
Roles and Responsibilities of a QA Professional
Quality assurance professionals play an integral role in ensuring that quality standards are met throughout the organisation. They ensure that the output meets the customer's expectations and complies with all relevant regulations.
A QA professional ensures that the company adheres to all applicable laws and regulations.
Quality Management functions might include:
- Establish the quality management system and procedures
- Ensure that the quality procedures are implemented during every step of the processes
- Plan and conduct internal quality audits
- Establish and implement the Inspection and Test Plan
- Ensure the availability of required tools, including calibrated measuring equipment
- Take appropriate corrective actions on identified problems
- Identify potential sources of error and suggest ways to eliminate them
- Perform statistical analysis of records and results
- Participate in the supplier selection process – reviewing the documents submitted by the suppliers and on-site audit
- Evaluations of suppliers' performances to support the supplier performance improvement process
Routine Administrative Functions might include:
- Maintain quality documentation
- Keep track of quality training
- Report quality findings and issues to superiors whenever necessary
- Compile quality information needed for the management review
- Participate in quality meetings
- Assist in preparing budgets.
Strategic Functions might include:
- Ensuring compliance with government regulations
- Support the development of new products
- Developing policies for the quality management system
- Evaluating the effectiveness of existing quality programmes
- Preparing reports about current trends
- Conducting research into emerging technologies
- Working with outside consultants.
Typical Skills might include:
- The ability to communicate effectively
- A good sense of orderliness and time management
- An aptitude for analysing situations and formulating solutions
- Ability to get along well with others
- Such qualities as initiative, self-confidence, assertiveness, decisiveness, and diplomacy
- Ability to think originally and flexibly
- The ability to think logically and critically.
- Curiosity and interest in learning new things
- Skills that involve choosing alternatives approaches and evaluating their relative merits
- Skills that enable anticipate future needs and devise appropriate courses of action
- Skills that organise activities efficiently and to schedule
- Ability to adjust behaviour to suit changing circumstances
- Paying close attention to small details while performing routine tasks.
Typical Methods might include:
- Cost-Benefit Analysis
- Cost of Quality (COQ)
- Control Charts
- Design of Experiments (DOE)
- Statistical Sampling
- Flow Charting
- Quality Management Methodologies (i.e. Six Sigma, CMMI, etc)
- Cause and Effect Diagrams
- Run Chart
- Scatter Diagram