Quality Assurance Policies and Procedures
Any company that wants to make quality a priority requires quality assurance policies and procedures to make it happen. Otherwise, quality is just a pipe dream. Specifics will depend on what products or services your business offers, and what your requirements or expectations are. However, when you rise above the specific details, quality assurance plans have many points in common, in that they describe management expectations and detail how those expectations will be met.
Quality control policies cover everything from your expectations from suppliers to who will inspect products or services and what they will look for. Procedures describe how these policies will be carried out with systematic, scheduled actions.
Quality planning, quality assurance and quality control are often used interchangeably to describe the same processes. However, as you get into the details of your plan, there are differences between them that you should know.
- Quality Requirements Definition: Also known as quality objectives, these are the minimum quality standards, which may be set by management, customers or government regulatory agencies like the FDA.
- Quality System Definition: Also known as quality management system, this includes all policies and procedures to ensure quality requirements are met, including both QA and QC.
- Quality Assurance (QA) Definition: All planned and systematic activities that are designed to ensure quality requirements are met. Briefly put, it's the way things are supposed to be done.
- Quality Control (QC) Definition: Operational activities that are used to verify quality requirements. In most cases, this refers to quality inspections.
- Quality Control Audit Definition: An independent examination of your Quality System processes to ensure they are performing as required. Internal audits are done by the company, while external audits are done by an outside agency.
As an example, suppose a client offers your company a contract, with the condition that 99.99% of your products arrive defect-free. You revise your quality management system to ensure this is the case with updated QA and QC initiatives. As part of your QA initiatives, you install new scales and laser scanners to ensure every unit is defect-free. As part of your QC efforts, you have an inspector check the calibrations on scales and scanners twice daily and open each crate to examine five random units before shipment.
Quality doesn't happen by accident. A thorough QA process begins with a documented plan, detailing the activities that will ensure that quality requirements are met. Your plan should define your objectives, specify roles and their responsibilities, define specific tasks and their schedules, as well as detail how QA relates to other plans in your organization.
Your quality plan should include:
- An introduction describing the background and need for quality assurance, outlining its scope, activities and deadlines, as well as quality requirements.
- Each job title involved in quality, including responsibilities and required qualifications.
- An organizational chart showing each role, including external vendors.
- Supplier standards required (such as ISO 9001:2015).
- List of qualified suppliers.
- Testing parameters, performance standards and acceptance criteria.
- Procedures for getting feedback, both internally and from customers.
- QC procedures.
- Audit procedures.
- Training requirements, including job-specific training.
- Policy on corrective and preventative actions and required notifications.
Quality requirements are always dictated by management, however, there are times when outside forces impose their requirements on the managers. Customers can determine your quality requirements by adding it to a contract or, more informally, by rejecting your products or services. Government agencies also impose quality requirements on companies if the industry is regulated, as pharmaceutical companies are regulated by the FDA.
Six Sigma uses an algorithm to determine quality objectives, however, this is usually better suited for large corporations. For small businesses, the process is usually less complex and requirements can be set simply by listening to dissatisfied customers, or by setting a zero-tolerance standard for defects.
Whatever your quality requirements are, they need to be defined. For companies offering high-availability services, like web servers, a common goal is 99.999% uptime, known as five-nines, or class-five, which equates to having service disruptions for only about five minutes per year.
The role of each person involved in your QA plan needs to be listed and their responsibilities detailed. For example, if you make plastic accessories using plastic injection molds, then an example of the roles and responsibilities could be:
- Mold operator: trim mold excess and check for defects after removing it from machinery.
- Floor supervisor: inspect molds for defects before sending dollies to shipping.
- Shipper: weigh cartons to ensure the unit count is correct before processing.
- Plant manager: inspect defective units to determine the cause; tally quality reports from each shift.
This is just a fragment of roles and responsibilities, which should begin from the top down, including who is responsible for reviewing and updating the quality plan, who reviews quality reports and who schedules and oversees audits.
If training is required for a specific role, this should also be stated in your quality plan. For example, employees or managers may need training on how to use specific measuring equipment.
Once you have defined the roles and responsibilities, you can then define the specific procedures, including all specific tasks and schedules. There are many templates available online with quality assurance procedures examples, which can guide you in drafting procedures, however, these aren't just specific to each industry, but can vary from one company to another depending on its size, what its quality requirements are and how it plans to meet those requirements.
A flow chart can help you visualize all of the QA procedures within your company, beginning with management approval of the plan down to the person testing or measuring products and the customer service reps getting feedback from clients. Because schedules are important in quality assurance, consider using a Gantt chart to map out each person's responsibilities over the course of a week, month or quarter.
Your procedures should have a feedback mechanism so that improvements can be made to your procedures, working toward continuous quality improvement. Having an independent auditor, ideally a consultant with expertise in your industry, will be able to analyze your procedures and get feedback from customers and employees to make recommendations on how to improve your plan.
Each QA procedure comes with specific tasks that need to be performed on a consistent basis. Simply handing someone a micrometer and telling her to measure every 10th product coming off a conveyor belt won't be enough. The tasks should be written out, in order, with the same specificity you would use to write a recipe, so that anyone reading them will know exactly what they need to do — and when.
For a small business owner who doesn't face the prospect of government audits, it may be tempting to provide oral instructions to your employees. But this won't likely be enough when your company expands, when employees leave or take vacations or when a new client asks to see your quality assurance plan.
There is nothing wrong with having employees collaborate on writing QA tasks. Even if that employee or manager doesn't need to read them every day, they will be on file should someone step in to fill that role.