A service validation is a comprehensive examination meant to confirm that an existing, new or changed service performs as intended. However, when we talk about section 8.5.1 of the ISO 9001:2015 the difference between service/design validation and service/design verification can be confusing.
Service/design validation processes, specifically, are quality control processes that demonstrate product/service consistency, quality, and durability. They ensure that the service/design does what it is intended to do.
This aspect of quality management is particularly important in situations “where the resulting output cannot be verified by subsequent monitoring or measurement.” One example of where service/design validation is critical would be a welding process where the strength of each individual weld cannot be tested without damaging the product.
These sort of real-world necessities create quite a bind; how do you test without testing? To resolve this, service providers need to create test environments where they can perform their service process, in spaces that duplicate the workspace and conditions where the service will be performed. Once the service environment is duplicated, the tests perform a full check on each step of the service, or creation of the product: You have to perform the service on a test platform, where each step of the service can be examined, measured, and evaluated.
In order to achieve this kind of testing, providers should consider adopting practices such as:
Service validation and testing ensures that the service or product delivers the expected outcomes for the customer. In addition to controlling quality, service validation testing provides opportunities to identify ways in which services and products can be improved, and efficiencies can be found.
For more information on how Accupoint Software can help your business create and control service/product validation processes, please contact us today.
Corrective and preventive actions are important parts of a quality management system (QMS) , but sometimes it can be difficult to tell these two processes apart.
A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur. Section 8.5.2 of the ISO 9000 standard says corrective action eliminates the cause of nonconformities to prevent recurrence, and section 8.5.3 says preventive action determines and eliminates the causes of potential nonconformities to prevent occurrence. In a nutshell, one deals with what has happened and the other attempts to stop something from happening.
Many auditors recommend using separate procedures and forms to document each type of action. The standard doesn’t say this must be done, but there is a heavy implication that it should be done.
One way to understand these processes is to break down what is required for each one:
Corrective Action Process
Preventive Action Process
Both corrective and preventive actions require effective communications. In addition, both require clear documentation of actions taken and lessons learned. Documenting, controlling and communicating corrective and preventive actions ensure appropriate action is taken within a reasonable timeframe and the resulting changes are effective.
For more information on how Accupoint Software can help your organization manage the corrective and preventative action process, please contact us today.
How well do you know your supply chain? A supply chain is only strong as its weakest link. When it comes to controlling your suppliers, the better you are at understanding the entire chain and identifying weak links, the better your company will be in the long run.
The recently released API Spec Q1 9th Edition – Addendum 2 focuses on supply chain controls, specifically relating to multi-tier suppliers. As you are aware, Q1 has always required us to manage our supply chain. However, the revised requirements expand the controls to include associated (tier 2 & 3 level) suppliers that are essential for product realization.
To that end, in today’s post we will focus on a couple of tips to improve the effectiveness of your supply chain controls.
An efficient supply chain control program enables your company to reduce costs, minimize risk and satisfy customer expectations. For more information on how Accupoint Software can help your organization to improve your supply chain control program, please contact us today.
The Cost of Quality, sometimes referred to as COQ, is a measurement that sums up the costs related to the prevention and subsequent detection of defects, and the costs associated with these defects. The COQ defines the total costs of quality activities. This is money spent beyond the basic production costs to ensure that the customer receives a quality product. Let's take a look at how COQ is calculated.
The COQ includes the money spent on prevention, appraisal, and correction in a production environment. COQ can be expressed as the effort in terms of time, but it is probably best served as a calculation involving money.
The calculation itself is not complicated, and it is the addition of two compound values (which makes this the most straightforward approach to COQ):
The Cost of Control and Cost of Failure of Control each require a calculation based on their components.
Cost of Control
The Cost of Control can be defined as follows:
The Prevention Cost is the amount of money spent to prevent defects incurred during the manufacturing process. All Quality Assurance programs and efforts are included in this number, including any preventive measures taken.
The Appraisal Cost is the cost associated with all efforts focused on the detection of defects. The cost associated with Quality Control efforts are included here, including final testing and other forms of quality control.
Cost of Failure of Control
The Cost of Failure of Control is sometimes known as the Cost of Non-Conformance. This is the total cost of failure within the manufacturing process. It is broken up into Internal Failures and External Failures.
Internal Failure Cost is the direct cost associated with internally recognized defects and the costs associated with correcting them. For example, this would be the expense of fixing the discovered defects and retesting them, also known as Cost of Rework.
External Failure Cost is the cost associated with defects discovered by the customer and their correction. This Cost of Rework for external failures can include such items as product service, liability issues, and recalls.
Getting the COQ to a minimum requires careful balancing between the Cost of Control and the Cost of Failure of Control. The prevailing thought is that an increased Cost of Control will keep the Cost of Failure of Control to a minimum.
However, in most practical applications an increased Cost of Control can rapidly approach a diminishing return on investment when it is raised beyond a certain degree of effectiveness. The key is to keep the costs balanced as needed.
Quality has a price that can be calculated and studied. But the importance of maintaining the business image has many returns in repeat business and word of mouth.
For more information on how Accupoint can help your organization monitor and reduce your COQ, please contact us today.
Regardless of the industry you work in, calibration is one of those things you simply cannot overlook. Inspection equipment needs to function reliably and accurately. Calibration ensures consistency and is a requirement of quality management standards across the globe. In this week’s blog will examine four key steps to ensure that your organization is ready for your next audit.
The Calibration process does not have to be time consuming. With the right systems in place, you will be prepared for any audit, as well as have the peace of mind that comes with protecting yourself from liability. For more information on how Accupoint Software can help simplify the calibration process, contact us today.