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:
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• Service validation tests designed and carried out by the people who haven’t been involved in the design and development process.
• The criteria for passing/failing of a test should be documented in an SDP before any testing.
• Each test environment should be restored to its original state before starting a new test.
• A risk-based testing approach should be adopted to reduce the risk to the service or product. This means stress testing until failure, in order to record and report failure thresholds.
• Service validation and testing need to create, catalog and maintain a library of test models, cases, and data which can be re-used. This is important for being able to re-perform service/product validation during the service lifetime.
• The creation of a quality management system that ensures consistency across all platform and personnel, in order to ensure test conditions can be adequately recreated.

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

• Locate and document the root cause of the nonconformity.
• Audit the system to ensure no other nonconformity could occur. (impact analysis)
• Analyze the effect the nonconformity may have had on a product or service before it was discovered.
• Which may require taking action by either recalling the product, notifying the customer, downgrading or scrapping product.
• Establish thorough follow-up to ensure the correction is effective and recurrence has been prevented.

Preventive Action Process

• Take proactive steps to detect a potential nonconformity before it can occur.
• Use system analysis to create built-in safeguards and process changes to prevent nonconformance.
• Example, use of a failure mode and risk analysis to identify potential deficiencies and create priorities for improvement.

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.

For consumers, product purchase verification is simple. It means opening a package or trying a product to see that what you paid for is what you get. For businesses, the process is much different. Product purchase verification is actually serious business that requires full-time professionals with engineering degrees. The concept is important to consider both for compliance and professional reasons.

The most important component of purchased product verification is actually certifying that the product was delivered. Even a medium sized company has many good coming and going across different warehouses and locations. It is impossible for one person to physically verify every delivery. For that reason, logging every delivery in an accounting or compliance system is crucial. After the delivery is logged, it can be tracked and utilized for production or distribution. Product purchase verification also sets off the accounts payable timeline.

The next most important factor is that the product delivered meets the quality standard expected. Products that have a chemical composition such as LNG, diesel or heating oil require an engineer or chemist to verify that the product is correct. They then log the information into a software or compliance management solution to confirm the quality information.

Lastly, product purchase verification is crucial for safety. The delivered product should be stored and contained in a package that prevents it from harming workers. Additionally, it should not be placed next to any other material that could produce a strong combustible reaction. Again, professional engineers or compliance professionals must work on this process to assure nobody is injured. They log information into an online system and carefully monitor the placement of all products.

Accupoint Software is a leading provider of compliance management tools for the petroleum industry. For more information on solutions to manage purchased product verification,  please contact us today.

Quality management for service supply organizations in the petroleum industry is ever-changing due to increasing demands from customers to adopt new standards and avoid future catastrophes.  The API Spec Q2 standard outlines a risk-based quality management system as compared to a processed-based management system. API Spec Q2 is now fully implemented and accepting applications for certification from organizations around the world. This certification is rapidly becoming a requirement for many service supply organizations and will expand to become a global mandate in the near future.

Requirements

Applicants must have procedures in place to address dozens of key QMS elements. These pertain to risk assessment, contingency planning, management of change, service-related product, process design, supply chain controls, and service quality planning. Other requirements involve preventive maintenance, inspection and test and the competency of personnel. According to John Modine, API’s vice president of Global Industry Services, “Any drilling service provider who is in compliance with the requirements can now receive API Spec Q2 certification.”

SAM API Q2 Solution

Accupoint’s web-based solution is an easy-to-use API Spec Q2 management system designed to ensure that compliance requirements are managed and monitored consistently. Using the latest technology and industry best practices, SAM™ streamlines the process and ensures an easy integration into this new standard.  In addition, the solution is accessible from any web enabled device and connects multiple locations with real-time communications and up-to-date records and information.

The SAM™ platform simplifies management of the requirements of API Spec Q2 standard, allowing for easy integration and compliance. It addresses all the key required components including;

• Project Management
• Service Quality Planning
• Contract Review
• Risk Assessment
• Training & Competency
• Preventive Maintenance, Inspection & Test
• Management of Change
• Supply Chain Management

Obtaining API Q2 certification is just the first step. Ensuring your quality management system stays compliant is the next. With 43 integrated modules and 85 built-in reports, administration and surveillance of the API Spec Q2 requirements is ensured. Contact us for any additional questions you may have on how to implement and maintain an API Spec Q2 quality Management program.

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.

1. Educate your employees- Education includes topics such as proper use, care, maintenance, and of course, procedures. In order to ensure that you properly follow all procedures, continual training is vital. Make procedures visible, frequently remind staff through email alerts or in person sessions, the importance of the calibration process, signs to look for, and what to do when you suspect equipment is out of calibration.
2. Documentation is your friend - Good record-keeping practices benefit you in two ways: you will be prepared for any audits that may come your way, as well as reminding you when calibration dates are coming up. Proper documentation should include any information pertinent to your equipment. This includes, but is not limited to, accidents, malfunctions, part replacements, servicing, etc. A good set of records should be easy to reference and can save you time and money in the long run. 
3. Maintain all equipment - While it may be tempting to continue to use equipment past required calibration intervals, this should be avoided at all costs. These intervals and any calibration earmarks exist for a reason. Operating past these deadlines opens up unnecessary liability.
4. Invest in calibration management software - The right software can handle all of the above steps, except for actually calibrating the equipment.  Choose a system that uses best industry practices, digitally maintains all applicable records, and sends reminders on upcoming calibration requirements.

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.