FMEA

How BPA’s Software Meets IATF 16949 Requirements for Automotive Industries

IATF 16949:2016 is an independent QMS standard, dedicated to the automotive sector, that is fully aligned with the requirements of ISO 9001:2015.

IATF 16949 includes specific requirements and core tools from the automotive industry, like:

  • Advanced Product Quality Planning (APQP)
  • Failure Mode and Effects Analysis (FMEA)

APQP ensures the voice of the customer is clearly understood, translated into requirements, technical specifications and special characteristics. APQP is typically used when introducing a new product, process or qualifying, evaluating new suppliers. From design to production, the APQP tracking sheet makes sure you go through each step and meet all needed requirements.

APQP

Screen Capture of BPA Quality & Risk Management, APQP example.

BPA’s software brings simple collaborative tools to track APQP projects with their milestones, related question sets, compliance and documents. Workflow rules ensure the right persons are automatically alerted to plan actions or mitigate risks.

Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process. Discovering a failure early in product development using FMEA improves the product design and lowers cost. Important FMEA steps are to identify failure modes and assess their severity, identify causes and probability of occurrence, set up preventive process controls (detection). As a result, FMEA highlights Risk Priority Numbers (RPN) for each identified failure mode. Actions will be taken to mitigate high risks.

FMEA

Screen Capture of BPA Quality & Risk Management, FMEA example.

FMEA is a collaborative process that can be easily tracked with BPA’s software, replacing inefficient spreadsheets.

BPA Quality & Risk Management is leveraged by the benefits of Microsoft Office 365 technologies.

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Software Validation

Software Validation with BPA Quality & Risk Management

Software validation is an essential, mandatory process for any life sciences company seeking to deploy enterprise software to manage any cGxP process or global predicate rule requirement. The ultimate goal of software validation is to help ensure confidence that systems are installed and functioning according to their intended use and that there is documented evidence to confirm it. Validation requires rigorous procedures to provide governance for the overall process and must be implemented and executed by those who have the requisite training to carry out such procedures. Validation is also governed by regulatory bodies including the U.S. Food and Drug Administration, EU Annex 11, ISPE GAMP 5, IEEE 1012:2016, Pharmaceutical Inspection Convention/Co-Operation Scheme (PIC/S Guidance) and many others which provide regulatory mandates, procedures and best practices to support computer systems validation for today’s regulated systems environments.

Software Validation

In the past, validation has been conducted primarily through manual, paper-based processes. As with any such process, it could be sometimes error-prone, inefficient and sometimes ineffective. Cloud-based computing and the advent of mobile technologies have changed the paradigm of validation yet, the mandate and principles of validation still endure. One must still confirm the installation or provisioning of validated systems to ensure that they are provisioned in a consistent, repeatable manner. One must also confirm the operation of such systems to ensure that each stated requirement is rigorously tested in a manner that will withstand global regulatory scrutiny. And finally, performance testing on validated systems in the cloud is critical to the overall adoption and success of the system. All cloud providers are not created equal, thus performance testing must be conducted with either simulated or live loads to ensure optimal performance under production system environment conditions.

All validation testing must be conducted in the context of a risk assessment for the system. The assessment of risk drives the level of validation due diligence required for any given system A formal risk assessment highlighting controls and mitigation strategies as well as a timetable for periodic assessment is in keeping with ISPE GAMP 5 requirements as well as many global mandates for validation.

The elephant in the room facing many validation engineers is that of cybersecurity. The challenge for validation engineers is how to ensure readiness and protect validated systems against the threat of cybersecurity. Our software validation Partner – OnShore Technology Group – uniquely inspired the term “Cybersecurity Qualification” or “CyQ”. In addition to conducting IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification), OnShore Technology Group recommend a CyQ (Cybersecurity Qualification) to address the ability to identify, protect, detect, respond, and recover from cyber events from validated systems.

To support the rigorous requirements for the validation of BPA Quality & Risk Management software, OnShore has developed a unique service offering known as CloudMaster 365 Validation Accelerator For BPA Solutions. A Validation Accelerator is a service offering consisting of Enterprise Validation Management software coupled with requirements documentation, validation planning document templates, and ready-to-execute validation test scripts for COTS-based functionality to streamline and optimize the validation process saving both time and money. The Enterprise Validation Management software is designed to automate many of the time-consuming, manual and paper-based processes delivering a more agile validation process commensurate with today’s fast changing cloud-technology. Since validation is a process which must be repeated each time software changes, the annual subscription of the Validation Accelerator ensures that your test scripts are kept up-to-date with each major release.

AI for problem soving processes

Implementing Artificial Intelligence for Problem Solving Processes

Problem solving is a universal process faced by all organizations when dealing with issues, complaints, incidents, deviations or non-conformances.

BPA’s development lab is currently exploring AI for predictive analysis applied to problem solving processes.

AI for problem soving processes

The developed machine learning algorithm compares similarities between new entered incidents and historical data, and suggests root causes, corrective actions for a quick and efficient solving.

The used algorithm was trained on the entire Wikipedia database for optimal similarity searching, not only looking for exact matches but also analogous matches that have the same meaning by using comparable terms, expressions and synonyms. For instance, when reporting a new incident “customer service was not good”, the algorithm will propose 3 root causes: lack of communication skills, lack of domain knowledge, lack of responsible behavior. In this case, the algorithm found a similarity with a previous incident “customer service delivered poor response”.

Behind the scenes, the process will compare new incidents with previous ones and calculate a correlation factor for each item. Suggested actions and root causes corresponding to the highest correlation factor will be proposed to the investigator.

The data model is updated each time new data is entered in the BPA software, improving the algorithm’s efficiency.

BPA’s AI features will radically help organizations solving problems faster and more efficiently, reducing costs and improving customers’ satisfaction.

BPA will progressively introduce AI to suggest risks and actions related to any quality improvement process, like audits, inspections, objectives, indicators, swot analysis, etc.

Conversational intelligence – read article and view video here – and AI features will soon be available with BPA Quality & Risk Management on Office 365.

BPA is proud to be on the front line implementing AI for regulatory compliance.

Applying AI to Regulatory Compliance – Introduction Video

Artificial Intelligence – AI – is a hot topic at the moment. Microsoft has developed technologies for predictive analysis, usually suited for large volume of data. Industry sectors like hospitals start using these technologies for predictive patient treatments. Another aspect of AI is conversational intelligence, also called bots. A bot is a virtual companion that will guide end users achieving their tasks.

BPA’s development lab is working on creating bots to simplify user experience with our regulatory solutions for Quality, Risk and GDPR. A first experimental bot was developed to guide end-users to submit an incident. Using a mobile device, the end-user is prompted to report an incident. The virtual companion asks for important information to be logged in the system, prompts for immediate actions to be done and optionally proposes to append photos to the incident.

Once the incident has been reported, a workflow starts and tasks will be distributed to the concerned users for qualifying and investigating the incident. At the investigation stage, AI is used for optimal root cause selection, based on 5 why and Ishikawa methodologies. AI will further be used for optimal CAPA/Risk management by retrieving relevant historical data in the system and guide concerned persons to solve incidents quicker and more efficiently.

The experimental bot for incident reporting was developed on Microsoft Teams and runs with any mobile device. It will be soon available for our Office 365 customers. BPA is very proud to be on the front line applying AI to regulatory compliance.

Cost Saving

Calculate Your Cost Savings with a Digital Solution

It’s not easy to deliver engaging, efficient experiences when you’re held back by pen-to-paper-based processes.

A digital solution offers a centralized location where organizations can efficiently store, organize, manage, access, and distribute information.

Cost Saving

For the quality/regulatory department, information typically includes forms (audits, incidents, non-conformances, CAPA, indicators, risks, equipment maintenance, training, etc.) and quality/regulatory documents. By giving collaborators quick and easy access to the information they need anytime and anywhere, digital systems help employees focus more time on their core activities.

What are cost saving opportunities with a digital regulatory compliance solution?

  • Electronic forms enforce collaborators to enter consistent information quickly and easily, reducing errors and manual rework.
  • Automated workflows accelerate the process of creating and distributing forms and documents across devices and platforms.
  • A digital system prevents collaborators to retype data at some point during the process thanks to data relations and automated reporting tools.
  • No paper processing is needed anymore, saving printing, scanning, postage and archiving costs.
  • Users spend a huge amount of time each day searching for information — an average of 37 minutes or 8% of the work day. Digital search tools can reduce search time by up to 50%.

Let’s crunch the numbers to see how much money your organization/department can save with BPA’s solutions.

Office 365 Quality and Risk Management

3 Reasons Why Office 365 Is the Ideal Platform for Quality and Risk Management

In our last article, we have mentioned security, audit and data loss prevention features that make Microsoft Office 365 the optimal platform for quality and compliance solutions.

Beside these features, there are major reasons why your organization should adopt Office 365 to improve the quality of your products and services.

Office 365 Quality and Risk Management

Lower Cost

A Forrester study demonstrated Office 365 delivers an ROI of 321 percent with a payback period of two months for the composite midsize organizations.

The study lists monetary benefits – more than $1M over 3 years – a midsize organization can expect:

  • Knowledge worker productivity gain
  • Savings from reduced IT support effort
  • Mobile worker incremental productivity gain
  • Savings from substituted Microsoft licenses
  • Savings from eliminated hardware, etc.

Office 365 Business Essentials starts at less than $5 per user/month which makes it accessible for any organization.

Better User Experience

From an end user perspective, Microsoft Office 365 provides an unequaled “one interface” experience grouping all important tools in a single page, like Office tools, reminders, emails, calendar and more.

Concretely, concerned users don’t need to login into different systems and switch interface to access documents, view important meetings, access emails or get alerts and reminders. This clearly improve user experience, productivity and reduce frustration to connect with different software.

Better Collaboration and Productivity

No other platform brings so many tools to improve collaboration and productivity. Teams and SharePoint bring great collaborative workspaces, including conferencing and discussions. Flow provides connectors to dozens of technologies and intelligent workflow features. Power BI brings the most powerful reporting tools. With Power Apps, end users can access data and documents with their mobile devices. Using forms, even external people outside from your company can interact with your organization.

BPA has developed the first and unique Quality and Risk management solution, natively built on Office 365, empowering collaboration, automating processes and improving quality.

Ask for a Free Trial Now

4 Features That Make Microsoft Office 365 the Optimal Platform to Run Quality and Risk Solutions

4 Features That Make Microsoft Office 365 the Optimal Platform to Run Quality and Risk Solutions

Quality is a pivotal part of every business, but Quality and Risk Managers know how difficult it can be to achieve or maintain. Quality and risk management solutions are available today to help manage these processes for you. However, they are virtually worthless if they don’t run on a secure and comprehensive platform.

4 Features That Make Microsoft Office 365 the Optimal Platform to Run Quality and Risk Solutions

Microsoft Office 365, a leading cloud-based service platform, offers robust, useful, and secure applications. One of these applications, SharePoint, enables companies to build efficient websites and services. Quality-focused technology providers today, such as BPA Solutions, offer quality and risk management solutions built on SharePoint, incorporating all the benefits that Office 365 has to offer.

Read about 4 Office 365 features that provide optimal security and risk mitigation tactics for quality and risk solutions below.

  1. Data Loss Prevention

Aside from your employees and customers, data is the most valuable asset of your business. Office 365 provides data loss prevention (DLP), which helps your organization protect sensitive information and prevent leaks. Office 365 DLP puts the power into your organization’s hands, giving it the control to identify, monitor, and automatically protect sensitive information across SharePoint and other applications.

  1. Information Management Policies

How you handle your content and information can vary based on industry, company size, or many other factors. Through SharePoint, information management policies enable organizations to control and monitor activities, such as content retention timeframes or which actions users are allowed to take with that content. Some of the predefined policies include retention, expiring out-of-date content, and auditing of document usage.

  1. Information Rights Management

Building on the last point, it is critical to set policies to make sure your business-critical information stays within your business’s walls. Office 365 Information Rights Management (IRM) helps prevent sensitive information from being printed, forwarded, saved, edited, or copied by unauthorized people.

  1. Auditing

Quality and Risk Managers know the destructive reality of having “too many cooks in the kitchen.” That’s why they need to have a clear log of who’s made what change and when. The Office 365 auditing feature tracks changes made by users to documents and other items on your SharePoint quality solution.

BPA Solutions has recently released a new edition of their BPA Quality solution, which is built on top of Office 365, infusing all of the features listed above into the solution and immediately integrating with other Microsoft technologies.

To learn more about BPA Quality on Office 365 and begin improving your quality and risk processes, contact a BPA quality expert or read more here.

The Customer is Key: Why a Digital QMS is Core to Business Success

Little is more important to your business than your customers. They are the heart of your business – what keeps your people employed and your products and services in production. This is why keeping your products and services in compliance with the top quality standards, such as ISO 9001, is so important – high quality leads to happier customers.

But keeping in compliance with these standards isn’t always easy, particularly if you aren’t currently using an automated QMS solution. Find out the 3 top ways an automated QMS solution can help you stay in compliance, and keep your customers happy below.

  1. Automation means faster resolution

Quality issues with your product or service are always a frustrating task to resolve, but they become even more frustrating if it’s hard to target where the issue stems from. This is where non-automated QMS processes fall short. If your Quality processes rely on your employee’s ability to, and patience with, sifting through mounds of paper or folders of Excel files, your ability to recognize quality issues or improve them is significantly stunted. Automating these processes, however, gives you the ability to more easily identify performance, find holes in processes, non-compliance with various mandates, and more – enabling you to attain faster resolution, and ultimately, keep up with customer expectations.

  1. Consistency keeps you competitive

Part of maintaining a high quality product is maintaining consistency. But maintaining consistent quality goes beyond the product itself. Your processes behind the scenes must also be consistent. This is where an automated QMS can help. An automated QMS can help you control your processes by enabling you with clear targets, clear metrics, and the ability to adjust accordingly. With more control, and ultimately, higher consistency with your processes, you’re bound to produce a consistent quality with your products, maintaining your ability to keep up with your competitors and maintain (even obtain new) customers.

  1. Obtain recognition as a leader in quality

One reason that many organizations seek ISO 9001 compliance is the corresponding recognition as an organization with high quality standards. Nothing screams “we care about our customers” more than proving to them that producing a high quality product is a goal of your organization – and automation helps you get there. With an automated QMS solution, your organization is equipped with the tools to more easily view gaps in quality, avoid potential operational risk, maintain consistency in the quality of your product and the quality of your processes, and finally – meet the ISO 9001 compliance.

If your customers are the true heart of your business, show them that producing a quality product or service for them is your top priority. Obtain ISO 9001 compliance by automating your Quality Management processes with an automated QMS solution.

BPA Quality is dedicated to helping your organization achieve success. Download our eBook or contact one of our quality specialists today to learn more.

Medical Device Quality Management Software for Small Businesses

Quality management software for medical device manufacturers is usually complex, expensive and out of reach for small and medium companies.

However this is no longer the case, BPA has just released an integrated quality and risk management software, affordable, flexible and adapted to small and mid-sized medical device companies. A new digital signature module has been developed to comply with 21 Part 11 CFR regulations (view video here).

Built on the CFR 21-compatible Microsoft Office 365 technology, BPA Quality and Risk Management is a cloud-enabled, secure, and scalable solution, delivering superior document management, workflow, collaboration and reporting tools in one single interface and providing an unequaled user experience.

No need for cumbersome and costly paper systems anymore, our digital QMS software facilitates communication between siloed departments, increases efficiency with automated processes and saves cost.

Office 365 + BPA Quality is the ideal QMS solution for small and mid-sized medical device companies.

Read more about BPA Quality