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.

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3 Reasons to Move Away from Paper-Based Quality and Risk Processes

If you’re part of the Quality and Risk Management team at your organization, you know that the job isn’t easy. Avoiding or mitigating risk to maintain the highest quality for your company’s product or services oftentimes entails numerous disparate and even tedious processes. Further complicating things – many organizations today still rely on paper-based processes: hundreds of disconnected, hefty Excel files, a seemingly endless number of filed-away compliance documents, and more.

Luckily, in today’s technology era, there are integrated digital solutions that exist to simplify the jobs of Quality and Risk Managers. The problem? Not everyone is embracing digital transformation. If you’re still finding yourself buried in Excel files or stacks of paper documents, here are 3 reasons you should embrace a digital QMS solution.

  1. Efficiency is key to any organization

Regardless of what industry you’re in – you and your colleagues don’t have time to waste sifting through stacks of paper documents or clicking through Excel files. It’s a massive waste of time, energy, and ultimately – company dollars. In fact, companies today can lose up to 20-30% of revenue due to inefficient processes. Stop sifting through piles of paper and move to an automated system to increase efficiency and reduce unnecessary company spend.

  1. Reliance on paper increases risk

If you are focused on quality and/or risk management, your job is to reduce potential risk in your business – not add to it! So why rely on cumbersome processes that could potentially increase room for error? What happens if that Excel file containing patient or customer information gets unintentionally deleted, or that intake form lands in the trash rather than a file cabinet? The truth of the matter is that relying on paper-based processes pokes holes in your ability to maintain quality in your organization – widening your room for error and opening your business up to risk.

  1. Digital QMS solutions put the power in your hands

What if you could manage all your company’s important documents in one integrated system, in a format that enables you to easily identify compliance issues, areas for quality improvement, and KPIs? That’s what going digital with your Quality and Risk processes allows you to do. Having this information easily accessible and identifiable to those in management puts the power back into your hands. Rather than feeling lost, confused, or frustrated, your QMS can enable you to feel empowered and in control of your business.

Move away from archaic paper-based quality and risk management processes and adopt a digital solution to reduce cost, increase efficiency, and empower your organization – fulfilling the highest quality your organization can and the necessary compliance mandates. To learn more about the benefits of moving to a digital QMS solution can empower your organization, contact one of our quality experts at BPA solutions or read more here.

BPA Quality Was Nominated by the European SharePoint Community

The European SharePoint and Office 365 Conference just terminated two weeks ago in Dublin, Ireland. 2,000 developers, IT professionals and Business Decision Makers have attended to learn from the world’s best SharePoint, Office 365 & Azure speakers.

We are very excited to have been nominated twice with BPA Quality, by the conference organizer, as finalist for the most innovative SharePoint solution and best Office 365 add-in.

This year the awards went to LiveTiles and KanBo! Congratulations, well-deserved!

“I’m very happy of this nomination because the competition is big. Congratulations to the whole BPA development team which has worked really hard to release our 365 apps. We have succeeded our challenge to have one single solution running on SharePoint 2013, 2016 and Office 365, with almost the same code.”
Dr. Boris Lutz, Founder & CEO at BPA Solutions

BPA Quality can now be installed in your Office 365 tenant. All native features from Office 365 are available, like instant discussions, collaboration, Office applications, workflow automation, mobile solutions, powerful reporting and more. The solution includes 30+ BPA modular functions to customize the solution to your needs, with no code. Power users are autonomous to extend the solution.

“It’s a fantastic opportunity for quality teams all over the world to have a ready-for-use digital quality and risk solution available in the Microsoft 365 cloud, including tools like PowerApps, Flows, Power BI, Forms, Teams and more.”
Belinda Schöni, Co-Founder & CEO at BPA Solutions USA LLC

Automation is the key to running an effective quality program. Become accustomed to lower risk profiles and simpler engagement on quality approaches. With BPA Quality and Risk Management, you can take a templatized approach to the most common quality and risk management functions and internal controls—keeping your focus where it belongs: on your business.

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Benefits of Digital Quality for Your Organization

Digital Quality Gives Executives a Cockpit to Pilot Their Enterprises

A QMS will not only guarantee the quality of your products but also the quality of all related processes to finance, design, manufacture, market, sell your products & services and get profits. In addition, the goal of a QMS is to obtain satisfaction of all internal and external stakeholders.

QMS

Because a QMS englobes all processes, it’s a very powerful management tool to pilot the organization. The QMS dashboard provides all important KPIs, risks and improvement opportunities to make sure key processes are efficient.

BPA Quality is an integrated QMS software providing the most powerful reporting tools for executives to pilot their organizations.

A Digital QMS Helps to Solve Pain Points in the Daily Business

Every business, regardless of size or industry, is concerned with the quality of its product and its overall risk profile. Now there’s a unified, simplified, automated, and easy-to-use solution to address those concerns head-on: BPA Quality & Risk Management.

For Quality, Risk & Compliance Managers, CFO and Process Managers, regardless of industry and company size, BPA helps to solve pain points like:

  • Manual processes
  • Outdated technologies
  • Disparate, cumbersome, and costly paper systems
  • Costly developments of data-entry ready solutions on top of SharePoint/O365

Digital Transformation Has Reached Quality Processes

Digital transformation has not equally reached all company services. HR and CRM processes are digitalized since years. In the contrary, QM processes are usually Excel and paper-based.

Digital quality will help Quality Managers to:

  • Save costs
  • Improve quality
  • Take faster decisions
  • Reach 365 daily quality
  • Develop a preventive attitude
  • Engage and motivate collaborators
  • Spend time on interesting activities

BPA is the First QMS Software Available on Microsoft Office 365

BPA Quality is the first and only all-in-one QMS solution running on Microsoft Office 365, interfacing with tools like instant discussions, team collaboration, workflow automation, mobile solutions, reporting and more. BPA Quality is the most advanced QMS solution in the market.

BPA quality

BPA Quality for Office 365 – Overview Video

BPA Quality is an all-in-one and interrelated Quality and Risk solution, built on Microsoft Office 365.

BPA is built to address the most common compliance standards including ISO9001: 2015, CFR 21 part 11 and others, regardless of industry and company size.

BPA helps you to engage with all collaborators, in order to make your QMS participative and to facilitate continuous improvement.

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Quality System CFR 21 Part 11 Compliant

How to Make Your Quality System CFR 21 Part 11 Compliant

In this article we will discuss major CFR 21 part 11 requirements. We will present how an Office/SharePoint-based quality management system complies with relevant regulations for the life science industry.

People who use systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and the confidentiality of electronic records.

 

Quality System CFR 21

This means an electronic system needs to clearly identify users and assign the right permissions to create, validate or read documents inside and outside the organization. Electronic signature makes sure authorized users can prepare and edit documents. Once a document is published, the system declares it as a record for the specified retention period. Information right management policies restrict users from copying or printing documents, even if documents are saved outside the system. Workflows enforce document approval and signoff. An audit trail has to be kept with a document throughout the document and record life cycle. Most of these technologies are part of native Microsoft Windows, Office and SharePoint.

Signed electronic records  clearly indicate the following information: the printed name of the signer, the date and time when the signature was executed, the meaning or responsibility associated with the signature. With Microsoft Office and SharePoint, digital signatures are stored as part of the document. Electronic signatures are stored as part of the audit trail and metadata associated with the document when signed as part of a workflow. The linkage between signature and document is maintained by the server.

Each electronic signature shall be unique to one individual. With Microsoft Office and SharePoint, Active Directory enforces a unique user ID and password for each user. Procedures and policies should be in place to ensure user credentials are periodically checked. Failed login attempts will be logged by Windows Server and related user accounts can be locked out.

Three topics need to be addressed when validating the system: installation qualification, operation qualification and  performance qualification. In the end, the system should perform to the end user’ needs.

The implementation of an electronic signature system must be simple for end users but rigorous enough to meet the organization’s need for record keeping within the organization.

BPA Quality is running on the latest Microsoft SharePoint and Office 365 technologies. BPA contains all necessary technologies to build a CFR 21 Part 11 compliant system. BPA Quality is cost effective and adapted to the needs of very small to large businesses.

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Proces map

Driving Efficient Risk Management

Risk management is a fundamental part of your Quality Management System. In the latest ISO 9001:2015 quality standard, risk management has become a central preoccupation.

Risk management is about developing a preventive attitude to avoid the occurrence of unfortunate events. In managing risks, companies can save resources, improve productivity and increase collaborators’ safety and health.

Not just used in banking or insurance organizations, an efficient risk management can have a direct impact on profits, revenue and business continuity.

A typical risk management process contains 4 main steps:

  • Risk identification
  • Risk assessment
  • Risk treatment
  • Risk monitoring

It’s good to start by defining company processes prior to identifying risks. A process map illustrates value added and resource processes in order to deliver valuable products/services to satisfy customers.

 

Knowing issues, indicators and risks for each process gives clear insights on how to make improvements.

There are 2 ways to identify risks, on the strategic or operational level. SWOT or stakeholder expectation analysis are great tools to identify strategic risks. In daily operations, issues, complaints, audits, correctives actions, indicators, etc. are typical events used to  detect risks. A recurring issue is a typical source for declaring a new risk.

 

 

Different methodologies exist to assess risks. A simple one is to assess probability/occurrence and impact/gravity of risks. The risk severity is the multiplication of probability by impact factors. The impact is sometimes expressed as a monetary value. In FMEA’s methodology (Failure Mode and Effects Analysis), the risk severity is the multiplication of three factors: impact, probability and detection. The risk severity is often displayed in a risk heat map for a specific period. A scorecard is an ideal tool to monitor risk assessment values over  time with their trends.

methodologies assess risks

 

High severity risks display in the red zone of the heat map. These risks need to be treated. Corrective actions are assigned to the process owners, to reduce the risk probability or impact. Periodical controls are set to monitor risks.

Risk compliance documents will be needed to describe your risk methodologies and procedures with their related instructions. These documents are usually part of your quality document management system.

Excel spreadsheets are not ideal to manage risks with their related actions and controls. Excel is a personal tool that is not adapted for collaborative work.

An integrated digital quality management software like BPA Quality will help quality managers to have a participative quality and risk management system.

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BPA Quality for Office 365 – A Game Changer For Quality Managers

It’s almost released. BPA Quality for Office 365 represents a game changer for Quality Managers. It’s a plug and play QMS software fully integrated with your Office 365 system.

The time of spreadsheets, databases and expensive QMS solutions is over. Quality Managers, we will change your life.

The 4th generation of BPA Quality integrates with the best Office 365 collaborative technologies. Embedded technologies in BPA Quality allow instant discussions, team collaboration, workflow automation, mobility, advanced reporting and many more.

QMS Office

The time for digital quality has arrived. The latest Microsoft technologies will help making your QMS participative, distributing tasks to the concerned persons and taking faster decisions.
Decentralizing the QMS, Quality Managers will have more time to spend on interesting activities to renew certificates and improve processes.

BPA’s digital quality software will prevent administration work to manage heavy paper systems and drastically save costs.

Typical QMS software are complex, expensive and not flexible. The time has come for a user-friendly and cost effective solution adapted for any industry sector and company size.

BPA Quality for Office 365 is soon available to be installed from the Microsoft store.

>> Let us know if you’re interested to know more about BPA Quality for Office 365.