Quality Managers – We Will Change Your Life

Quality Managers – We Will Change Your Life

How looks a typical day in a Quality Manager’s life?

Beside operational quality matters, Quality Managers and their team spend a lot of time to administrate heavy paper systems.

Because of the lack of adequate systems, Quality Managers have to deal with a lot of Excel files, retyping data again and again to have consolidated information on processes. Excel is an individual solution that is not adapted to solve quality matters.

Database systems are common to store quality data, like non-conformances, CAPA and others. Even if databases have several advantages compared to Excel files, they miss user-friendliness and collaborative features. Usually, these databases have been developed internally and become obsolete once developers leave the company.

Plenty of digital Quality Management solutions exist in the market. They will bring several advantages like integrating many modules in one single solution. However most of these solutions are intended to larger organizations, they are expensive with a long time to deployment and often built on non-flexible proprietary technologies. Return on investment with such solutions is unclear.
unclear

Quality Managers, we know your pains and will change your life.

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Office 365 users, stay tuned it’s coming very soon for you too…

Quality Managers

Quality Managers – The Time Has Come to be Recognized for Your Work

Quality Management used to be an inessential responsibility plotted in the organization chart of many companies I was helping to get certified. It’s like there was no clear position in the organization chart for Quality Management. Even today, the Quality Management function is not always fully recognized.

Quality Manager

Like a music director leading his musicians, a Quality Manager needs to have very close relations with all service managers in the organization. The concert will only play in perfect harmony if director and musicians do their part of the job. There needs to be quality orchestration.

Unfortunately, in many organizations, Quality Managers have to play the music alone, with limited support from process managers and poor sponsorship from General Management. Chasing and motivating collaborators that are not fully engaged in the QMS becomes a daily task for Quality Managers.

As a result, Quality Management has turned out to be centralized, less efficient and Quality Managers lack recognition for their work.

The time has come for Quality Managers to be recognized for their work.

>> Discover our SharePoint QMS solution

Office 365 users, stay tuned it’s coming soon for you too…

quality consultant proposal

Unique Value Proposal for Quality, Compliance & Risk Consultants

If you have extensive consulting experience and network contacts within the Quality Management sector, and if you have access to decision makers and influencers, then this proposal is for you.

Performing sales organizations don’t work with spreadsheets anymore, but with powerful CRM systems. In the quality management domain, companies that run a digital QMS system will drastically increase their competitiveness and efficiency.

Today, customers expect advice from their consultants in order to select the most adapted digital solutions for their needs.
Unique Value Proposal for Quality, Compliance & Risk Consultants

 

Consultants, BPA is aware of this and has developed the most flexible digital QMS system to support your consulting methods, tools, and strategies. You and your clients don’t have to adapt to a rigid system anymore— BPA will adapt to you. As a consultant, you have full control in configuring the QMS for your clients, sharing content and methodologies, proposing added-value services, and getting additional recurring revenues. Our QMS system is accessible anytime and anywhere for you and your clients, even very small companies with less than 20 users.

Here is our promise to your customers. We want to make Quality, Compliance, Risk Managers recognized in their organizations by delivering a collaborative and participative QMS tool, where collaborators will be engaged. We want to reduce Quality Managers’ administration work with a simple and integrated Microsoft-based system. Finally, we want to facilitate the certification process and help your customers develop their businesses.

Consultants, here is our proposal for you. Through your network, you have customers that seek to implement digital Quality Management Systems. We want to make it worth your time if you bring us a lead, a qualified lead or a deal, and propose you high commissions from 5 to 30% in case the deal is closed.

We believe that this is a great proposal that can really create a win situation for all involved.

>> Make Your Clients Happy in Becoming a BPA Partner

quality manager

Breaking News – A New Era Has Come for Quality Managers…

Many factors explain Quality Managers’ life has become harder today.
Quality Management

We live in a more and more regulated world, which means Quality Managers are not only responsible for Quality Management anymore but also health, security & environment management.

More and more regulations and quality standards have been created the last decades and Quality Managers are now frequently audited on many standards to maintain certifications.

Not later than 2018, companies need to transition to the latest ISO 9001:2015 release and this will require additional efforts for Quality Managers to manage risks, opportunities and more.

As a result, quality management systems become more and more complex and heavy to manage. Quality managers spend a lot of time to manually administrate their QMS because no adequate digital solution exist.

But, a new era has come for Quality Managers. Discover our SharePoint QMS Now

Office 365 users, stay tuned, it’s soon available too…

ISO 9001-2015-QMS

2018 Deadline: How a Digital QMS Can Help You to Renew Your ISO Certificate

2018 is the deadline when ISO 9001 certified organizations will need to move to the new ISO 9001:2015 standard.

Meeting the new ISO 9001:2015 requirements will need additional extensive paperwork and Excel spreadsheets. Do you really want to make your actual QMS even more complex to manage?

Why is now the right moment for your organization to move to a digital QMS?

An ISO 9001:2015 compliant digital QMS will ease the transition to the new standard because tools have been specifically developed with quality professionals to match new requirements, such as risk management, opportunity management or SWOT analysis.

digital QMS

An integrated digital QMS will drastically save time for Quality.  Rather than spending time to administrate heavy paper-based systems and tons of Excel spreadsheets, Quality Managers can focus on value added processes and transition to the new standard. With an integrated QMS, you get the full picture for any quality process and drive continuous improvement.

ISO 9001:2015 brings a new opportunity for your organization to rethink your QMS and make it more efficient.

In moving from a paper-based and standalone system to a digital collaborative QMS you will better interact with collaborators and executives and make your QMS participative. Engaging with collaborators will bring your QMS to the next level.

The 2018 deadline is approaching. Use this great opportunity for your organization to simplify and improve your existing quality management system by moving to a digital integrated and collaborative QMS.

BPA has developed a cost-effective and integrated collaborative QMS based on the latest Microsoft SharePoint and Office 365 technologies.

Save time and cost while making your QMS more efficient and compliant with the new ISO 9001 standard.

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SharePoint QMS

Why SharePoint Is the Right Foundation for Your QMS

SharePoint 2016 is the sixth generation of the worldwide number 1 collaborative technology developed by Microsoft. With millions of users and more than a billion of revenues, the Microsoft SharePoint technology has reached maturity. The SharePoint ecosystem includes thousands of developers, partners and third party tools.
 
SharePoint has become a central piece in Microsoft’s Office 365 cloud offering. Many new technologies have been lately developed by Microsoft that will accelerate digital transformation, like Microsoft PowerApps and Flow allowing users to access data anytime and anywhere. A new era of collaboration has started and the technology is ready for it.
 

Sharepoint

 
Microsoft SharePoint is a feature-rich platform, including native and powerful document management, workflow automation, social and chat (Yammer), telephony (Skype), email, mobility, search any many more features. Thanks to the native integration with Microsoft Office tools, SharePoint gives the best user experience.
 
The SharePoint technology allows workspaces on demand creation, and provisioning a new site takes less than a minute. A company can create independent workspaces per business unit, plant or region. The technology is fully scalable and adapted for small to large organizations.
 
SharePoint’s entry cost is very low. It can be deployed on premises or used in the Office 365 cloud. SharePoint Foundation doesn’t require any additional software license if you have a Windows server running.
 
SharePoint brings a powerful foundation for your QMS initiatives. However, Microsoft SharePoint is not a QMS software.
 
BPA has developed an all-in-one and ready-for-use QMS solution built on Microsoft SharePoint and Office 365 technologies. 30+ components have been developed to drastically improve user experience, user interface and user productivity when using SharePoint.
 
ready-for-use QMS solution built on Microsoft SharePoint and Office 365 technologies

 
Using BPA on the top of SharePoint will avoid any costly and time-consuming SharePoint development, and our components solve challenges met by developers again and again.
 
BPA aligns with IT strategies to reduce the number of technologies deployed and cost. Compared to risky proprietary technologies, BPA is built on a no-risk and standard technology. This considerably lowers the risk of software obsolescence.
 
Maximize your return of investment with our cost-effective QMS solution.
 
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Introducing BPA Quality 2017

Introducing BPA Quality 2017

BPA Quality 2017 is the next generation of software for quality, risk, compliance management and internal control built on the #1 Microsoft SharePoint technology.
Don’t spend time retyping data in heterogeneous Excel files and systems. With BPA you can replace Excel/Office files & databases with one single integrated solution, drastically saving administration cost.

BPA is a unique solution supporting all needed collaborative technologies for improving your processes, like task, email, calendar, picture and document management. As a result, you get the full picture for any quality record.

For example, you can add an Outlook email as a non-conformance including attachments. Pictures can be added to describe the problem. Emails and documents will be managed and traced in the system. Tasks and meetings will be tracked in the tool and synchronized with Outlook.
Introducing BPA Quality 2017

Let your BPA QMS distribute tasks automatically and plan the work for each concerned end user.
Automatic tasks with email notifications are sent to the concerned persons to qualify, investigate, define an action plan and verify effectiveness of related actions. This will drastically save time and cost.

BPA Quality 2017 includes prebuilt Nintex workflows for non-conformance and compliance document approval processes. In 2014, Forrester Research conducted a study “The Total Economic Impact™ of the Nintex Workflow Platform” and interviewed many organizations. Benefits of automating processes with SharePoint were clearly demonstrated. 3-year results are the following:

  • ROI : 176%
  • Payback: 10,5 month
  • Productivity increase per user: 8-15%

BPA Quality 2017 will save you time and money while improving efficiency for every compliance processes.

>> Access Your BPA Quality 2017 Trial Now

Typical problem solving process

Moving Beyond Excel Spreadsheets – What are The Real Benefits of a Digital Collaborative QMS?

In this article we will highlight benefits of digital collaborative QMS for a typical problem solving process.

How does a typical problem solving process look like for most organizations?

Considering the 8D methodology we have following steps for a typical problem solving process:

Typical problem solving process

What are typical risks for this process?

An Excel spreadsheet is certainly not a good way to register problems because one person at the time can modify the file. A form solution allows internal or external stakeholders to register a problem. This avoids the quality manager to register problems for everyone in the organization and make the system participative.

How can you link emails, documents, corrective actions, risks and activities with the problem? Spreadsheets and typical database systems are not adequate to handle related data and documents with a problem. Typical spreadsheets and database systems are disconnected and you will miss the overall picture. The ideal system should display a 360 degree view of a problem with all related information coming from different sources, like emails, tasks, calendar, documents or others.

How to make sure the right persons are alerted during the problem solving process? With a traditional paper or database system, each end user has to manually alert the right persons throughout the process. Obviously it is a risky process, it’s also time consuming and usually not efficient. With a digital collaborative system, workflows and automatic alerts will make sure the right people are alerted. Workflows enforce that corrective actions are efficient prior closing any QMS process. Also, workflows will shorten any process’ lifecycle.

What about reporting? With a paper system, reporting is a time-consuming manual work. With a digital system, you can view instant reports or export any data into a spreadsheet for advanced reporting. No manual work is needed anymore.

What are the benefits of a digital collaborative QMS?

Benefits are numerous:

  • Reducing overall cost, like IT cost by replacing multiple heterogeneous systems by one integrated solution, reducing administration and labor cost by replacing a paper-based system with a digital solution, reducing cost of poor quality by having an integrated and collaborative PDCA system that will impact enterprise strategies and objectives.
  • Automating processes with automatic tasks and alerts. Workflows will drastically reduce lifecycle for each process and maximize productivity and efficiency.
  • Moving stakeholders back in the center of your QMS. Having a participative QMS system will help to spread the word about quality in your organization.
  • Meeting regulations will lower risks, legal fees and exposure for your company.

In this article we have discussed the numerous benefits of a digital collaborative QMS compared to typical paper or database systems. Benefits will be the same for any process, like the problem solving process in this example.

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Document approval workflow

CFR 21 Part 11 Compliance & Electronic Signature

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States FDA regulations on electronic records and electronic signatures. Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

In this article we present a simple use case to configure a system for 21 CFR Part 11 compliance.

To handle the “signing signature” referred to in Part 11 documentation, a couple departures from BPA Quality and SharePoint are needed. The first is an e-signature custom field to capture the username and password and the second is a workflow that handles the document approval from start to finish.

Microsoft and SharePoint technologies propose many tools for regulatory compliance, like active directory services, SQL Server database and BI services, SharePoint list and library permission settings, version and audit settings.

In this typical use case, document managers (editors, approvers, distributors) have contributor rights for the document library. Approved documents will be published in another library or site (e.g. company intranet) where end users have reader rights.

Document approval workflow

Example of a graphical document approval workflow.

The e-signature add-on can be added as a custom field in SP. The field stores, in an encrypted form, the user identity, time and date of signing. This ensures only authorized persons can modify a document, document properties or any quality record. E-signature is required each time documents, document properties or quality records are modified. With no valid signature, a red stamp will be visible in the document or record properties.

Document properties

The e-signature custom field in the document properties makes sure the document was approved by the right people prior publishing.

With BPA Quality, end users can easily access published documents from an organizational chart or a process map.

Process map

The process map is the ideal entry page for end users to access published documents for the different processes.

Risk assessment

Risk Based Thinking

Risk based thinking is a big change in the new ISO 9001:2015 standard. Risk management is a proactive way to take action prior unfortunate events happen.

Where should you start? How can you detect risks and hazards in your organization?

After having determined the context of the organization, like stakeholder expectations, competitive analysis… you have to describe key processes in your organization with their input, output, activities and indicators. Risk factors can be identified with a SWOT analysis for any process. In the daily business, risk factors will be identified from any P-D-C-A improvement process, like objectives, KPIs, nonconformities, audits, management reviews, etc.

50+ described processes

BPA comes with 50+ described processes to help you to identify risk factors.

How to handle risks?

The Deming improvement wheel applies for risk management. Risks need to be identified, periodically assessed, treated and monitored.

How to assess risks? What is the cost of risks?

Risks can’t be measured but will be periodically assessed by your responsible team, based on impact (if the risk occurs) and probability (of occurrence). Additional factors can be added like a detection factor (used with FMEA). The risk severity is a multiplication of these factors. Based on the risk severity, controls and treatment actions will be done. The cost of a risk can be calculated based on severity multiplied by cost factors (e.g. number of non-production hours * cost of a non-production hour).

Risk assessment

The risk scorecard allows displaying risk assessment values and trends for each risk and period.

How to control risks?

Controls can be physical assets (e.g. sprinklers, detectors) or procedures (e.g. procedure in case of fire) to reduce the impact or probability of a risk. Controls need to be periodically verified.

Considered controls

Frequency and compliance of each control can be monitored easily with the BPA linear calendar.

How to treat risks?

Based on the risk severity or cost, treatment (corrective, preventive) actions will be declared and tracked. Effectiveness of actions will be verified. A prebuilt workflow makes sure actions are followed-up until resolution.

How to monitor risks?

A risk scorecard is ideal to monitor the risk severity and trends for the different periods (e.g. monthly or quarterly). A heat chart can be used to display the risk severity for specific risks.

Risk

The BPA heat chart displays risk severity and trends for selected risks.

Why Excel is not enough? What tools can you use?

Microsoft Excel is not a relational tool. You won’t be able to optimally track actions, tasks, emails or documents related to risks with a spreadsheet. More important, Excel is not a collaborative tool and you won’t be able to automate the risk treatment process, distribute tasks automatically or collaborate with you team to assess, treat or monitor risks.

BPA’s integrated QMS and risk management software is the ideal tool to identify, assess, treat and monitor risks. BPA is built on the #1 Microsoft SharePoint technology and brings a simple and powerful framework to help you to deploy a collaborative risk based thinking tool.

Risk details

A collaborative risk management tool like BPA allows tracking treatment actions, tasks, emails and documents related with any risk. Automatic reminders and alerts will be sent to the concerned persons.

BPA’s risk based thinking software applies for any standard like ISO 9001:2015, ISO 31000, HACCP, FMEA or any other risk methodology.

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