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…

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.

Ask for a free trial now!

 

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.
 
Ask for a free trial now!

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.

Ask for a Free Trial Now

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.

Access your BPA Quality Trial

Root Cause Analysis

The root cause analysis is a crucial step in typical problem solving processes.

BPA helps you to deploy a workflow-driven collaborative problem solving process based on 8D, DMAIC or any other methodology.

For a typical problem solving process, like nonconformity handling, the main workflow steps are nonconformity data qualification, root cause investigation, action plan definition and action effectiveness measurement. Contributors are automatically warned during the problem solving process.

Workflow Progress NCR Process

 

Possible root causes can be investigated based on the 5 Whys methodology.

Non-Conformances Root Causes - Oil tanker

 

Based on the 5 Whys analysis, root causes can be identified using Ishikawa fishbone factors, like Management, Man, Method, Measurement, Machine and Material (6M).

Root Causes

 

The dashboard displays statistics about root causes and overall process indicators in real time.

Dashboard

Organizational Roles, Responsibilities, Collaborator Skills & Training, Knowledge Management

The leadership section of ISO 9001:2015 describes that roles and responsibilities must be assigned, communicated and understood.

The organization chart makes it easy for end users to understand the organization functions with their responsibilities.

Organization Chart

By drilling down the organization chart, end users can view the related sub processes a process owner is responsible for and the assigned collaborators for this responsibility.

Process Owner


Collaborator competencies and training are tracked in the software. This ensures skills are developed and maintained within your organization.

Collaborator

Using wiki libraries, selected contributors can write knowledge articles, best practices and lessons learned, including multimedia content.

Deming

Six Sigma Project Management

Six sigma has its roots in statistical process control. When a process operates at the six sigma level, the resulting products and services are 99.9997% defect free.

Critical-to-quality metric


As an example for drug prescriptions, improving the process capability from 3.8 sigma (99% good) to six sigma (99.9997% good) would reduce wrong drug prescriptions from 200,000/year to 68/year.

The six sigma program has 3 key elements:

  1. Create standardized, disciplined problem solving approach used across company
  2. Drives measurement and data-driven analysis of metrics that are crucial to customers
  3. Focuses on reduction in variation of key metrics

BPA allows tracking your six sigma projects based on the DMAIC methodology (Define, Measure, Analyze, Improve, Control). The visual project tracking tool gives an overview of your six sigma projects with their current DMAIC stage.

Project Tracking

The project detail page gives a 360 degree view about your six sigma process improvement project, like the project team (black belt, green belts, etc.), selected root causes, corrective/improvement actions, controls, tasks and documents (control charts, etc.).

Six Sigma Overview

Like any PDCA process, key six sigma project indicators are periodically monitored, using scorecards.