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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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.

Context of the Organization

This section of ISO 9001:2015 is for your organization to have a clear scope of the environment it engages in and direct + indirect customers that it serves.

BPA provides a SWOT analysis tool to assess the influencers that come from both external sources (Opportunities and Threats) and internal sources (Strengths and Weaknesses).

SWOT


The competitive intelligence tool gives a macro view of the markets, technologies, competitors, products and patents your industry is facing in the current state.

Competitive Intelligence

Once you set the boundaries of the organization, your team can get to work on identifying all of the groups that your business will touch, like customers, owners, collaborators, regulators, bankers, etc.

Stakeholders

Using our SharePoint QMS, native survey tools can be used to help understanding the needs and expectations of interested parties.

Change Management

Planning of changes refers to those changes that are part of everyday business, new programs, changing financial structures, end-of-life of a product and obsolescence of an equipment. All of these changes can affect the QMS.

With BPA, each change request is considered as a project with timing, cost and impacts on the QMS.

Impacted QMS documents can be selected and related document responsible persons will be automatically warned by the system.

Change Request

Like typical problem solving processes (six sigma, nonconformity and CAPA), 8D or DMAIC project methodologies can be used to follow-up with change requests.

The consequences of the changes have to be understood. Risks and action plans will be defined and monitored in the system to minimize impacts.

BPA makes sure you follow PDCA for any change. KPIs, like project savings, will be periodically monitored.

Process Approach

ISO 9001:2015 utilizes a process approach in the implementation and auditing of a QMS. A process has five distinct characteristics:

  • Inputs
  • Outputs
  • Use Transformation
  • Measurability
  • Ownership

In this last revision, the process approach was enhanced with the consideration of the PDCA cycle and risk-based thinking.

Therefore, having a process approach helps with multiple standards, like environmental, safety and quality standards.

Process

A process map is the ideal entry page for end users to drill down the QMS.Strategic Planning

50+ processes are described based on ISO 9001:2015 characteristics, including process purpose, inputs, outputs, indicators, customers and linked parent and child processes.

Sub Process Detail

For each process, end users can view the process-related compliance documents, risks, key performance indicators and knowledge articles.

In this example, the end-user can click to open the nonconformity process flowchart.NC Process

Data and information is automatically consolidated at the process level allowing process owners efficiently monitoring and improving processes.

Deploying Your ISO 9001:2015 Quality Management Software

BPA Solutions has developed a flexible and cost effective quality management software to help you to deploy ISO 9001:2015 in your organization.

Process Approach

  • Achieve continuous improvement with a collaborative PDCA tool
  • Navigate your QMS easily from a graphical core process map
  • Select your key processes among 50+ described processes
  • Be compliant with any QHSE Standard
Process Map

Drill down the process map to view the process summary page and related documents, KPIs and risks. (BPA Quality screenshot)

Integrated Internal Audit Tool

  • 100+ predefined ISO 9001:2015 & supplier audit questions
  • Easily plan and schedule internal audits
  • Manage auditor skills and audit plans
  • Track audit findings, risks and KPIs
Audit Questions

Select among 100+ predefined ISO 9001:2015 audit questions to prepare your audit. Generate an audit
checklist in a mouse click. Append risks, findings… related to your audit. (BPA Quality screenshot)

Context of the Organization

  • Tools for competitive intelligence, stakeholder expectations, supplier evaluation
  • Make SWOT analysis and track business improvement opportunities
  • Track satisfaction for each customer interaction
  • Manage customer surveys

 

Strengths

The SWOT analysis tool will help you to declare and track QHSE improvement opportunities

Leadership & Customer Focus

  • 50+ described processes to determine your needed skills
  • Develop skills through continuous collaborator training
  • Develop and maintain knowledge with a wiki tool
  • Track important customer interactions
Organization Chart

Drill down the organization chart to view responsibilities with their related collaborators. Plan training, develop skills and knowledge. (BPA Quality screenshot)

Planning & Risk-Based Thinking

  • Identify risks from any QMS process
  • Periodically assess considered risks using scorecards
  • Mitigate risks with controls and actions
  • Monitor risks with heat maps, reports and KPIs
options

Periodically assess identified risks with a scorecard. Plan periodic controls and actions to mitigate risks. (BPA Quality screenshot)

 

Support & Compliance Documents

  • Microsoft SharePoint brings the most powerful document management features
  • Prebuilt Compliance Document Management workflow
  • Design your own no-code workflows for any process
  • Manage equipment, assets and resources
Compliance Documents

Start from a document template and update metadata directly in your Office application. Be sure your document gets approved prior to publishing. (BPA Quality screenshot)

Operation & Problem Solving

  • Manage product development projects
  • Manage product and process FMEA
  • 8D CAPA problem solving tool
  • Track and evaluate suppliers
Workflow Progress: NCR Process

Prebuilt 8D CAPA problem solving workflow. Workflows will drastically reduce any process lifecycle and automatically alert the right person at the right time. (BPA Quality screenshot)

Performance Evaluation & Improvement

  • Manage PDCA processes and achieve continuous improvement
  • Track compliance for each process in a single dashboard
  • Track management reviews and actions
  • Manage objectives and KPIs
Considered KPI

The overall dashboard shows compliance for each process in a snapshot view. (BPA Quality screenshot)

The Best QMS Software

  •  BPA is an all-in-one QHSE solution which covers all ISO 9001:2015 requirements
  •  BPA gives the highest flexibility to customize your solution to your needs
  •  BPA is based on #1 Microsoft SharePoint technology
  •  BPA gives the highest user experience
  •  BPA gives the best price/value

Drastically Save Costs with BPA

  •  Lower the total cost of ownership of your project
  •  Lower IT cost in replacing heterogeneous systems
  •  Lower admin/process cost through process automation
  •  Lower the cost of quality with our integrated PDCA tool

Are you tired dealing with tons of Excel files, heterogeneous systems, time-consuming reports and paper-based processes?

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Select The Best Quality Management Software For Your Company

What are important criteria to select the best quality management software for your company?

 
Quality managers are used to work with tons of Excel files, heterogeneous systems, time-consuming reports and a lot of paper-based documents.

 
best quality management software

 
Our comparison table will help you to select the best quality management software for your dedicated needs, based on criteria like:

  • Flexibility and adaptability
  • Covered features
  • User experience
  • Technology
  • Cost

View our quality management software comparison table