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.