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?

Contact us for a FREE TRIAL NOW

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

US Trade Adjustment Assistance Program to Get Funds For Your QMS/CRM Project – Do you qualify?

Article by Boris Lutz, CEO of BPA Solutions, March 2016

 

BPA Solutions would like to call your attention to a relatively unknown US federal program that can provide funding for US based organizations from all industry sectors, who have experienced a recent decline of minimum 5% in sales and employment as a result of import price competition.

Your firm may qualify to get funds.

Trade Adjustment Assistance for Firms (TAA), a federal program, provides financial assistance to firms in all industries affected by import competition. Sponsored by the U.S. Department of Commerce, this federal assistance program pays half of the cost of an ISO implementation project or any other project to improve global competitiveness.

“The TAA Program is a great way for any firm to get funds to strengthen their position in the market. It is very easy to get started and I encourage each firm that needs to develop additional capabilities – like implementing an ISO 9001 or CRM project – to find out whether they qualify for this great program.” says Dr. Boris Lutz, CEO at BPA Solutions.

Grants for an ISO 9001 Quality Management System implementation are available at a 50/50 cost sharing basis, up to $75,000. Over the last decade, many US based companies have been awarded with a matching grant to help them to develop their businesses just from applying for the Trade Adjustment Assistance Grant Program – so can you.

The program is called Trade Adjustment Assistance (TAA). There is no cost to find out if you are eligible for this program. Through the TAA program, your firm might receive up to $75,000 in government assistance to develop and implement strategies including the required resources to implement an ISO-based Quality Management Systems (ISO 9001, ISO 14001 EHS, OHSAS 18001, etc.), or CRM system to improve your competitive edge. Typical projects are: quality management system implementation, sales and marketing improvement, new product development, productivity improvement, computer system upgrades, and export feasibility studies.

Let see how this program can help you to improve your competitive position and profitability.

Initial Application

Basically, any firm headquartered in the U.S. that can show a 5% decline in sales (dollar volume) for a current period (most recent 12 months) versus the same period last year, or a 5% decline in employment for the same period, and is indeed import-impacted, is eligible to be approved by the Department of Commerce (DOC). This U.S. government grant program can provide up to $75,000 of U.S. government funds on a cost sharing basis for firms that have been hurt by import competition over the last years. This program is available to all U.S. based firms that have experienced a decline in sales and employment due to import competition.

The program is available within all US States. Each US State has its own TAA Grant Administration office, responsible for collecting and managing all applications of firms for the grant program.

Three Phase Application

The program is divided into three easy consecutive application phases:

  • Phase 1 – The firm is certified into the program. There is no cost for the firm to get certified.
  • Phase 2 – This phase includes the development of the diagnostic analysis and adjustment plan, in which a suitable implementation project is defined.
  • Phase 3 – is the project implementation phase, in which the firm can start implementing the project with an implementation partner and the local TAA office. The allocated grant will be used to fund the project.

Application Procedure

For certification, your implementation partner will help you to build a petition based on your financial and employment data (two years), along with some other very basic information. Petition development can go very quickly (a few days) once all the information is available. Designated project application support will be provided by the TAA local office in your state.

After acceptance of the petition by the TAA Office, (about 60 days from receipt of the petition), an official company visit is required to clarify details and determine eligibility.

From that point, the implementation partner prepares an “Adjustment Plan (AP),” which goes to the TAA local office for internal approval. The AP cost depends on the firm revenues, but ranges from $3,000 to $12,000, with the TAA picking up 75% of the total AP cost. The maximum cost for the firm is $3,000. Once the AP is approved, the project implementation phase can start.

Funds up to $150,000 can be used for growth projects that are outlined in the AP. Funds are available on a 50/50 cost-sharing basis, depending upon the firm’s sales volume / size (i.e. the firm pays $75K and the TAA grant program pays $75K at a cap amount of $150K in project assistance for firms with over $3 million in sales).

The TAA grant program foresees also a mini-plan for smaller firms – around $1 million in sales – which caps project funds at $30K, but the program pays 75% of that total project cost. It is recommended to request support for application from your implementation partner.

The TAA Adjustment Assistance Program does not pay for any kind of asset purchase (machines, software, etc.), but pays for asset-related projects, such as software modification or implementation, ISO 9001 implementations, etc. They also cannot pay for off the shelf software or modules, and cannot pay firm’s employees. Outside those few limitations, the program generally pays for the partner implementation work. Firms must complete any approved project every six months (from the date of AP approval for the first project) in order to stay in the program and get the matching funding on re-occurring basis every year. In a recent change, firms are now required to complete the program within five years after their adjustment plan is approved.

Once the implementation program contract is signed, the implementation project can start. Local TAA offices encourage monthly billing, to ensure the client is satisfied with the results. The implementation partner bills half of the implementation cost to the responsible TAA local office and the other half to the firm. The program does not allow any direct payment to the implementation partner.

Application Requirements

  • Employees data
  • Production Employees
  • Total Net Sales
  • Sales from Purchased Finished Products for Resale
  • Sales for Exported Products

Firms must make sure employment numbers match the State Employer Quarterly Reports.

Production employees are employees that work on the import-impacted products.

Please make sure your net sales information matches your financial statements.

 

Please contact us for more information

BPA Quality ISO 9001:2015

The need to comply with customer’s demands and regulations is increasingly challenging for managers and executives. Complex risk(s) and quality management obligations must be observed (and or monitored) on a daily basis down to the affiliate levels. Noncompliance can hurt any organization’s bottom line, market position and corporate image.

The latest edition of the ISO 9001:2015 has just been published in September 2015 and takes care of these new challenges.

BPA developed an all-in-one quality + risk management solution to help organizations registering or renewing their ISO 9001 certificate and be compliant with the 2015 release.

More than 50 quality processes have been described with their purposes (or objectives), inputs, outputs, activities, indicators and needed compliance documents. The core process map gives an overview of the key processes.

 

Strategic Planning

 

BPA Quality ISO 9001:2015 gives answers to the new ISO requirements, like considering your stakeholder’s expectations and determining your quality strategies such as competitive intelligence.

Market

 

New quality tools have been integrated like SWOT analysis to better support your strategic decisions and business opportunities.

 

 

Risk management is now required by the ISO 9001:2015 standard. Risk management is the preventive way to avoid nonconformities. 60+ high level risks have been identified and are ready to be assessed periodically using our scorecard component.

 

Auditing is a powerful tool to check for any process compliance. 100+ audit questions grouped by ISO 9001:2015 clause and chapter will help you planning your internal audits. The audit question library contains another set of questions to help your organization qualifying and evaluating suppliers. Key suppliers are periodically evaluated using scorecards.

 

Prebuilt workflows will drastically reduce time to handle your quality processes. The 8D non-conformance/CAPA workflow makes sure you go through the main steps to build your team, describe the problem, investigate root causes, declare corrective/preventive actions and measure their effectiveness. The 8D CAPA report is generated on the fly and can be emailed to your stakeholders from the system.

 

Knowledge is one of the most important asset in your organization. ISO 9001:2015 requires to develop, maintain and retain knowledge in your company. BPA introduced a wiki system to sustain your knowledge management initiatives.

 

Contact us to learn how BPA Quality will help you registering or renewing your ISO 9001:2015 certificate and guide your organization to Excellence.

Best Sharepoint finalist 2015

BPA Quality is Best SharePoint Solution Finalist at ESPC 2015

>> Vote Now for BPA and Win a Samsung Tablet (click Login or Register and select BPA as your favorite to participate in the competition)

We are honored BPA Quality was named Best SharePoint Solution Finalist at European SharePoint Conference 2015.

Among BPA voters, one will be selected to win a Samsung tablet. The winner will be announced during ESPC and the tablet will be sent to the winner.

>> Vote Now for BPA and Win a Samsung Tablet (click Login or Register and select BPA as your favorite to participate in the competition)

>> Read our eBook

Regulatory 2015

Multi Site Quality Management System

BPA Quality is the ideal tool for a multi site quality management system solution. The app can be downloaded from the Microsoft store and instantly deployed to all facilities, plants, departments of your group of companies. Policies, procedures and good practices can be shared with all affiliates on a group-level site. Processes related to specific plants will be deployed on related sub sites (e.g. plant specific audits, compliance documents, risks…). Consolidated data allows your group of companies to continuously improve performance of your affiliates.

This use case scenario applies for the following scenarios:

  • A group of companies ensures compliance for each affiliate
  • A company shares processes with external stakeholders (suppliers, clients…)
  • A consulting/regulatory office ensures compliance for their clients

In this example a group of companies want to share regulatory content – e.g. identified risks, requirements, SOPs, compliance documents – with their affiliates/subsidiaries/clients.

In the root site, the group of companies can view consolidated risk information – or any other consolidated data – for all affiliates, grouped by territory.


BPA Regulatory 2015

 

High risks – based on impact and probability values – are highlighted in the risk section. Main risks can be shared with affiliates.


BPA Quality & Risk

 

Each affiliate has a private and secure quality site (instance) where risks will be controlled and mitigated.


Risk Details - Controls

 

Company-wide regulatory content is shared with affiliates through replication rules.


BPA Replication

 

Group compliance documents are centrally managed and accessible by any affiliate.


Compliance Documents - document links

 

Each affiliate has a dedicated subsite to periodically assess risks, set controls, manage corrective actions and store documents. Important data will be consolidated on the group-level site.


Risk

Conclusion

BPA Quality is the ideal tool for groups of companies – company holdings, regulatory offices, professional associations – to improve performance of their affiliates, subsidiaries, stakeholders.

Benefits for the group of companies: ensuring compliance for each affiliate, simplify regulatory and compliance for the whole group.

Benefits for affiliates: a dedicated compliance platform is not necessary, regulatory content is managed by professionals, attractive pricing, simplified audit process and improved compliance.

Benefits for consulting offices: differentiation of the offered services, recurring source of revenues, possibility to offer new associated services with the platform (e.g. compliance audits which will be much easier with the tool), modern image, etc.

ISO 9001:2015 What will be the impact on your company?

BPA has recently participated to a seminar about the new ISO 9001:2015 revision. Here are some key points.

The new ISO 9001:2015 revision should be published in September 2015. The latest revision was completed in 2008.

The main objective is to integrate all ISO standards and improve the ISO 9001 standard adoption for any sector.

Revisions for the main processes. We now have 6 main processes in ISO 9001:2015:

  • Leadership
  • Planning
  • Support
  • Operations
  • Performance evaluation
  • Improvement

The aim of the new planning process is to determine risks and opportunities, to set objectives and to identify action plans related to risks.

Leadership, risk governance, process performance measurement, innovation and stakeholder management are key points of the new ISO 9001:2015 revision.

ISO 9001:2015 processes

Image: ISO 9001:2015 processes

BPA Solutions has developed an integrated software for Quality + Risk management compliant with the new ISO 9001:2015 revision.

Our business experts can guide you implementing tailored solutions to match your needs + ISO requirements.
>> Ask for a trial now