Using Your QMS For Your Company

Using your QMS

Using Your QMS for your company, this is critical to it being effective!

Please remember that your Quality Management System should be designed to improve your processes and improve the satisfaction of your customers.  It is up to your management team and senior leadership to identify the strategic direction of your company and align the QMS to meet the goals that you need to achieve to move your company forward.  Your certification body quality auditors are there to identify problems, and they may identify some opportunities for improvement, but the QMS is not there to satisfy them.  Using your QMS must suit your needs, make sure it works!

If you are looking for more guidance on how you should be using your QMS in a more profitable manner, there is a guidance standard: ISO 10014 – Quality management — Guidelines for realizing financial and economic benefits, which is available to help you with improving the return on investment for your ISO 9001 implementation.  So, when you are addressing the requirements of ISO 9001:2015, think about each element of your Quality Management System as you implement each process and determine how you can use this process to become more profitable.  You will quickly find that if you are using your QMS with business profitability in mind, there are many more elements of the interrelated processes that work toward better profitability besides the four main processes – you just need to find and capitalize on them.

“What’s in it for me?” is not an unreasonable question for anyone to ask, especially if you are going to ask them to spend money.   If you want your business to invest in a Quality Management System (QMS) such as ISO 9001:2015 you should have some idea of what it is going to cost you and how much you will get back for your investment.

ISO 10014 Quality Management Guidelines for realizing financial and economic benefits

It provides guidelines for achieving financial and economic benefits from using your QMS with the Eight ISO 9000 Quality Management Principles:

  1. Customer focus
  2. Leadership
  3. Involvement of people
  4. Process approach
  5. System approach to management
  6. Continual improvement
  7. Factual approach to decision making
  8. Mutually beneficial supplier relationships

Like ISO 9001, ISO 10014 requires the involvement of top management and works in conjunction with ISO 9004 for performance improvements. It provides examples of achievable benefits and outlines tools to realize them.   Using your QMS with a PDCA based improvement cycle can help employees better utilize the system.  The PDCA diagram should display each quality management principle that lists activities for each Plan-Do-Check-Act stage.  The eight examples (listed above) provide outputs for each QMS principle which provide benefits to the organization.

USING YOUR QMS
PDCA Cycle

Economic benefit – Improved processes usually result in better resource management, improved customer relationships, and the overall worth of an organization.

Financial benefit – A direct result of organizational improvement expressed in financial terms and realized by cost-effective management practices.

CVG Strategy Experts

Our Exemplar Global Lead Auditor Consultants can help you with implementing a quality management system, which will include a risks and opportunities procedure.  CVG Strategy has prepared, trained and implemented quality management systems for manufacturing companies in the past 10 years.

CVG Strategy is a consultancy offering coaching, mentoring, training and program development focused on areas including Business Process Improvement, ITAR and Export Compliance, Cyber Security and Product Test and Evaluation.  For any additional questions, please contact us now!

Corrective Actions – Make them Work For You

Corrective Action Check Mark Box Fix Problem Repair 3d Render Illustration

 Corrective Actions provide Opportunities for Improvement!

One of the most overlooked areas of the QMS for increasing profitability is to implement a process to control corrective actions. Some business leaders see this process as unnecessarily complicated and time consuming, but this is often because it is excessively used on small problems that do not need a full root cause analysis and complex correction procedure. It is worth a second look at how you can make a corrective actions system work to help you find improvements.

If you could take your biggest operational issues, identify the root cause of those problems, and then find a way to make sure the problem does not happen again – think about the cost savings you could realize.  By making sure that a corrective actions process is focused on finding real solutions to the problems that cost you money, and effectively addressing those problems so that they do not happen again, you can find the cost savings and profitability you want from your QMS.

Corrective actions are reactive – something has gone wrong and these are the actions taken to deal with the problem.  Non-conformances are resolved through corrective actions.  This will include the immediate corrective actions you take to keep your customer happy, e.g. you sent the wrong part and will immediately replace it with the correct part.  However, ‘dealing with it’ for ISO 9001 means that you eliminate the problem and make sure it will not happen again.  So the corrective actions you take will also include the longer term actions you take to make sure the problem will not occur again.

The problem might be identified in processes, materials, suppliers, the product, the service, the workplace, or the management system itself.

You might find opportunities for corrective actions through:

  • audits (internal and external)
  • consulting with staff
  • customer feedback
  • hazard reporting
  • inspections – workplace opportunities
  • investigating complaints
  • resolving non-conforming products or services
  • reviewing system failures
  • reviewing regulatory requirements
  • testing, inspecting, and monitoring of plant and equipment

CVG Strategy Experts

Our Exemplar Global Lead Auditor Consultants can help you with implementing a quality management system, which will include a risks and opportunities procedure.  CVG Strategy has prepared, trained and implemented quality management systems for manufacturing companies in the past 10 years.

CVG Strategy is a consultancy offering coaching, mentoring, training and program development focused on areas including Business Process Improvement, ITAR and Export Compliance, Cyber Security and Product Test and Evaluation.  For any additional questions, please contact us now!

Opportunities for Improvement – Internal Audits

Opportunities for Improvement

Opportunities for Improvement are tied to effective Internal Audits and Management Review.

Companies must strive to identify Opportunities for Improvement in many ways, the biggest opportunity is through its Internal Audit with a critical review in the subsequent Management Review meeting.  Many in management view their internal audit program as a waste of resources that simply takes up the time of employees who would be better spent doing their jobs.  Nothing could be less far from the truth, if the internal audit program is used properly.  The idea of your internal audits is to have an objective and impartial person look at the outputs of the processes to ensure that these processes are meeting the planned arrangements that were set out for the process. The audits also provide information on the effective implementation and maintenance of the QMS.

By taking the opportunity to take an impartial look at a process, your internal auditors can identify problems that could go unnoticed during day-to-day activities.  In addition, they will be able to identify issues with the linkages between processes that can cause inefficiency and identify opportunities to improve the overall effectiveness of the QMS.   Evaluating and taking action on improvement opportunities makes your company better and can lead to cost savings and better profitability.

Opportunities for improvement exist in every company, in every job, in every workflow. Organizations that recognize this fact and engage their entire workforce in identifying those opportunities work to create a culture of continuous improvement. By engaging front-line workers in improvement efforts, organizations are able to improve on a more granular level than is visible to managers and senior leaders.

Whether they are part of top-down initiatives or bottom-up daily improvement, it’s important that each be accelerated through the improvement cycle as quickly as possible.  In this way, successful organizations are able to sustain momentum and increase engagement in continuous improvement.

CVG Strategy Experts

Our Exemplar Global Lead Auditor Consultants can help you with implementing a quality management system, which will include a risks and opportunities procedure.  CVG Strategy has prepared, trained and implemented quality management systems for manufacturing companies in the past 10 years.

CVG Strategy is a consultancy offering coaching, mentoring, training and program development focused on areas including Business Process Improvement, ITAR and Export Compliance, Cyber Security and Product Test and Evaluation.  For any additional questions, please contact us now!

Quality Objectives – Use to Drive Improvements

Quality Objectives

Quality Objectives must be established for your QMS and be measurable and reasonable for your company.

The use of quality objectives to drive improvement is not new to the ISO 9001:2015 requirements.  Quality objectives, which are one of the best ways to focus the improvement activities within your company, have been included in the QMS since the ISO 9001 update that happened in 2000.  These objectives are your way of identifying what aspects of quality management and customer satisfaction you have chosen as your main improvement aims, with reasonable and timely targets, so that you can make plans to make these improvements and move your company strategy forward.

Quality Objectives – Details

The quality objectives are the main method used by companies to focus the goal(s) from the Quality Policy into plans for improvement. The Quality Policy is created with the Customer Requirements in mind, then quality objectives are linked back to the Customer Requirements through the Quality Policy.  Quality objectives take the goal(s) stated in the Quality Policy and turned these into statements for improvement against which plans can be made.

For example, if the Quality Policy of an aerospace manufacturer had identified a customer need for just-in-time delivery with no defects as the most important requirements, the goal from the Quality Policy might read: “To deliver whatchamacallits to our customers when they need them, with no defects, every time.”  This company might then have two Quality Objectives: the first being to address improvement of on-time delivery, and the second to address defective parts shipped to the customer.  The first objective might be: “to improve on-time delivery from 90% to 95% within the next year” and the second could be: “to reduce field escapes to the customer from 4% to 3% within the next year”.  In doing so, the improvement derived from the Quality Objectives is directly linked to the needs of the customer.

These quality objectives would then be communicated to each level of the organization with corresponding quality objectives and plans at each level to help meet the overall planned goal.  If your company uses a Balanced Scorecard, this is a good format to use for this communication of quality objectives.

The quality objectives need to be set for the different levels of the organization right down to objectives for the product (e.g. one objective for the whole QMS, then individual objectives for the product or process that supports the overall objective). These product or process objectives are often referred to as Key Performance Indicators (or KPIs).  By utilizing the KPIs that the company has identified as the important indicators that the processes are functioning well the overall QMS quality objectives for improvement become much easier to measure.

CVG Strategy Experts

Our Exemplar Global Lead Auditor Consultants can help you with implementing a quality management system, which will include a risks and opportunities procedure.  CVG Strategy has prepared, trained and implemented quality management systems for manufacturing companies in the past 10 years.

CVG Strategy is a consultancy offering coaching, mentoring, training and program development focused on areas including Business Process Improvement, ITAR and Export Compliance, Cyber Security and Product Test and Evaluation.  For any additional questions, please contact us now!

Risks and Opportunities – Making Plans to Address

Diagram showing risks and opportunities

Risks and Opportunities are managed on a daily basis at every company.

Everyone evaluates risks and opportunities every time they make a decision.  It is all about weighing the probability of a positive outcome versus the impact or cost of a negative outcome from an action taken.

An addition to the ISO 9001:2015 requirements, compared to previous versions of ISO 9001, is to understand and take action to address the risks and opportunities for your QMS.  This can be done however you want, and many companies will perform a SWOT analysis as a way to identify business strengths and weaknesses, but the important factor in realizing profit is deciding what actions you will take.  A SWOT or Strengths, Weaknesses,

By identifying the risks and opportunities that are applicable to your company, and deciding what actions you will take, if any, to address these, you will be able to find ways to limit the negative impacts of potential problems and also capitalize on the opportunities that can lead you into new sales markets or product lines. Properly acting on risks and opportunities can realize great profit for your company and help resolve a fundamental requirement in ISO 9001:2015 for “risk based thinking”.

Risks and Opportunities play a role in continual improvement and should be “plugged in” to your regular improvement processes where specifically enumerated in the ISO 9001:2015 standard.  Prior to approving and implementing a quality plan, corrective action, non-conformance, design and development plan are all areas that require “risk based thinking”.  These quality processes (and more) are required and used by most companies who apply a formal and organized risks and opportunities procedure.

CVG Strategy Experts

Our Exemplar Global Lead Auditor Consultants can help you with implementing a quality management system, which will include a risks and opportunities procedure.  CVG Strategy has prepared, trained and implemented quality management systems for manufacturing companies in the past 10 years.

CVG Strategy is a consultancy offering coaching, mentoring, training and program development focused on areas including Business Process Improvement, ITAR and Export Compliance, Cyber Security and Product Test and Evaluation.  For any additional questions, please contact us now!