Quality Management Dos and Don’ts – Don’t be guilty of being in the red

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1. Meet Customer Requirements

Surprisingly there are companies that want ISO 9001 certification just to satisfy one customer requirement. The customer states that it will only do business with vendors that are certified as ISO 9001 – so to get (or keep) the business they need that certification. The problem with these companies is that they’re looking for a short-term payoff and an end to the journey with a certificate. They see nothing but that one benefit — we need a certificate for this customer — and ignore the long-term benefits a robust quality management system will provide, like:

  • Less firefighting;
  • Fewer repeat problems when you perform better root cause analysis and systemic corrective actions;
  • Increased performance because you’re monitoring trends against goals;
  • More efficient and effective business processes;
  • Less scrap, rework, rejects, warranty; and
  • Increase customer satisfaction leading to more business opportunities.

Some organizations don’t embrace the concept of quality linked with the business systems and tied into the strategic direction of the company, to drive continual improvement and continued customer satisfaction. In other words, they haven’t bought into the program or the true intent of the standard.  Focusing only on that one benefit — your immediate gain — without putting the customer in front will end up costing you much more in the long run.

2. Increase Revenue and Business from New Customers

Once you earn your ISO 9001 certification, you can advertise your quality certification and respond to Requests for Quotes (RFQ) from companies that make ISO 9001 certification a “must-have”.  ISO 9001 certification can open up new markets you were virtually unable to do business with before your certification.

Yet, companies are not advertising their ISO certification enough, costing them potential business. Transition or implementation of a new standard is the perfect time to share that the company has achieved this important recognition with your potential customers, current customers, and stakeholders. Consider a link to a copy of your ISO certificate right on your website.

3. Improve Company and Product Quality

quality management system standard is all about quality so, of course, one result of adopting a QMS should be an improved level of quality for the entire organization — every process, and every product. Organizations should use the ISO series of standards to develop a QMS that is integrated into the way they do business, and assist in achieving their strategic business objectives – adding value.

Unfortunately, some organizations may have missed the mark and created a bureaucratic set of procedures and records that don’t reflect the reality of the way the organization actually works and simply add unnecessary costs, without adding value. When the business system is the same as the quality system processes, the value of ISO and certification become more logical and value-added for the business.

4. Describe, Understand, and Communicate Your Company Processes

The ISO 9001 QMS standard requires that you identify and describe your processes using business metrics, the purpose of which is to better manage and control your business processes. Quality objectives or your business process goals form the center of your system. Metrics are used to understand and communicate your system’s performance and trends relative to your quality objectives. The level of monitoring, measurement and improvement of each process will depend on the organization’s context, strategic intent and determined risks and opportunities.

Companies may identify too many processes. So it is important to understand the differences between a process, a procedure and an activity. We recommend less than 10 core processes, and fewer is commonly better.  Looking at your business from a 50,000 foot view to understand the high level business processes needed to deliver the products or services you provide your customers are the core processes ISO wants you to define.  Everything from sales, to new product development, to production planning, to production or providing a service, and finally delivery are the processes to identify for your business.  A flow diagram is most commonly used with the linkages and interactions between each.  Each of these core processes needs to have at least one objective that is measured to evaluate the effectiveness and efficiency of that process. Problems can also occur when companies don’t have set metrics on which to evaluate processes and manage the control of their business processes.

The International Organization for Standardization (ISO) has created a useful whitepaper to explain the Process ApproachContact simpleQuE to see how our consultants can assist your company with these problems or other areas of concern.

 

 

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The Benefits of Working with a Management System Consultancy

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Ultimately companies hire a management consultancy firm like simpleQuE to save both time and money. Working with experienced professionals can help businesses achieve their objectives quickly and avoid costly mistakes along the way. And thanks to their specialized knowledge, quality and environmental management consultants can help innovate, improve and enhance organizations at every level.

Businesses of all sizes seeking to outperform their competitors and stay at the top of their industry are increasingly choosing to work with QMS and EMS consultants. When selecting a consultancy, they’re looking for someone who can provide tangible results and a clear return on investment. The best consultant-client relationships are based on clarity and transparency, where both parties have set clear roles and expectations and put in place a system to effectively measure results.

Management consultants help organizations improve their business by analyzing their systems and processes and developing plans to help them improve. Whether it’s preparing for first time certification, upgrading to a new standard, simplifying cumbersome quality systems and documentation, or defining processes and process mapping, simpleQuE can help.

Each management consultancy offers different specializations and simpleQuE’s consultants are proven experts in their respective fields. We bring experience from all sides of the table—third party auditor, business owner, management representative, implementer, facilitator, project manager, etc.—in areas including general manufacturing and service, automotive, aerospace, environmental and safety.

After performing a gap analysis, we offer customized solutions for each client we work with. Our strength is in evaluating and understanding your business and culture to find the solutions that will be most efficient and sustainable over time. We’re known as the consultant that simplifies ISO implementation and maintenance.  And simpleQuE is even ISO 9001:2015 certified – proof that we practice what we preach.

No company is exactly the same, and every company’s needs for certification are unique as well. At simpleQuE, we tailor our approach closely to your specific needs and deliver exactly the consulting, auditing and training services your company requires. Our approach eliminates confusion and ensures your company is investing only in the work that is required for certification. Contact us to see how we can add value to your business!

ISO 9001 Myths and Their Reality

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ISO 9001 is the world’s most used management system standard, existing for almost 30 years, it tends to fall into the gap where many people have heard about it, but not many fully understand what the standard involves. As a result, there are common myths about ISO 9001 that simpleQuE can help to clarify.

Is it complicated and difficult to implement?
In most cases, no. SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified, so we know what it takes to transition to the new standard. It is possible to simplify ISO implementation, transition, training and maintenance, by integrating simple solutions that fit into your company’s culture.  This can be done with a gap audit checklist to identify where you’re already in compliance and more effectively target only those areas that need work.

Isn’t ISO 9001 an outdated model?
While it is true that ISO 9001 has been around since 1987, it has evolved through several revisions to match the changing needs of business. Today there is instant access to information, higher expectations from customers, more complex supply chains and a globally competitive economy.  ISO 9001:2015 takes all of these factors into account.

Isn’t ISO 9001 a standard that only benefits big corporations?
This is not the case. ISO 9001 is intended to be a set of requirements that can be used by any company, of any size, in any industry. The requirements are written as a set of best practices needed to control all the processes of a business system – no matter what the company does. The standard is designed to be flexible; the focus is on improving quality and customer satisfaction, which every organization can benefit from including:

  • More efficient use of resources and improved financial performance,
  • Improved risk management and protection of people and the environment, and
  • Increased capability to deliver consistent and improved services and products, thereby increasing value to customers and all other stakeholders.

Will everything have to be monitored and measured?
Processes do have to be monitored and measured to ensure that they are performing as designed, however, the standard allows a company to consider the impact that a process has on product/service conformity and the effectiveness of the Quality Management System (QMS) when determining what to monitor or measure and the method to be adopted.  A good QMS will help with monitoring performance and driving improvement.

Is ISO 9001 is the sole responsibility of the quality manager or department?
This couldn’t be farther from the truth, since the requirements cover every aspect of the business – from planning through delivery and post-delivery of your product or service.

Doesn’t ISO 9001 cost a lot to implement?
The question of cost will depend on the size and complexity of the organization and the competency of the personnel. Basic implementation pricing should be competitive and reasonable, depending if the work is done internally or through an external consulting service. The overall outcome of these activities should be to reduce costs through improvements and increase revenues through satisfied customers. Your return on investment should be well above the costs. Note that ISO certification is a separate additional cost.

SimpleQue can customize consulting for your organization and provide simple solutions while clearing up any misconceptions about ISO 9001 and how it can benefit your organization. Contact us today to find out more information and how simpleQue can help!

ISO/TS 16949:2016 – Shifting into High Gear

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SimpleQuE representatives were recently invited to attend the Eagle Certification Group auditor training, which included the latest information on anticipated changes to ISO/TS 16949:2016, and they are significant!  In May, Eagle participated in 4 days of meetings in Italy with all the stakeholders to provide feedback on the final draft TS standard to be released Q4 of this year.  Get ready because the changes will greatly impact automotive suppliers and the industry!

Here are some of the significant changes we learned are in the TS final draft, which is still subject to change.  But due to this late date, we anticipate many of the revisions are realistically coming, along with some unexpected new requirements.

  • A new layout to 10 clauses to include all of ISO 9001:2015.  Get a copy of this standard and begin compliance to the ISO changes, as they will be in the new TS standard.
  • Harmonization of the Customer Specific Requirements within the TS standard, along with the core tools requirements. 
  • A new requirement for a documented process on Product Safety. It should include the identification of regulatory and customer requirements affecting safety, along with approvals for changes, customer notifications/reaction plans, special approval of control plans and PFMEA’s, specific training, and flow down of product safety requirements down the supplier chain.
  • A new clause on Corporate Responsibility – in light of the problems with the VW emissions scandal and Takata airbags. There needs to be an escalation policy (which includes whistle-blowing) to improve integrity in social and environmental matters.
  • A greater emphasis on process effectiveness and efficiency, with the need for management reviews to include process performance review.  A rule that went into effect this year for certification bodies is that if processes are not performing effectively and efficiently and corrective actions taken by the company are not effective in a subsequent audit, the certification body is to write a major nonconformance.
  • For plant, facility, and equipment design and layouts, a cross functional team is required, along with risk identification and risk mitigation techniques. This includes manufacturing feasibility prior to, and ongoing evaluations after start up, for maintaining process effectiveness and updating of documentation (control plans, job set-ups). This is also a new input to management reviews.
  • A new requirement for customer-specific training as it may relate to customer portals and the communication of information to and from the customer (orders, releases, ASN, PPAP, corrective actions, etc.).
  • A process must exist for determining and ensuring training needs for employees working with the customers during the quote, project development and production phases.  As appropriate, these employees must be trained in APQP, Customer Specific Requirements, FMEA and Control Plans.
  • A new focus and attention on embedded software as part of the design and development process (i.e. engine control modules, emission control systems, etc.).  It also has its own clause outside of design, which requires a process for software quality assurance and the use of Automotive SPICE (Software Process Improvement and Capability Determination). A SPICE assessment or audit is also required prior to PPAP.
  • Supply chain risk for quality and delivery is a new requirement for consideration in supplier selection.  This may include financial stability, volume of automotive business, change management process, business continuity planning, and more.
  • Total Productive Maintenance is a new clause requiring documented maintenance goals that include at least OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure) and MTTR (Mean Time To Repair).  These also are now inputs to Management Reviews.  When objectives are not met, there must be a documented action plan to address corrective actions.
  • Companies need to identify manufacturing processes and error-proofing devices that can be bypassed.  Based on risk and FMEA severity, bypass procedures must be developed, and may require customer approval.  Bypasses must be reviewed daily with focused audits, with daily leadership meetings to reduce or eliminate bypass operations.  Restart verification is required when no longer bypassing.
  • Non-conforming product that is scraped must now be physically rendered unusable prior to disposal.
  • There are new flow-down requirements to suppliers and external providers of products and services, which include cascading down the supply chain for regulatory/statutory requirements and special product and process characteristics. 
  • Gauge calibration clearly includes monitoring and measuring equipment required to ensure effective control of manufacturing processes. 
  • Internal audit requirements are enhanced with clear annual plans for the QMS, manufacturing process, and product audits.  The number of audits and audit days must be specified and planned.  A risk based approach needs to be utilized to prioritize the audit program, based on customer issues, performance trends, and criticality of the processes.  Software development capability audits are also required.
  • A process must exist to ensure internal auditors can demonstrate competence to audit TS, manufacturing processes and products, core tools, relevant Customer Specific Requirements, and more.  There are also trainer requirements that must be met. Approved auditors must be documented and competency monitored through conducting of a minimum number of audits per year (as defined by you).
  • Management review inputs are expanded by ISO 9001:2015 and the new TS standard, and include new topics of warranty performance, maintenance action plans, etc.  Clear action plans must exist when customer requirements are not met.
  • Warranty management is a new clause, requiring a process that also includes warranty part analysis and “no trouble found”.
  • All customer complaints and field failures (including returned parts) must initiate formal problem solving and corrective action.
  • TS will add back the requirement for Preventive Action.
  • A documented process for continual improvement is required.

SimpleQuE offers quality management system consulting, internal auditing and training for Automotive, Aerospace and other industry standards.  Contact us to learn more about transitioning to ISO/TS16949:2016.