November 9th is World Quality Day, and today’s theme is “Celebrating Everyday Leadership”. So to celebrate leaders of all kinds, our infographic below features five qualities that all effective leaders should possess.
VEGA Americas‘ management takes a creative and fun approach to preparing for an ISO audit of their Quality Management System. They are a global manufacturer of level and pressure instrumentation for the process industry. VEGA’s COO John Kronenberger plays the character ISONO, who isn’t sure what to do in some audit situations like this one where simpleQuE Consultant, Don Milinkovich plays the role of auditor while Quality Manager, Gretchen Lisi, looks on. They give suggestions on their intranet on how to be an ISOPRO – a great way to communicate internally and create awareness* among their employees. Way to go team VEGA!
*ISO9001:2015 Clause 7.3 Awareness
The organization shall ensure that persons doing work under the organization’s control are aware of: a) the quality policy; b) relevant quality objectives; c) their contribution to the effectiveness of the QMS, including the benefits of improved performance; d) the implications of not conforming with the QMS requirements.
Whether facing a surveillance audit from a certification body or preparing for an internal audit – knowing what you face and being prepared puts you a step ahead. Review this checklist which covers the majority of the QMS requirements.
1) Who or what are the:
- Process Owner
- Personnel Interviewed
- Documentation Reviewed
- Records Sighted
2) What are the resources needed for the process?
3) Are these resources appropriate?
4) Are authorities and responsibilities for required resources defined, documented and known
throughout the organization?
5) Are these persons competent?
6) Are competency criteria defined? What are these criteria? How is competency evaluated,
approved and monitored, and by which method(s)?
8) Are these methods effective? – refer to outputs
9) Are the resources adequate? Which are they?
10) Are records available and appropriately maintained?
11) What are the inputs to this process?
12) Are these inputs documented and reviewed by competent persons?
13) Is a description of the processes available and documented?
14) Are these descriptions controlled? – Verify the effectiveness of the organization’s
documented information control procedure.
15) Who are the “customers” (internal and external) of the processes?
What are the requirements of these customers?
17) What are the characteristics of the intended results of the process?
18) What are the characteristics of the unintended results of the process?
19) Are correction and corrective action applied as appropriate?
20) What are the criteria for monitoring, measurement and analysis?
21) How are these criteria incorporated into the planning of the processes?
22) Are the business performance issues taken into proper account?
23) What methods are used for data gathering?
24) What records are kept and how these are maintained?
25) What are the communication channels?
26) How is external and internal information about the process provided?
What are the outputs of the process? – Identify outputs.
28) Do these outputs provide evidence of effective implementation of the process?
29) How is process performance monitored?
30) Are appropriate controls defined?
31) What measurements are applied?
32) How is the gathered information analyzed?
33) How are the results of the analysis taken into account?
34) How is feedback obtained?
35) What data is collected?
36) Is the issue of improvement of the processes properly addressed? How?
What are the results?
Source: Eagle Certification Group – 2017 Annual Bootcamp/Conference
SimpleQuE offers free sample manufacturing process audit checklists for AS9100, ISO 9001 and IATF 16949 which can be used as an example to examine a company’s key manufacturing process and prepare your company for the highest quality internal auditing possible.
Links to Sample Manufacturing Process Audit Checklists:
At simpleQuE it’s not just our name that represents quality excellence, it’s our unique combination of consultants, knowledge and expertise. We believe in serving our clients before, during and after the certification process. This value added service consists of an ongoing education process on the quality standards through our website, newsletters social media, and blog. Each month, we provide updates on the latest news from the ISO, AIAG, ASA, IAOB and IATF standards community, and what we’re is seeing in the industry.
In a year that will be filled with companies scrambling to upgrade their certifications, we feel it’s even more important to stay informed. That is why we encourage anyone who is currently not receiving our monthly newsletter to sign up today. And if you’re still on the fence, here are our top five reasons:
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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
A 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 Approach. Contact simpleQuE to see how our consultants can assist your company with these problems or other areas of concern.
Stelfast is a family owned and operated company, which began operations in 1972 as a small and progressive manufacturer of industrial gears and screw machine products. Seeing the need in the market for a reliable and quality oriented fastener company, Stelfast incorporated in 1976 and today is a leading importer; stocking master distributor of fasteners and specialty parts from Asia, Europe, and South America; and manufacturer of truck and specialty fasteners. With a knowledgeable and dedicated team of employees, Stelfast has expanded to include an automotive division and ten regional distribution centers across North America.
As evidence of their commitment to quality, the Stelfast Quality Control Department, based in Strongsville, OH, is responsible for all of their branches to ensure conformance to customer requirements. The ISO-9001 certified facility includes a Quality Lab with measurement and testing equipment specifically used for fastener inspection and testing.
When it was time to upgrade to ISO 9001:2015, Stelfast turned to simpleQuE consultant, Jen Briese to provide certification support and guidance for implementation and improvements of the quality management system. This included a full system internal audit, in preparation for their external surveillance audit. The end result – Stelfast is now ISO 9001:2015 certified!
The quality department is also responsible for maintaining all suppliers certifications, which are kept on file for customers to meet dimensional, material and mechanical properties as required by specifications and customer requirements. Stelfast Quality also performs internal audits to assure compliance to their own strict quality guidelines. PPAPs are generated to meet both AIAG and customer specific requirements. At Stelfast, customer satisfaction is priority one and the Quality Control Department helps to assure that this happens. Stelfast President, Simmi Sakhuja says, “We have a catch phrase around here: ‘GET IT DONE.’ We do everything we can to support our suppliers and satisfy our customers.”
SimpleQuE congratulates the following companies on their successful certification and commitment to quality.
SimpleQuE (an ISO 9001:2015 certified company) assists organizations with implementation, improvement or transition of these standards by providing customized consulting, training and internal auditing services and solutions. Contact us for more information.
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!
Would you like to know what 3rd party auditors are looking for when auditing how your company complies with quality system standards like ISO 9001:2015?
What are 3rd party auditors looking for? This is the second of a three part series by Jim Lee, President of simpleQuE
Clause 5 of ISO 9001:2015 – Leadership
Leadership is the focus of this clause, which means top management now has greater accountability, responsibility and involvement in the organization’s management system. The standard wants to see that leadership demonstrates leadership and support for the quality management system (QMS). They need to integrate the QMS into the organization’s business strategic direction, to ensure the management system achieves its intended outcomes and allocate the necessary resources. Top management is also responsible for communicating the importance of the QMS and enhancing employee awareness and involvement.
With this clause there is a requirement that top management will be present and leading the implementation and monitoring of the QMS. Processes within the QMS must have process owners. In addition, leadership shall demonstrate leadership and commitment with respect to customer focus and the continual improvement aspect of the business. 3rd party auditors will be scheduling time with the management and leadership team asking questions and looking for the items below as objective evidence.
- Established and communicated quality policy, objectives, strategic direction, and performance
- Organizational chart, job descriptions and other evidence that responsibilities and authorities are defined and communicated
- Metrics evaluated in the Management Review and the overall effectiveness of the key business processes
- Actions being taken when goals are not met, and when trends for performance are going the wrong way. They want to see management is looking at the data and taking actions when necessary.
- Promotion of risk based thinking and evidence of risk management processes with action items when risks are too high. This might include contingency plans, safety stocks, inventory levels, supplier selection and qualification process, etc. as a very few of the many possible ways to demonstrate this.
- Involvement in audit activity and reviewing the outcomes and assessing the risks and actions that might be necessary for the QMS
- Customer satisfaction and perception
- Identification of contract terms and conditions and customer requirements, including any laws that must be met. How are these evaluated, understood, communicated and implemented in the departments that need to know and comply?
- Evidence of continued improvement , which denotes that performance is monitored and tracked with trends
- The company’s context changes over time, and the needs of stakeholders too. Management needs to be aware of the changing context and issues affecting the business to adjust the strategic direction.
Not that all of the elements listed above will be needed, but organizations may risk failure if they do not:
- Identify process owners
- Use metrics to monitor performance of the QMS
- Include performance metrics in the Management Review
- Develop action plans when performance goals are not met
- Develop customer communication processes
- Respond to customer complaints
- Consider results of customer feedback/surveys and take appropriate actions
- Identify internal customer requirements
- Make improvement part of the quality policy
- Align roles and responsibilities with processes
- Contingency and emergency roles and responsibilities not defined
- Have appropriate training and awareness of the ISO 9001:2015 requirements
Coming soon – Part 3 and what auditors are looking for in regard to Risk. Also, read more about Context of the Organization in Part 1.
Source: NQA’s Teaming Conference – August 2017
What are 3rd party auditors looking for? This is the first of a three part series by Jim Lee, President of simpleQuE
Clause 4 of Annex SL – Context of the Organization
This is the cornerstone of a management system and the business’ strategic direction. An organization needs to identify internal and external issues that can impact its intended outcomes, as well as all interested parties and their requirements. It needs to document its scope and set the boundaries of the management system to line up with business objectives.
The context doesn’t have to be documented, so 3rd party auditors (as well as internal auditors) will be asking questions of various management members, and looking for these as objective evidence that an organization understands its context and considers all the factors and stakeholders affecting the business. The items listed below don’t have to exist, but if they do, you want to take credit for them in understanding the context. Some items may not by themselves demonstrate an understanding of the context, but combined with multiple examples, can provide the evidence an auditor is looking for.
- Business plan
- Strategic plan
- SWOT analysis (Strengths Weaknesses Opportunities Threats)
- Vision and mission statement
- Process mapping
- External parties identified
- Lesson learned
- Internal meeting minutes to determine company goal setting
- Metrics to measure effectiveness of QMS
- Process turtle diagrams
- Process flow plans
- Quality manual
Not that all of the elements listed above will be needed, but organizations may risk failure if they do not:
- Identify or understand their primary competitors
- Mention civic responsibility
- Consider future business trends
- Identify all customer requirements
- Identify local/state/national requirements
- Identify required outputs needed for internal customers
- Identify uncertainties like negative risks or positive opportunities
- Determine the processes used to flow the business from quote to delivery
- Identify outsources processes
- Establish process goals
Coming in future articles – what auditors are looking for in regard to Leadership and Risk.