Nonconformance Findings

This Month

No events or conferences are taking place due to the COVID-19 environment. Take care of yourself, better times ahead.               

Helpful Links

What We Deliver
  • Operational and Quality Systems
  • Assessments
  • Training
  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
  • Breakthrough Improvement
  • Baldrige Performance Excellence
  • Executive Coaching
Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems include our services ISO 9001 QMS, AS9100 Aviation, Space and Defense, TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards, and more. 
Further subjects include methods of performance improvement such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

Do you have a topic of interest for a subject article in mind? Please let us know.

Certification Nonconformities

We recently attended a webinar conducted by a major global certification body that discussed the top findings found by lead auditors during QMS certification and surveillance audits. These findings would apply to management systems that operate under the requirements of the ISO 9001:2015 Global Standard. If you are not aware, all major QMS standards for example AS9100, ISO 14001, and ISO 13485 include this standard requirements.

The top five findings prioritized were identified for an annual cycle which included:

  1. 8.5.1 Control of production and service provision
  2. 7.1.5 Monitoring and measurement resources
  3. 7.2 Competence
  4. 8.1 Operational planning and control
  5. 7.1.3 Infrastructure
8.5.1 Control of production and service provision
Controls to prevent human error would vary based on the service or product type. This can include fixtures that are put in place or only the necessary tools being available in a work cell. Process monitoring and measuring instructions may be in various formats, such as Process sheets, Shop travelers, Test procedures, or similar documents used by the organization which meet the same intent. The validation methods employed by the organization should include, as applicable, defined criteria for review and approval of the processes, use of specific methods and procedures, and requirements for records.

7.1.5 Monitoring and measurement resources

Documented information can be maintained in a calibration database, spreadsheet, or through certificates. This documented information should include reference to the standards used, the results of any calibration or verification as well as when the resource is found not to be valid.

7.2 Competence

Competence requirements for individuals must be determined and can be defined in job descriptions, training records or similar documents.
The company can determine what is appropriate for a position; however, personnel selected must meet defined criteria. The Standard requires the organization to take action to satisfy identified competence needs. There are numerous methods for accomplishing this requirement. Competence needs should be defined for new employees as well as existing employees. Consideration should also be given to competence of temporary/subcontract employees where appropriate. Regardless of the method used, documented information must be retained.

8.1 Operational planning and control

Most organizations have defined processes, documentation, and other resources for product or service needs. When a new product or service is to be introduced, or an existing product is to be modified, consideration must be given to the need for new processes and resources, or the modification of existing processes and resources to fit the needs of the specific product. If the nature of the activities is not routine, then separate planning for each new order or contract may be needed.

The risks and opportunities that were determined in clause 6 must also be addressed. This could be done through methods such as FMEAs or a control plans. The output of the planning process can be referred to as a “Quality Plan”, “Project Plan”, or similar terminology. However, the specific format for the planning is up to the organization.

7.1.3 Infrastructure

Considerations for infrastructure can such things as:
Offices, production facilities, warehousing, and distribution centers, maintaining production machinery, measuring equipment, and handling and conveying equipment, any information technology required to accomplish the tasks should be identified, including hardware and software needs. Supporting services can include things such as building maintenance, maintenance of production machinery, transportation, communication or information technology support.

In our next issue, we will cover the remaining five documented nonconformances found, including areas of consideration for improving your operational system effectiveness.

Collaborating Partnerships
85% of companies view partnerships and alliances as essential to their businesses, yet only 33 % of them have a formal & clear strategy for collaboration.

Collaborating with business partners successfully is not just about talking to them when there is an issue to be resolved. Rather, it’s a long-term commitment and work ethos that fosters an environment of trust between organizations and people.

From a business perspective, organizations will often seek partners that complement their capabilities to ensure that they meet the expectations of their stakeholders and, at the same time, gain access to new markets. Collaborating in business requires a commitment among parties to co-create opportunities that would lead to mutual and fair benefits for all. A recent study (2018 Global CEO Outlook) conducted by KPMG reports that global CEOs favour strategic alliances as the most important strategy to drive growth, making it an imperative for organizations to learn how to collaborate successfully.

A Management Systems Approach ISO 44001, Collaborative Business Relationship Management Systems – Requirements and framework.  
This standard provides the overall components of a management system for business relationships as well as operational process requirements. It bridges the gap between organizational cultures to form a more robust partnership or alliance, provide confidence to participants and lay a strong foundation for collaboration.
The International Standard features an eight-stage life cycle to ensure a disciplined approach to collaborative relationships which includes operational awareness, value creation, knowledge, internal assessment, partner selection, working together, staying together and exit strategies.
Interested?  You can purchase the ISO 44001 Standard at the ANSI Webstore

Customer Valued Feedback

Customer feedback is a real time process. It needs to be used proactively as an evaluation method to be performed on the way in which your company processes are managed, and its ability to provide meaningful information with which to judge the overall effectiveness of your organization.

We find that our clients often use customer scorecards which provide lagging process information on measures such as on-time-delivery, quality, and customer returns.  These measures do have value, but what are you doing to query your customers with real time information on their current and future needs, dissatisfaction, and what are the reasons you purchase from us?

How does your organization collect data to feed the customer process? There are many ways for an organization to monitor its customers’ perceptions. Some examples of techniques the organization can use include:

* face-to-face visits and evaluations;
* telephone calls or visits made periodically or after delivery of products and services;
* internal inquiries among the organization’s personnel who are in contact with customers;
* other contacts with customers, for example by service or installation personnel.

How is the data analyzed? Simply collecting data on customer perceptions is not sufficient – check how the data is analyzed and what conclusions are made with respect to the effectiveness of operations. 

Are there any trends? Is the situation stable, improving, or deteriorating? Are customer needs and expectations changing? Asking the organization about industry comparisons, or bench marking activities, in order to put customer feedback into perspective can be extremely valuable.  How does the information generated by this process feedback into the QMS as a whole? Organizations should be using the results of the customer feedback process to trigger correction, corrective and/or preventive actions and as one of the overall measures of effective operational performance. 

Lean Times for Improvement
How can your organization take a strategic approach to improve processes during lean times?
  1. Identify the critical processes that produce the most value to your customers.
  2. Communicate with your customers and involve them with defining (or redefining) their needs and wants and adjust your outputs accordingly.
  3. Understand how your processes work.  Dissect your processes and identify the critical variables, inputs into outputs.  For example, people, material, methods, environment, hardware, software.
  4. Establish and/or review the criteria used for the operation of your processes For example, performance metrics related to process outputs, key variables, documentation used, or not used effectively, training effectiveness or lack of training validation.
  5. Use Lean tools and methods to aggressively eliminate waste in these processes.  For example, 5S, value steam mapping, error proofing, kaizen, visual management or kanban.
  6. Follow-up with Six Sigma tools to minimize process variation and improve the accuracy and predictability of your processes.  For example, process mapping, QFD, FMEA, control charts and SPC methods.
  7. Make process improvement a constant within your organization.  Reward people for their ideas and ensure they provide the highest quality product and service. This requires leadership determination and organizational commitment.
In the proactive mode, the organization that recognizes the need to continually improve its processes to meet the challenges of the future, even in these lean times is successful.  Successful organizations understand this – let it work for you and your organization!


In the News

Lean Aids U.S. Hospitals Finances

More than half of public hospitals in the United States have adopted a lean strategy which has led to improved financial performance and efficiency. This is according to a national study published in late 2019 in the Journal of Healthcare Management.

Of the 288 public hospitals included in the study, 54.2% said they adopted lean methods, including daily huddles, plan-do-check-act cycles, visual management and use of standard work.

For more information from this survey visit the Journal of Healthcare Management

Manufacturing Leaders in Sustainability   

More than half of corporations recognized in an index of 100 most sustainable corporations in the world are manufacturing organizations.
The 2020 Global 100 – spearheaded by the Corporate Knights, a financial research and information firm includes 55 manufacturing organizations. For more information on the top 100 corporations visit the Corporate Knights Website.

Training Courses
Due to COVID-19 Virus course scheduling and delivery is currently suspended.  Stay safe. 
All courses can be delivered at your company or at our training centers. We do provide training beyond our home state of Arizona. Click on the course title for description, schedule, registration and payment. Group discounts are available. We also provide custom designed training to fit your specific needs. All training is fully documented for your training records and certificates of training are awarded.
Don’t see a course or schedule that fits your needs?  Contact us.

The near shutdown of the American economy has caused QMS Certification Bodies to rethink how the certification process can be done with limited client resources. This is especially important for those organizations that need to maintain their existing certifications. The information that is coming from ANAB, our ISO technical representative here in the USA, is that Remote Auditing is highly encouraged.

First, understand that your certification body may enact one of two types of remote auditing: Full or Partial. Secondly, some certification bodies (i.e., registrars) will have the ultimate say as to which type will be utilized – not ANAB.

Finally, there are going to be limits set based on the type of certification. Please be sure to contact your registrar for further details and do not hesitate to reach out to us with questions or concerns. 

Best regards, 

Walter Tighe and SES Team
Sustaining Edge Solutions, Inc.
Toll Free 888-572-9642

Leave a Reply