Archive for February, 2018

Identifying Process Nonconformity

Saturday, February 3rd, 2018

 

This Month

 Events
 
PMI Tucson “5S” Pillars of a Lean Workplace. Feb 13, 2018. Walter Tighe Presenter    
 
Lean and Six Sigma Conference
February 26-27, 2018 Phoenix, AZ
 
ISO 9001 World Conference April 4-6, 2018 Las Vegas, NV  


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  • Operational and Quality Systems
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  • Internal Audits
  • Lean Enterprise
  • Six Sigma
  • Kaizen Events 
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Improved Profits and More!

Our newsletters provide information on business management systems and process improvement methods. These systems, our services include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental Management Standard, and others. 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 Subject of Interest for our Newsletter?  Please let us know.

 

ATTENTION Transitioning Organizations: Time is running out! The New Year is here and you have just a few months left to transition to your business requirements new standard. Contact us now for all your gap assessment, onsite training, documentation development and internal audit needs.     

Identifying Process Nonconformity

With all the management system transitioning activities occurring around the globe we thought this is a very appropriate time to discuss what every transitioning company should effectively be doing – Internal Audits.

 
The focus of any management system audit is to determine if the management system has been developed, is effectively implemented and is being maintained. An organization becomes certified on the basis that it has effectively implemented a management system that conforms to the requirements of ISO 9001, AS9100, ISO 13485, or any other global management system. 
 

Internal auditors should maintain a positive approach and look for the facts, not faults. However, when the audit evidence determines that there is a nonconformity, then it is important that the nonconformity is documented and correctly. What is a nonconformity?

According to the definition in ISO 9000 a nonconformity is “non-fulfillment of a requirement”. There are three parts to a well-documented nonconformity:
  • the audit evidence to support auditor findings;
  • a record of the requirement against which the nonconformity is detected;
  • the statement of nonconformity.
While all of these need to be addressed, in actual practice, it is the audit evidence that is the first part to be identified and  documented. This is because a competent auditor will observe situations that they feel may be a potential nonconformity during an audit, even though it may not be 100 percent certain at that point in time.

If there is no audit evidence – there is no nonconformity. If there is evidence – it must be documented as a nonconformity.  Take caution of being, what is referred to as “soft auditing”. Another classification, e.g. “observations”, “opportunities for improvement”,  and “recommendations” can be useful, but only use appropriately.

The audit evidence should be documented and be sufficiently detailed, to enable the audited organization to find and confirm exactly what the auditor observed.
The next step the auditor will need to take is to identify and record the specific requirement that is not being met. Remember, a nonconformity is non-fulfillment of a requirement, so if the auditor cannot identify a requirement, then the auditor cannot raise a nonconformity.

The final (and most important) part of documenting a nonconformity is the writing of a statement of nonconformity.

The statement of nonconformity drives the cause analysis, correction and corrective action by the organization, so it needs to be precise.  The statement of nonconformity should be easily understood and interpretation properly, and be related to the system issue.

The following is a 4 step process we use and is very effective. It is also a topic of exercise during all our process based internal auditor training courses:
  1. Source of requirement (e.g. procedure ref., quality manual ref., clause of standard, position of person responsible who has made an oral statement of requirements, etc.)
  2. The specific requirement (e.g. relevant excerpt of procedure, quality manual, clause of standard, content of oral statement, etc.)
  3. Source of the evidence which conflicts with the requirement (e.g. identity of record(s), process identity, position of person responsible providing an oral statement of requirements, etc.)
  4. The actual evidence which conflicts with the requirements (e.g. relevant excerpt of record(s), examples off process, content of oral statement, etc.)

 

If all four of these parts of the nonconformity are well documented, the auditee, or any other knowledgeable person, will be always be able to read and understand the nonconformity.

In order to provide traceability, facilitate progress reviews, and evidence of completion of corrective actions and its effectiveness, it is essential that nonconformities are recorded and documented in a systematic manner.  Similar to internal root cause analysis methods also used.

Interested in more information on this process?

Seeking improved performance on your company internal audit system and nonconformity effectiveness? Register for our Process Based Internal Auditor training – onsite or classroom. Contact us, we are here to support your future management system transition training and business improvement needs.

 

Process Nonconformity Review

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In reviewing the response of a process to a nonconformity, the auditor should confirm that documented information and objective evidence for all three parts (correction, analysis of the cause, and corrective action) are provided by the organization, and are appropriate, before accepting the response. Important elements to verify in the review of process nonconformity include: 

  • statements of actions; are they clear and concise?
  • descriptions of actions; are they thorough and do they accurately reference specific documents, procedures etc., as appropriate?
  • the use of the past tense (was, has or have been, were), as an indicator that the actions taken have been completed.
  • the date of completion of the corrective actions; past dates should be found that indicate that the actions have been taken (dates indicating future action are not good practice).
  • evidence supporting the claim that a corrective action has been fully and effectively implemented and that the corrective action has been performed in the way that it was described. This is the most overlooked and weakest link of many nonconformance issues. 

Additionally, the auditor should verify that the organization has ensured that the corrective action taken does not itself create further problems relating to product or service quality, or to implementation of the QMS. Effective corrective action should prevent the recurrence of the nonconformity, by eliminating the root cause.

Analysis of the causes of detected nonconformities may identify potential nonconformities on a wider scale in other areas of the organization and provide input for planning based on risk based thinking. Another reason why communication of nonconformities should be shared throughout the organization – think management review.

Closing nonconformities:  As nonconformities tend to be individual in their nature, a variety of methods or activities may be used to demonstrate the effectiveness of actions taken. For example, some will require direct examination on site (which may require the need for additional site visits), while others may be closed-off remotely (by review of submitted documentary evidence).

 

Before deciding to agree to close a nonconformity, an auditor should review what the organization did in respect of containment, correction, cause analysis and corrective action results. The auditor needs to ensure that there is objective evidence (including supporting documentation) to demonstrate that the described corrective action has been fully implemented and is effective in preventing the nonconformity from re-occurring. Only once the situation is satisfactory, should the nonconformity be closed, and shared within the organization.

 

Top Predictions for Global Manufacturing
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By 2020, 60% of manufacturers will rely on digital platforms which will support as much as 30% of their overall revenue.

 
Industry Week recently published  report, “IDC FutureScape: Worldwide Manufacturing Predictions 2018,”  surveying the global manufacturing landscape.  When creating its predictions the firm examined ecosystems and experiences, greater intelligence in operational assets and processes, data capitalization, the convergence of information technology (IT) and operations.

Technologies that will have the greatest impact include cloud, mobile, big data and analytics, and internet of things (IoT). Manufacturers also have high expectations for the business value of technologies that are in earlier stages of adoption, such as robotics, cognitive computing/artificial intelligence (AI), 3D printing, augmented reality/virtual reality (AR/VR), and even blockchain.

Over the next few years, IDC identified some of the most notable changes in the industry:
  • Redefining how businesses design (or define), deliver and monetize products and services
  • Developing new contextualized and customized experiences for customers, employees and partners
  • Increasing coordination and collaboration between IT and line-of-business organizations, as well as among ecosystem participants
  • Changing the nature of work and how it’s accomplished with people, process, and technology coming together.
While the predictions offered largely focus on the near- to midterm (2018-2021), the impact of many of these will be felt for years to come.  
 
For more information on IDC’s worldwide manufacturing 2018 predictions and beyond you can read the full report located here.

 

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In the News
Sustainability in the Automotive Supply Chain

Updated document provides guidance to automotive supplier partners concerning the latest industry expectations in sustainability.

The Automotive Industry Action Group (AIAG) and Drive Sustainability today announced an updated version of the “Automotive Industry Guiding Principles to Enhance Sustainability Performance in the Supply Chain.” This collaboration between AIAG, Drive Sustainability and key automotive organizations provides guidance to our valued supplier partners concerning the latest industry expectations. Additionally, a supplementary reference document was created to provide further explanation and examples for the updated principles.

Free online courses and assessments along with additional options for AIAG members can be accessed. Click here  to read more information and to access the document.

 

ISO 45001 Occupational Health and Safety Standard  

Over 7,600 people die each day from work-related accidents or diseases – that’s over 2.78 million every year.

The burden of occupational injuries and diseases is significant, both for employers and the wider economy, resulting in losses from early retirements, staff absence and rising insurance premiums.

To combat the problem, ISO is developing a new standard, ISO 45001, Occupational health and safety management systems – Requirements, that will help organizations reduce this burden by providing a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world.

The standard has been developed by a committee of occupational health and safety experts, and will follow other generic management system approaches such as ISO 14001 and ISO 9001.  It is scheduled to be released in March 2018.

 

Training Courses
 
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.
 

Many of us are want to increase our productivity within our careers. Can you be more productive? Why aren’t you being more productive?

A recent study was conducted with interesting results of (1) Know your best working hours, (2) Visualize your goals and expected outcomes, (3) Set out your daily goals, (4) Choose a playlist of music favorites, (5) Use nature to improve your focus, and (6) Choose snacks that improve your brain focus.
Here’s to a Successful Productivity Year!

 

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