Documenting Process Nonconformity
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Our newsletters provide information on business management systems and process improvement methods. These systems 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. Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

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Documenting Process Nonconformity

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, or any other global management system.  So, the emphasis of a management system audit should be on verifying conformity and effectiveness, not just on documenting nonconformities.

 

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, instead of being softened with another classification (e.g. “observations”, “opportunities for improvement”, “recommendations”, etc.).

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.

 

Note: ISO 9001 contains clauses that can include more than one requirement. It is important that the auditor identifies and records the specific requirement relating to the nonconformity clearly, for example, by writing-out the exact text of the requirement from the standard that is applicable to the audit evidence. This may also apply to other sources of requirements. 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 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? Contact us, we are here to support all your future transition training and improvement needs.

 

 

Nonconformity Review and Closure
 

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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 process 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.
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 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.

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.

 

SES August 2016 Events
   

ISO 9001:2015 What’s it all About?

Walter Tighe, President/Owner of Sustaining Edge Solutions, Inc. will be presenting valuable information on the ISO 9001:2015 Standard at the American Society for Quality (ASQ) Phoenix Chapter Meeting on Thursday, August 11, 2016. The meeting will be held at the Edward Jones Training Facility 8333 S. River Parkway Tempe, Arizona starting at 6:00 p.m.

This event is free and open to the general public.  For more information, and on becoming a member of the American Society for Quality, visit the chapter website.  See you there!

 

ISO 9001:2015 Transition Training 
 
Here’s your opportunity to understand the new ISO 9001:2015 standard requirements, application and impact on your existing quality management system.  The ISO 9001:2015 standard is now released in the  High Level Structure with stronger links to organizational strategies and goals.  The new Standard also emphasizes risk-based thinking to planning and implementing quality management system processes.

SES is delivering an ISO 9001:2015 Transition course on Monday, August 15th, 2016 at the Hyatt Place 3535 W. Chandler Boulevard Chandler, AZ. Students receive a comprehensive workbook, and a certificate of training completion.  Lunch is provided and seats are limited.

Click on Link  for course description, registration and payment method.  Seats are limited.  Any questions, please contact us.

 

Viewing Quality as a Strategic Asset
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While more organizations in 2016 view quality as a strategic asset and competitive differentiator when compared with 2013, the majority of organizations don’t know or don’t measure the financial impact of quality, according to a new report by ASQ – the leading global authority on quality in all fields, organizations and industries.
According to the Global State of Quality 2 Research: Discoveries 2016, report 36 percent of survey respondents said their organization views quality as a strategic asset and competitive differentiator, up from 22 percent in the inaugural Global State of Quality Research of 2013.

The increase in organizations viewing quality as a competitive differentiator and strategic asset is a positive shift from organizations that simply view quality as a compliance, or check-the-box activity. In 2016, 14 percent of survey participants said their organizations view quality as simply a compliance activity, compared with 22 percent in 2013.

ASQ and its research partner, APQC, analyzed responses from nearly 1,700 participants worldwide, identifying world-class organizations that possessed the strongest end-to-end quality practices. The research also offers 10 steps organizations can take to advance toward world-class quality.

 

According to the research:

  • One hundred percent of world-class organizations increased investment in quality over the last three years, compared with 54 percent of nonworld-class organizations.
  • Ninety-three percent of world-class organizations’ most visible metrics center on performance against customer needs, compared with 34 percent of nonworld-class organizations.
  • World-class organizations have half the rate of quality setbacks, like recalls, product defects etc., than nonworld-class organizations.
  • Ninety-six percent see quality as a strategic asset and competitive differentiator – triple the nonworld-class rate.
As more organizations transition their quality function from a compliance activity to a strategic asset and competitive differentiator (ISO 9001:2015?), more companies rely on quality departments to drive profitability through innovation, new product development and a focus on customer experience.
But while organizations use quality to drive innovation, new product development, customer experience and more, few measure the financial impact of quality. According to the report, 60 percent of all respondents say they don’t know or don’t measure the financial impact of quality.

60%! The report suggests the lack of measuring the financial impact of quality could be a result of a common method. It also suggests an organization’s culture may discourage tracking remediation costs because it might call unwanted attention to recalls, product defects and more.

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In the News
 Arizona Tops New Ranking for Aerospace Manufacturing

 

Arizona is home to more than 1,200 aerospace and defense companies, according to the Arizona Commerce Authority, and the industry’s growth in the state has put it in the top ranking for aerospace manufacturing. PricewaterhouseCoopers released a ranking of the top places for aerospace manufacturing, and Arizona came in at No. 1, beating out Florida, Utah and Georgia, among others. According to the study, Arizona ranked high thanks to property and unemployment taxes, as well as operating costs and employment.

 

Arizona’s aerospace and defense total exports rose by almost 22 percent from 2011 to 2014, reaching a $3.47 billion total, primarily due to a near $400 million increase in aircraft, engines and parts exports, according to a 2015 study by the International Trade Administration.

Honeywell, Boeing and Raytheon are some of Arizona’s biggest hitters in the aerospace industry. PwC’s study highlights Bombardier Aerospace and its almost 14 percent increased workforce at the Tucson International Airport.

 

ISO 50001 Energy Management System Update 

Following the ISO Technical Committee, ISO/TC 242, now TC 301’s June meeting in Stockholm to discuss the revision of ISO 50001, currently available information indicates that ISO 50001:2019 is likely to be published in January 2019.

ISO 50001, Energy Management Systems – Requirements with guidance for use, was established to help organizations develop and establish systems to improve their energy performance including energy efficiency improvements, and energy consumption reductions and cost – in turn leading to reductions in greenhouse gas emissions.

ISO 50001 has already proven to be a popular standard, with more than 7,000 organizations globally certified to the standard by the end of 2014.

 

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.
 
Global State of Quality Report 2016  
Investment in Quality for the last 3 years
$ World Class Organizations: 100%
$  Non-World Class:  10% Deceased
   28% Stayed the Same
   54% Increased
Customers are the key drivers of our quality program:
                                Somewhat Agree 26%
                                Highly Agree: 60%

Best Regards,

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

Copyright © 2014. All Rights Reserved.

 

 

 

This entry was posted on Monday, August 1st, 2016 at 7:10 am and is filed under Newsletters. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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