Certification Body Service

 

This Month

 Events
Register Now! Lunch and Learn – Achieving Breakthrough Performance
This Tuesday November 5, 2019 Tempe, AZ. 
Details and Promo Code below.     
 
ISO 9001:2015 Internal Auditor Training November 13-14, 2019-Tucson
Contact us for registration and special pricing   
      

 

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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, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, and ISO 14001 Environmental Management Standards. 
 
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? Please let us know.

Certification Body Process Service
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All organizations that are registered to management systems standards such as ISO 9001 or AS9100 have a Certification Body (CB), also known as a Registrar.  The CB is responsible for certifying the company and conducts onsite audits on a semi annual or annual basis. Some of these CB auditors do travel from other states to conduct surveillance or recertification audits.  Client contractual agreements made (usually covering a three-year period) often state that  the auditor will use the most “cost effective” methods for travel.

If you’re a quality systems professional with at least twenty plus years of experience, you remember the past stories about auditors receiving that special treatment, high dollar dinners, special gifts and fancy hotels. I can picture many of you reminiscing right now, remembering those days of gratuitous behavior.  We certainly do.

Many organizations are also aware that the majority of these auditors are working for the CB’s as a contract auditor- not a full time employee. The majority of CB’s do ensure that their auditors follow specific rules about spending, and they do a good job reviewing receipts and ensuring they comply with specific rules.

 

However, every so often we still hear about that one bad apple. A client of ours recently had an out-of-state auditor from a global CB arrive in a high end performance car (average daily rate ($150- $200.00). The auditor was from the East Coast (no prejudice, we were born there) flying to the West. The company he was auditing was a number of miles away from a major city or hotel service. He inquired prior to arriving where the “nicest hotel” could be found. Unknowing to our client, the auditor also stayed at a high price hotel and we can only imagine what the food bill amounted to. Remember, all auditor travel costs are charged to and paid for by the client.

 

We do know that this occurrence nowadays is a rarity, but be aware that it’s totally acceptable to question any charges that you feel go beyond the conventional.

 

 

Under the auspice of continuous improvement, we have queried our clients over the years about their CB experiences with regards to expectations and services provided. Problems range from administrative – leaving messages with no return call – to prescriptive auditors – issuing non-conformances for items not required or even identified within the Standard. For example, management review requires signatures of attendees. Examples of further comments received include:
  • Customer service person does not know how to reach the auditor when client calls.
  • Customer service person is not trained in the basic understanding of the subject standard inquiry or application process.
  • Client e-mails documentation for review to auditor with Gmail account and the e-mail is returned because file is too large.
  • Client receives advanced audit schedule and auditor does not follow-up with a call to confirm audit arrival, or if any questions; one week or even the day prior to the audit.

     

According to Quality Digest Magazine,the most important certification body customer satisfaction items are:
  1. Was the audit fair?
  2. Was the CB very responsive?
  3. Was the auditor professional?
  4. Was the auditor technically qualified?
  5. Was the auditor objective?
  6. Did the auditor understand how to apply ISO Standard to your business?
  7. Was the auditor a good communicator?
  8. Was the auditor realistic about applying ISO Standard to your company?
  9. Did the CB return calls in a timely manner?
According to the Quality Digest Magazine report, most companies are satisfied with their certification body.  However, taking the time and making the effort to select a service provider, and interviewing the auditor is worth the investment as you will reap the benefits for years to come.

 

Product and Process Audits
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Imagine you’re a supplier seeing a large spike in returns over a component with a high failure rate. After a complete investigation, you discover a production process which hasn’t been measuring an internal component to the proper diameter. Having already shipped numerous items, you realize the problem is far from over, putting your most important contract at serious business risk.

How did this happen? Your final inspector is performing a clear system of product audits and inspection. The hard fact is product inspections don’t always catch process issues responsible for defects. If your quality checks in manufacturing are centered on product audits, your process audits are even more important to quality conformance. Let’s look at the difference between product and process audits.

 

Non-conformances undetected early in the process are often passed through the supply chain causing major disruptions or could even be undetected until an incident occurs. There are critical control points which need to be monitored to prevent these issues.

Product audits usually take place after manufacturing is complete, but before the product reaches the customer. If a product doesn’t meet requirements or specifications, an auditor, or an inspector documents the findings and logs a non-conformance. While each company has its own methods for addressing non-conformances, the process typically includes:
  • Identifying the problem
  • Containing the non-conformance
  • Reworking or repairing the products, if possible
  • Disposing of nonconforming products if you can’t rework or repair them
  • Determining the disposition necessary for preventing recurrence of the nonconformance.

 

Product audits can help improve quality and customer satisfaction. However, finding defects after the product is built contributes directly to increased labor, material, and cycle time costs of inefficiency.

Process Audits focus on how your team plans, builds, packages and delivers your products. This approach provides a more comprehensive view of the value stream that product audits don’t, which only sample the finished output. Process audits look at details of the manufacturing process such as:

  • Planning steps
  • Fabrication methods
  • Safety measures
  • Temperature & environment settings
  • Measurement and documented methods criteria
  • Calibration of gauges
Even experienced team members can deviate from standard work instructions over time, leading to variation and quality issues. An effective manufacturing process audit system that ensures the highest level of quality requires both effective product and process audits.

Documented System Design
A critical question that many organizations face when starting a documented operational management system or improving a current one is “How much documentation is required?”

We find today in many cases that lessons learned from past year’s experiences is driving a “less is more” when it comes to management systems documentation. If we cannot rely on this standard telling us where and how much documentation to write, what can we base our decision on?

 
Do we base it on:
  • Documentation given to us to copy from another organization?
  • A canned template software program “ISO kits” found on the Internet?
  • A 2 page Quality Manual (or is that 4 pages) external firms are presenting to you?
The answer is in the risk associated with needing to control your business processes. What is the risk of a certain system or process not being controlled? Many factors come into play: personnel experience, competencies, turnover, task complexity, customer and regulatory requirements are just some to be considered.

No two management systems are quite the same. Documentation will look different; exclusions are taken for requirements that don’t apply. The number and diversity of procedures, work instructions, and forms, will always vary.

 
A standard’s structure should be a guide for the kinds of documents the organization should consider including within their system. We have seen too many cases where the requirements themselves are only used for guidance (example: verbatim standard language for policies) rather than a sequenced and integrated documentation focus for improving company competitiveness and profitability.
 
Use a risk management process applicable to your internal and external requirements, products and processes when developing documentation and the amount required. Remember, a healthy appreciation of the value of process control documentation is the difference between a certification hanging on the wall, or a sustained organization that always satisfies its customer needs.

 

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In the News
Register Now! 

 
Arizona Technology Council Lunch and Learn –

 

At this informative Lunch & Learn, attendees will learn how to develop a framework for evaluating and establishing breakthrough improvement within their organizations.
  • Understand the critical operational challenges affecting your organizations future.
  • Identify and take action against common business process gaps affecting customer relationships.
  • Learn the truth about the lack of industry employee engagement, the negative cost to business effectiveness and actionable questions.
  • Recognize best practices and lessons learned for achieving operational excellence.
Date: Tuesday November 5, 2019

Time: 11:30AM – 1:00PM

Location: BENCHMARK HEADQUARTERS

56 South Rockford Drive Tempe, Arizona

Click Here for more Event information and Registration. Use PROMO CODE “SUCCESSfor free registration. Lunch is included.

World Quality Month is Here!

 
November is World Quality Month!  It is a worldwide celebration of quality. It’s a time to showcase the advancement and valuable contributions quality professionals make in businesses, communities, and institutions. This month allows all to shine a light on the industry and the individuals striving to provide excellence through quality.
Visit the World Quality Month Website for current and ongoing information to be posted through November.

 

ISO 9001:2015 Process Based Internal Auditor Training  November 13-14, 2019 Tucson, AZ

Location: Azbil-BioVigilant Division 2005 W. Ruthruff Road. Contact us for registration and special pricing!
 

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.
 

At this time of year it is natural to reflect on your annual performance and set personal and business goals for the upcoming year.

The question is what kind of results do you want to create for yourself and your business? Do you have customers coming back for more of your product or service? Do you have a set of ideal customers you want to cultivate? Are your business processes in control and capable of producing what you and your customers require on a continuous basis?

The demands of today’s business environment have caused many of us to shift our approach from thinking as a professional to acting as an entrepreneur. Avoiding past mistakes and taking the time to plan your next moves can make the difference between an exceptional year, and a mediocre year for you and your organization.

Let us know if we can assistance you with achieving your Year 2020 and beyond Business Goals!

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

 

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