Management Solutions Group • 2879 Hoag NE • Grand Rapids, MI 49525 •  Phone: (616) 365-9822

Internal Audits during a Pandemic

pandemic fakeThe events of this past year have created challenges for many organizations working to complete internal audits and maintain their management systems. With the large number of organizations that we work with, we have encountered some specific issues that affect most of them and some specific solutions to these challenges.

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Environmental Regulatory Change Notification?

EPA Regulation changeThe EPA has released the Hazardous Generator Improvement Rule, Federally Implemented starting May 30, 2017, and adopted by states thereafter (Typically July 1, 2018 or July 1, 2019 or later) and Michigan as of August 1, 2020. Note that this does not only apply to organization that are ISO 14001 Certified, but any organization with any wastes. The EPA estimates, based on regular inspections, that up-to 30% of all organizations are noncompliant with these rules. One of the goals of this revision was to make the rules more understandable.

This article is not intended to be a full review of the requirements, just some highlights of the changes that affect the large number service and manufacturing organizations. There is a lot of free information available on the web. If you have any specific questions just contact us and we will assist you or point you in the correct direction for details.

Some of the changes that affect a lot of our clients are:

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Challenges for Internal Auditors during COVID-19

internal audits during covid 192020 Challenges: What should I be focusing on with my Management Systems (Quality, Environmental, Safety, Laboratory, Information Security…)

  • What should I do to make sure my 3rd party audit goes well?
  • What should I do to help my company through these challenging times?

With the pandemic and staff working from home, the management systems (ISO 9001, ISO 14001, ISO 45001 etc.) follow through can be a challenge, as well as the internal audit and improvement processes.  Many organizations are working in smaller groups, performing more of the basic functions, and skipping some of the important documentation due to other important organizational needs. This does not leave us without opportunities to accomplish important tasks.  Here are a few suggestions that will not only create improvements and risk reduction, but will also continue to support a management system’s requirements:

  • Conduct internal audits focused on documentation and records. This can be done remotely and can also identify outdated language, redundant documentation that may not be consistent, and areas for improvement. These audits can be followed up with documentation and records process improvements. Future audits can always include increased production or manufacturing floor audits as a focus.
  • Focus the audit and risk identification processes on contingency plans. This can allow an organization to document lessons learned and improve the organizations processes and contingency plans going forward. It will likely be some time before things in most organizations really return to normal, so improvements in these areas can be valuable for an organization.
  • Management system staff and internal auditors can also assist departments and areas of the company organize and improve their processes in a changing environment. These staff are typically more trained and focused on this aspect of the work which can be of great value to many areas of an organization.
  • Some specific areas to watch:
    • IATF Temporary Change requirements
    • Automotive PPAP requirements for internal changes
    • IATF Shutdown and Startup requirements, where applicable
    • Scheduling processes where order quantities are changing
    • Changes to workflow and security requirements for staff working remotely
    • Supplier management and development – many of the above items would also apply to the organization’s suppliers, and to protect your organization, you may want to ensure you are reviewing suppliers to determine if they are proactively addressing these changes and associated risks

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How to Correct Common Transition Audit Nonconformances

Michigan Business Management Consulting Quality Management(IATF 16949 Surveillance audit, transition audit, upgrade audit)

We have been reviewing the data from many sources on the common nonconformances during transition audits for IATF 16949: 2016 as well as ISO 9001, ISO 14001, AS9100, ISO 13485 and now ISO 17025.

Some things stay the same

An analysis of the data identified many nonconformances that are consistent with audits conducted prior to the newly revised standards. These nonconformance are more common than those written to the new requirements for companies that spend more time addressing the new requirements explicitly in their management systems. Examples include:
  • A gage that is past due for calibration without any extension records
  • Control Plans and PFMEAs that do not match
  • Work instructions that are not being followed or out of date…

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IATF 16949: 2016 & ISO 9001: 2015 Quality Management Systems Upgrade

iso 16949 inspectionHere is some very good advice on migrating to the new 16949 standard.

When you are looking at upgrading your management systems to meet the new requirements, you really need a solid approach to the project ahead. One important piece of advice that we have learned from experience is that when resources are needed for a project like this, it is critical to obtain the resources at the beginning of the project. If you are able to muddle your way through the process and achieve registration to the new standard which the hopes of finding resources to make the necessary improvement to the management system after certification, you will likely be disappointed. Here are some additional suggestions to the approach to the project:

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Upcoming Changes to ISO 9001:2015

What are notable changes?

The new ISO 9001 standard aligns with high-level organizational structure, requiring all new ISO management system standards to be aligned on a high-level structure with a set of common requirements.

Additionally, there is a greater emphasis on risk-based thinking as a basis for the management system, more focus on achieving value for the company and its customers, increased flexibility regarding use of documentation, and a more approachable structure for service businesses.

Welcome Lisa Hemmer

lisa hemmerAs we grow and work with our clients with all of the revisions to the standards and the Management Systems, along with increased web based and onsite training, our internal workload has increased.  We were extremely fortunate that an associate we all worked with some time ago is able to join our team.  Lisa Hemmer has worked in the Sales, customer services and overall management in our industry for some time.  Lisa has worked for leading registration companies in the past and has a real knowledge of the registration, training and consulting industry. 

In addition to this, Lisa has recently worked as a quality manager managing an ISO 9001 certified quality management system.  This has also given her the insight and understanding of the efforts and struggles that many of our clients experience on a daily basis.  Lisa will be answering our phones every day, with a goal that we are more accessible to our clients, as well as assisting with our training and scheduling.  Lisa is also qualified and may assist clients with internal audits, corrective actions and other related work.  Just call 616-365-9822 if there is anything that Lisa can assist you with or questions you may have.

Take a look at all our team members.

The Employers Association Classes

TEA logoWe have partnered with The Employers' Association for our public classes. You can check our schedule at

Here is the upcoming Public Class Schedule:

March 20th ISO 9001:2015 Changes - 8:30am-12:00pm

                ISO 14001:2015 1:00-4:30 pm
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We review your requirements, then give you a menu of options to meet your budget and schedule.  MSG helps you determine:
  • Goals and objectives
  • Which certifications or standards are applicable
  • What individuals should be involved to tailor your training
  • A time schedule
  • Resources necessary to ensure a successful program launch

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