Archive for the ‘ISO Internal Auditing’ Category

Too much time to document corrective actions? Consider the long term benefit!

Sunday, May 23rd, 2010

Reason # 4 in our Top Ten Countdown of quality system mistakes-

#4 – Corrective actions aren’t documented!

When conducting internal audits, we often see third party registrar reports that contain a nonconformance finding for not documenting corrective actions as stated in the company’s written procedures. The usual response is that there just isn’t enough time to document issues when they can be solved (or perceived as solved) within a short period of time. Although this may seem true on the surface, after a little investigative auditing, we often find that some of those issues that were “fixed” on the fly are coming back repeatedly either in the same area or in other areas of the business.

Although it is easy to rationalize the behavior of making simple quick process corrections without going through the formal documentation route, the end result is almost always the same. Since the issue was not documented and many other areas of the company were not aware of the problem, not to mention the solution (which may or may not be long term), the problem keeps raising its ugly head.

There is tremendous value when a corrective action is properly documented, true root cause is determined and long term solutions are communicated to all functions of the organization. These “extra steps” that can, on the surface, seem troublesome and time consuming but can actually save both time and money by reducing or eliminating repeat nonconforming issues. Please keep in mind we are not suggesting the documentation of every little operational issue that requires simple adjustment during the course of doing business. We are talking about those issues that can affect the customer and/or have an effect on internal processes.

For information on how to effectively document corrective actions, contact the experts at G3 Solutions.

New (or maybe rumored) Corrective and Preventive Action requirements! Make sure your system is up to speed!

Friday, May 8th, 2009

In order to accommodate the rumored additional changes to ISO 9001:2008, you will need to incorporate the following form into your organizations Corrective and Preventive Action system. It is also rumored that these requirements will affect additional standards such as ISO/TS 16949, ISO 14001, AS9100, ISO 13485, ISO 22000 and various other standards.

Free download: iso-mil-hf-car-par

The downloadable form was developed by members of the military to facilitate the documentation of key personal issues into a corrective and preventive action format. If you have any questions or require any help in the application or requirements of this form, please contact G3 Solutions. We will do our best to aid in the development of your quality management system and sense of humor.

During an internal audit, get honest feedback from employees

Tuesday, April 21st, 2009

The internal audit process is an extremely important part of any ISO-based quality or environmental management system. It can be the “make it or break it” process that will determine just how effective your system will be based on the proper input from employees. Unfortunately, as part of the natural human tendency to avoid anyone with the title of “auditor”, people will often treat the internal auditor as someone to avoid in fear of being singled out or used as an example.

“I have a theory that the truth is never told during the nine-to-five hours.” – Hunter S. Thompson

This is why companies must give some good thought as to the audit team they will select. Not only must the auditor be a good communicator and data analyzer, the auditor must be able to get people to want to talk about what they do and how they do it.

Sure, there is plenty of guidance as to what makes a good auditor in ISO 19011. In fact, some of the terms used to describe auditor qualities in 19011 sound like a scouts honor pledge – honest, trustworthy, loyal, brave, etc… (Well, OK, maybe not those last three!) Certain stated qualities are important, but there are some things that just go by feel – is the person approachable, enthusiastic, and positive? Can they express themselves well and “message” people who are overly sensitive to anything that may seem like criticism, like a minor nonconformance?

If it is becoming a real chore getting the right people in your organization to perform internal audits, consider the option of an expert and true auditing professional conducting your audits – it may be the smart choice. Contact G3 Solutions today to find out just how affordable and value-added contracting/outsourcing your internal audits can be!

Records – are you keeping all that you should?

Thursday, April 16th, 2009

Many companies registered to ISO 9001:2000 are now reviewing their quality management system (QMS) along with associated forms and documents to make sure that there is a smooth, trouble free certificate upgrade to ISO 9001:2008. This is a great opportunity to make sure that all records required to maintain the business are kept in such a way to satisfy the ISO 9001 clause 4.2.4, which states “Records shall remain legible, readily identifiable and retrievable.”

Companies should consider every record needed for the business, not just the ones listed for ISO 9001. Having all important records fall under the scope of the control of records procedure helps to provide real value in the QMS. If you have a system that is based on ISO 9001 but includes other requirements (e.g. – ISO/TS 16949, AS9100, ISO 13485, etc.), the list of records for 9001 is just the beginning of what needs to be maintained.

For a complete list of ISO 9001 required records, you can download the following document:
iso-9001-2008-records

If you need additional help with ISO requirements, visit g3iso.com today!

If only all business travel was this much fun!

Saturday, April 11th, 2009

Normally we use this blog for serious (or at least semi-serious) ISO info, but we just had to pass this along. The attached video has absolutely nothing to do with ISO 9001, ISO/TS 16949, AS9100, ISO 13485, ISO 14001 or any other ISO standard – we promise! If you travel a lot for business, you will definitely appreciate the clip.

Have some fun – click on the following link and watch: rapping_flight_attendant

When it comes to training, don’t forget the follow up!

Thursday, April 9th, 2009

Most companies do a good job of providing proper employee training to ensure a qualified and competent workforce. Clause 6.2.2c in ISO 9001 clearly states that any training or other actions taken by top management to achieve competence must be evaluated for effectiveness. This also holds true for many standards such as ISO/TS 16949, AS9100, ISO 14001, ISO 13485 and others.

A common issue found during internal and external audits is the lack of evidence to demonstrate that effectiveness is evaluated. Keep in mind the standard does not prescribe how this is to be done, so there is tremendous flexibility in how this task can be completed.

Always consider that every ISO requirement does not need a new procedure, work instruction or form! Simple changes to existing process documents can, in most cases, do the job just fine. Make sure the method chosen provides a gage that is useful to the company in evaluating resource needs. Remember, the goal for any quality system is to provide value to an organization – not just fulfill standard requirements.

For more information, visit g3iso.com today!

When conducting internal audits, planning is key

Tuesday, March 31st, 2009

As consultants and trainers, we are often asked about the internal audit process and the amount of time that should be given to internal auditors to complete their audit. Obviously, there are many factors that go into the calculation of time that should be spent performing an audit. Complexity of process, number of employees, number of facilities and document review all have a big factor in audit time management.

One area that should always be given a significant amount of audit time is document review. Too often, we see companies that provide to their audit team members pre-packaged materials such as audit checklists or a few standard questions that become both predictable and repetitive, and end up providing no real value to the process.

Internal auditors should be given plenty of time to review the appropriate standard, process flow diagrams, procedures, work instructions, key metrics/measureables and previous audit data to ensure that they have a thorough understanding of what should be happening before they conduct the audit. The end result will be an effective audit that can provide real benefits and continual improvement opportunities.

Visit g3iso.com for more tips on internal audits.

ISO/TS 16949 registered? Maintain those customer specific requirements!

Thursday, March 12th, 2009

If your organization is registered to ISO/TS 16949, make sure that you periodically update and maintain your data library with the latest and greatest customer specific requirements. These can be found at the following website:

http://www.iatfglobaloversight.org/

The site includes the latest and greatest automotive OEM Customer-Specific Requirements for:

  • Chrysler LLC
  • FIAT Group Automobiles SpA
  • Ford Motor Company
  • General Motors
  • IAOB Clarification – Customer Special Status Conditions

    You will also find information on ISO/TS 16949:2002 Sanctioned Interpretations and FAQs. Much of the information that can be found throughout the site is available in English, German, French and Italian.

  • For more information, visit our full website at www.g3iso.com today!

    Internal Audits – more than just a quality exercise!

    Tuesday, February 17th, 2009

    There is a requirement in most ISO 9001 based quality management standards to conduct an internal audit of the organization’s management system. The requirement is even a part of the environmental ISO 14001 standard. This should be viewed as more than just an exercise to “dot the i’s and cross the t’s”. An internal audit is a great opportunity to ensure the effectiveness of the system by providing employees with an avenue to spot issues and even suggest improvements.

    Some valuable secondary effects of a well-executed internal audit can include:

  • An opportunity to train or reinforce the workings of the system. Auditors should let the auditees know the findings that were uncovered during the audit and also provide the correct information on where to find answers to questions regarding the system.
  • Employee feedback on potential process improvement actions. Employees that perform many of the key process functions often have good ideas on increasing the efficiency and ease of the job.
  • A feeling of inclusion and teamwork in helping to make the company better. This can be the catalyst for change in an indifferent attitude toward company policies and procedures.

    If you’re not getting enough out of your internal audit process, contact G3 Solutions to find out how we can help!

  • Visit our full website at www.g3iso.com today!

    Need ISO help? Ask us here first!

    Wednesday, January 21st, 2009

    Stuck on some quality or environmental issue and don’t know what to do? Post it here and we’ll ask our team of experts what they think is the answer. Questions can be on anything related to a quality or environmental system, standard, concept, program, etc. – you get the idea. What the heck – its free! Go on and ask. Consultants love to hear themselves talk – or in this case, see themselves write. We’re even humble enough to admit you might have a better idea or solution than us! So go on and post it and let’s see what happens.

    Visit www.g3iso.com