Posts Tagged ‘procedures’

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.

Document control – it can be easier than some may think!

Monday, March 29th, 2010

Recently, I was perusing through a quality discussion forum and the question was asked “Is it ever a good idea to organize and name your company’s files, documents, procedures, work instructions, and other items according to the numbering system of ISO/TS requirements?”

I am always horrified when a company starts constructing a quality system based on a standard rather than their own internal processes. Standards such as ISO 9001 or ISO/TS 16949 should be used as a guide for the construction of the quality system and not the reason for its existence. These types of “let’s satisfy ISO first” quality systems have a tendency to become thought of as documentation for “that annoying ISO stuff!”. This can eventually lead to documents being ignored, or worse, rewritten and uncontrolled in order to be thought of as more relevant to their use.

There is no prescriptive method for numbering or naming your quality system documentation. Usually, simple revision date codes or numbers can be used to provide a level of control needed to meet requirements.

Make your documentation easy to use by somehow identifying it with the process they are associated with to provide a more relevant and effective understanding of their use.

For more tips on document control, contact G3 Solutions today!

Writing a corrective action when “It wasn’t our fault!”

Friday, March 26th, 2010

When dealing with quality system standards such as ISO 9001, it is important to remember the emphasis put on continual improvement.

A recent event at a client location involved a customer complaint that turned out to be a supplier issue. When encouraged to write an internal corrective action, someone within the organization made the remark “Why should we write a corrective action if it wasn’t our fault? It was a supplier issue!”

At first thought, it sounds like a valid point. The whole situation was caused by the supplier. The organization did everything correctly according to their procedures. They also have a robust supplier management program that, as most felt, would provide a solid system to notify the supplier and request a root cause determination as to how the incident can be avoided in the future.

So why a corrective action? First, every incident involving a customer complaint truly is a golden opportunity to make sure it won’t repeat – no matter who is at fault. If it can happen once, it can happen again. And although people within the organization know that this time it isn’t the company’s fault, there is a high probability that the customer doesn’t care. All the customer knows is that they used a company to supply a product or service and something went wrong. The customer is also probably wondering “If this supplier is used again, what other headaches and heartburn will we encounter?” This can and probably will affect the customer perception of the organization (reference ISO 9001 clause 8.2.1 – Customer Satisfaction).

Secondly, we can’t forget Note 3 in ISO 9001 clause 4.1 – General Requirements that states “Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements.” Sure, the supplier got it wrong, but we are still responsible for the product or service we promised to the customer.

Finally, the fact that the organization followed all of their procedures is good, but how do they know that the procedures are right? Have changes in the organization occurred since the procedures were written and reviewed? And if the answer is yes, do our procedures allow for the flexibility of dealing with those changes? There probably is much to examine, explore and revise if changes in operations have been made.

Again, continual improvement should always be the emphasis when the customer isn’t happy. In the end, taking this approach can be the difference between happy or irate customers – not to mention repeat or lost revenue.

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 Implementation – Get People Involved!!

Friday, February 13th, 2009

The proper implementation of any quality management system should invole all employees in some manner, regardless of the standard. Many times it is common to see procedures and work instructions developed by personnel who do not (or have never) been part of that function or process. This can be one of the biggest mistakes a company can make in implementing a quality system.

One of the key principles that ISO 9001 and many other standards were based on is the involvement of people. People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s improvement.

The resulting output of employee involvent can provide numerous benefits, such as:

  • Motivated, committed and involved people within the organization.
  • Innovation and creativity in furthering the organization’s objectives.
  • People being accountable for their own performance.
  • People eager to participate in and contribute to continual improvement.

    Applying the principle of involvement of people typically leads to employees:

  • understanding the importance of their contribution and role in the organization.
  • identifying constraints to their performance.
  • accepting ownership of problems and their responsibility for solving them.
  • evaluating their performance against their personal goals and objectives.
  • actively seeking opportunities to enhance their competence, knowledge and experience.
  • freely sharing knowledge and experience.
  • openly discussing problems and issues.

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  • Visit our wesite at www.g3iso.com today!