Posts Tagged ‘processes’

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.

Next in our top ten countdown of quality system saboteurs – poor document control!

Sunday, April 18th, 2010

Not getting maximum benefit from your quality system? Poor document control always adds to inefficiency!

Reason #6 – Document control is not enforced!

Making sure everyone is working off of the same page (often quite literally) is the primary goal of the ISO 9001 clause 4.2.3 – Control of Documents. We hear from many quality managers and management representatives that this rather simple requirement, which seems on the surface to be easy to handle, can be a real bear to nail down. It is hard to imagine that this would be a difficult task, with most companies relying on electronic documentation. So what gets in the way of making complete and effective document control a given?

It generally starts with most companies not knowing just what to control. Sometimes it is assumed that the only documents needing control are those that make up the quality system. This narrow (and incorrect) interpretation of the requirement can lead to document chaos. Most companies have multitudes of documents that affect not only information getting to the customer, but also between departments, areas, and processes. Documentation that is not providing the most current info can wreak havoc with production schedules, customer communication and overall product/service quality.

Some areas/departments that are more isolated from traditional design and production processes (such as Accounting, IT, and off-site Sales personnel) may develop a whole subset of documents that might fly under the document control radar. There may be the thinking that certain documents are not important to control since the individual department is the only group using them for intra-departmental correspondence.

If there is confusion with knowing just what to control, let this be your guide: if any document or form provides direction, status, guidance or is kept as some sort of record, it should be controlled! Why risk the chance that someone might make a costly mistake with obsolete info? This is obvious when it comes to such items as specifications, drawings, assembly instructions and the like. But remember, document control can even include the most basic of communication tools such as fax cover sheets, inter-company memos, or business cards. Even the seemingly smallest overlooked items on documents like incorrect phone extensions, old email addresses, revised building or suite numbers, etc., can cause confusion with a fellow employee or boss, not to mention the customer!

For more info on how you can get a handle on document control, ask the experts at G3 Solutions today!

Does this scenario sound familiar? If so, G3 Solutions can help!

Saturday, April 10th, 2010

Top ten reasons why some quality systems are ineffective -

Reason #8 – The quality system is handled by one person

At G3 Solutions, we often receive calls from companies that are in need of expertise to help with quality system issues shortly before a third-party audit. This is often due to a lack of resources and downsizing from the recent economic nightmare of the past year.

Unfortunately, those employees that fell under the umbrella of “quality” were some of the first to be downsized. Since these employees were in charge of such key systems as internal audits, corrective actions and analysis of quality data, the maintenance of these systems would continually get put off until the last possible minute, if they were done at all. This is not the way a well implemented quality system should work.

Generally, the reason for this type of system meltdown is that most, if not all key functions of the system were handled by one employee whose primary purpose in the company was to be “the ISO person”. They were responsible for making sure all of that ISO 9001 “stuff” got done, and now they are not around – and no one has a clue as to what needs to be maintained.

A well implemented system will almost run by itself, with just minimal oversight by the selected management representative. Key systems should be shared and divided by top management; not handled solely by the quality manager or ISO coordinator. Not only will this shared strategy help maintain key processes, but will also encourage and promote employees to work with and improve the quality system.

For further information on how we can help, contact G3 Solutions today!

Top ten reasons for an ineffective QMS!

Monday, April 5th, 2010

Reason #9 – Negligence in training employees to properly use the system!

Competence, training and awareness for employees is more than just a simple ISO 9001 requirement – it is a major factor in the difference of having a system that will work as either a) a tool for continual improvement, or b) a worthless set of documents that are not followed.

Many third party auditors will often look at the training records of the oldest and newest employees as well as directly asking them questions as to how they access and utilize their system. It can be a very good barometer of how well the entire quality management system (QMS) is working.

The reason behind this type of audit sampling is that many company “veterans” will often provide candid feedback on portions of the system that are not operating as documented. In some instances, these employees will even reveal ways that the current system is bypassed for efficiency, especially when improvements to processes are not made. With new employees, training effectiveness is easy to assess based on whether the QMS information and training given to them is memorable, and then asking if they can actually demonstrate use of the system.

Training on the quality system for new hires and ongoing training for veteran employees should be a priority for any company looking to get the most out of their QMS.

For some creative ideas on how to get your employees trained as QMS experts, contact the ISO experts at G3 Solutions today!

Identifying Environmental Aspects for ISO 14001

Tuesday, April 28th, 2009

During ISO 14001 implementation, the most important exercise a company will go through is identifying all possible environmental aspects. Without a proper and thorough examination of all processes, functions and grounds of a facility, the rest of the environmental management system (EMS) is an exercise in meaningless documentation.

Once all aspects are identified, a determination must be made as to what aspects are significant and if they are within the organizations ability to control. This is best conducted through some type of risk analysis format such as a failure mode and effects analysis (FMEA) type review of the aspects.

If the process of identifying all environmental aspects of your company’s activities is becoming a daunting task due to limited or stretched resources, contact the experts at G3 Solutions today!

ISO 9001 – It is time to put the “document nightmare” perception away! (Part 2 of 3)

Thursday, April 23rd, 2009

As we stated in Part 1, documentation for ISO 9001 does not need to be complex. With that being said, the next question that we are usually asked is “How do I show conformance to the standard when I don’t have a document for everything?”

In the ISO 9001 guidance document “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008”, it states the following:

“To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines ‘objective evidence’ as ‘data supporting the existence or variety of something’ and notes that ‘objective evidence may be obtained through observation, measurement, test, or other means.”

This suggestion provides an amazing amount of flexibility in showing conformance to the standard. If you need assistance with your ISO 9001 system, contact the ISO 9001 experts at G3 Solutions today!

Implementation of ISO 9001 and other standards – planning is key!

Wednesday, January 28th, 2009

As with any project, having a solid plan to follow will usually be an accurate indicator of whether the project will flounder or finish on time. Implementation of quality standards such as ISO 9001, ISO/TS 16949, AS9100, ISO 13485 and others are no exception.

When beginning implementation of an ISO standard, key questions must be asked. Here are a few for starters:
• Will the project involve one site or will it include multiple facilities?
• What types of activities will be covered under the scope?
• Do we need to make exclusions for such items as design, servicing and special process verification? Will exclusions be allowed, depending on the standard?
• Will the implementation team need formal training?
• How well are key processes identified?
• What company measurables are in place? Are they adequate? Can they be linked to continual improvement?
• Do we need some outside expertise?

This is only the beginning. Once these questions are answered, projects and assignments can be distributed to the proper personnel. It is important that key project milestones and activities have realistic due dates and that those dates are monitored.

Most importantly, the involvement of as many employees as possible in the implementation/documentation phase is critical. Employees that are involved and are solicited for input during the project generally take more ownership of policies and procedures. This helps to create a “quality culture” throughout the organization.