Archive for January, 2009

Meetings – friend or foe to the productive?

Wednesday, January 28th, 2009

It seems it never ends. You’re scheduled to go into a meeting to discuss the actions from the last meeting and plan for the next meeting. You look at your Outlook calendar or Blackberry and see that your theoretical 40 hour work week contains 50 hours of meetings. In between all of these meetings, you’re responsible to actually be productive in some accountable manner. How did things get this way? More importantly, you wonder – how can this cycle of chaos be stopped?

Here are 4 … no, wait, 5 … okay, 6 of the best solutions we’ve seen for curing “meeting madness”-

1) We’re here because…??? There better be a good reason for a meeting. ALWAYS have a specific agenda – no matter how small the meeting or how small the number of topics. Have one in print or electronic form and distribute to all participants. This will help to keep a focus on what is important and will help to avoid random topics.

2) Have participants do an impression of their favorite tree! Stand! If time is critical, or if people get too comfortable sitting down and tuning out, have everyone stand during the meeting. Make chairs off limits and keep people literally on their toes. You’ll be surprised how quickly and efficiently people will get to the point. Lengthy meetings will no longer be a problem.

3) Members only! Invite only those participants that will play a direct role in the agenda items. During the meeting, participants should state to the group the people they will communicate with regarding relevant topics/action items and when that will happen. Communication accountability is crucial! No accountability produces no results!!!

4) Share the spotlight! Make sure all participants provide input of some kind – either something to report (such as objectives or department measurables) or they should make a statement as to what their role will be in any action items that are discussed. Remember: No participation = no interest = no action. (We at G3 call this equation “The Gogoleski Theorem”)

5) Somebody write this stuff down! Create a SIMPLE system to document and track action items. Make sure it includes assignees and due dates. You can even make action items official corrective or preventive actions as part of your quality system. Anything less and key strategic ideas become nothing more than “thought bubbles” that eventually pop and become forgotten flashes of brilliance that your competitors will somehow document, implement and execute before you do! (And wow, is that painful!)

6) Don’t schedule another meeting for follow-up to the one you just had!!! Duh! This becomes the most effective exercise ever created for wasting time and reducing productivity. Make follow ups electronic (or paper – only if you really need to – save a tree) with cc’s to all participants of the original meeting. No accountability produces __ ______!!! (see # 3 for answer)

Now go forth and be productive!!!

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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.

ISO 13485 makes a reference to ISO 14971 for risk analysis – what is it?

Tuesday, January 27th, 2009

One requirement in the medical device standard ISO 13485 is for risk management to be conducted throughout product realization (reference the last paragraph in ISO 13485 section 7.1 and also Note 3 for that section). ISO 14971 is a guidance document that gives direction for performing risk analysis. The document makes reference to various quality tools such as Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA) and Failure Modes Effects, and Criticality Analysis (FMECA). These tools are often used in many other ISO 9001-based standards such as ISO/TS 16949 and AS9100. Integrating these tools as part of the product planning process will provide a solid foundation for the engineering and production of medical devices.

For more information on ISO 13485 and ISO 14971, contact G3 Solutions at 810-632-9850.

ISO 14001 implementation – worth the effort!

Thursday, January 22nd, 2009

Many times we often hear comments about the commonalities between ISO 14001 and ISO 9001. Both standards have such requirements as management review, corrective & preventive action, internal audits, document control, and a top level policy statement. While there are many seemingly identical components, it should not be assumed that it is easy to implement an EMS because of these similarities. Many companies make the mistake in assuming that implementing 14001 will be a walk in the park since they have a quality management system.

Just because a company may not have an inventory of hazardous waste, there are still countless ways that an organization can have an impact on its surrounding environment, even if the organization’s site is comprised of nothing more than a few desks and computers.

Identifying all of the potential aspects and impacts of a company can be a very challenging task regardless of the product or service created. It is also the key first step to success in implementing an effective environmental management system.

Once these aspects and impacts are fully identified, a company can then move forward and implement programs that can be used to minimize any negative impacts on the environment. Some companies implement programs to pro-actively create positive impacts. They may even find out that helping the environment can be a profitable venture! Reductions in waste can very often show up quickly as cost savings in such areas as resources and utilities – and that’s a bonus in any type of environment!

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.


ISO Internal Audits – can they be done by an outside party?

Saturday, January 10th, 2009

Many companies are choosing to outsource their internal audit process because of various resource issues within the organization. A number of reasons for this trend are becoming more common throughout many industries.

After spending large sums of money training a pool of good internal auditor candidates, an organization may find that some within that group take on new positions and responsibilities that either do not allow time for conducting internal audits or they are no longer able to audit certain areas because of their new role. Some employees will leave the organization and some will just decide that internal auditing is not for them. This is especially true in companies that are registered to such standards as ISO/TS 16949, AS9100 and other industry specific standards based on ISO 9001. The methods needed for conducting internal audits in these standards can be rather time consuming in terms of preparation.

Another reason is that some companies will use a large pool of internal auditors where most of them may only get a chance to audit one time per year. For small companies with simple processes, this isn’t a big deal. For other organizations that have a multitude of key processes and departments, the auditing process can lose its effectiveness because of a lack of auditing experience by the internal auditor.

If your internal audit program has stalled and surveillance audits are approaching, let G3 Solutions show you how to ease the burden of having limited time for a complex internal audit schedule. Not only can G3 Solutions auditors pinpoint critical areas and nonconformances, G3 Solutions consultants and auditors can provide expertise in helping your organization develop cost-saving strategies to implement as part of the corrective action.