Posts Tagged ‘guidance’

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!

ISO 9001 – It is time to put the “document nightmare” perception away! (Part 1 of 3)

Wednesday, April 22nd, 2009

Although it is true that ISO 9001 does require documented evidence for many requirements, this should not be interpreted as needing a new document for everything you do. Many times companies can modify existing documents to provide evidence of conformity to ISO 9001 requirements. Standards such as ISO/TS 16949, AS9100, ISO 13485, ISO 14001 and others have additional requirements for added documents, but the same strategy of modifying existing documents can be used for a majority of those additional demands.

In the ISO 9001 guidance document “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008 Document: ISO/TC 176/SC 2/N525R2, October 2008″, it states “For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS. Organizations may be able to demonstrate conformity without the need for extensive documentation.

There are other recommendations for document control which we will list in future posts. Just remember that the standard gives you an incredible amount of flexibility in putting together your documentation. If you would like additional ideas on how you can control your ISO documentation, contact the experts at G3 Solutions today!

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!