Author Archive

Integration Dr. in Quality Digest

Our very own Mary McDonald a.k.a. The Integration Dr. currently has an article published on QualityDigest.com about taking an objective look at your management system. It’s a great read for anyone interested in improving their system, whether its integrated or not. I highly recommend it, here is a direct link to the article. If you have any thoughts or comments on the article feel free to discuss in the comments here.

13

05 2010

Integrating Records Control

As we continue to review specific element integration, Control of Records is a wise choice for further integration consideration.  Although the records will often refer only to one standard (pH of wastewater, incoming inspection quality, recordable accidents), the way we choose to control these records may be the same.

The standards state:
The organization shall establish and maintain records as necessary to demonstrate conformity to the requirements of its [standard] management system and of this International Standard, and the results achieved.
The organization shall establish, implement and maintain a procedure(s) for the identification, storage, protection, retrieval, retention and disposal of records. Records shall be and remain legible, identifiable and traceable.

ISO 9001 also requires that this be documented (one of the six documented procedures)

Where do we spend our time?  On that list of requirements embedded into the standard:

-       Identification
-       Storage
-       Protection
-       Retrieval
-       Retention, and
-       Disposal

Why do we focus our integration efforts here?  Because we want to make a procedure that is flexible enough to handle lab records, incoming inspection records, and legal/regulatory records; without being so bureaucratic that it bogs down the work itself.  Our records need to be kept, in order to demonstrate conformance to requirements and compliance with legal and regulatory requirements; our focus is on making this process as comprehensive, yet streamlined, as we can.

How you choose to handle the bulleted list above, and the integration, is dependent on corporate culture to a large extent.  Some organizations I work with are entirely electronic – nothing resides in paper.  Other groups have paper records, job travelers, shipping documents, etc. that are still filed/stored in cabinets, files, or in desk drawers.  Neither one is better than the other, since this method and system works for this particular organization.  So start by looking at what documents are created; determine the answer to the bulleted list for each one, and go from there.  The trick for this element is not so much the documentation of the process as defining a process with sufficient rigor yet flexibility.  Feel free to contact us at info@mcdcg.com if you’d like to dive into this topic a bit more!

10

05 2010

Integrating Document Control

We’ve talked about how systems can be integrated; let’s talk about how specific elements of systems can be integrated.  Today’s topic is Document Control – the control of documentation to ensure that documented procedures are available at points of use, approved prior to use, obsolete documents are removed to prevent unintended use, etc.

How can we start to implement Document Control?  The first step is to identify which documents require document control.   ISO refers to documents “necessary to control the process” or that “affects conformity to the standard”.  Talking about straight ISO requirements (without additional industry-specific requirements), there are six required documented procedures for ISO 9001 (ping me if you’re unsure which procedures they are); the requirements for EMS and OHS are not called out as documented specifically.  For any documents that we determine we do need to control, we must control them per our own documented requirements.

All standards call out the following requirements:

The organization shall establish, implement and maintain a procedure(s) to

a) approve documents for adequacy prior to issue,

b) review and update as necessary and re-approve documents,

c) ensure that changes and the current revision status of documents are identified,

d) ensure that relevant versions of applicable documents are available at points of use,

e) ensure that documents remain legible and readily identifiable,

ISO 9001 and OHSAS 18001 add in two additional requirements:

f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system / OH&S management system are identified and their distribution controlled, and

g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

And, ISO 9001 requires that this be documented in a procedure.

Given that their text is identical for a) through e), it is easy to understand how implementing one document control system, that meets requirements of multiple standards, is where we might want to start.

Your procedure needs to address how your organization meets these requirements.  Although templates are available (I use a framework template with my consulting clients), these templates should be used solely as guidance rather than as wholesale implementation, with no thought to what they mean.

What documents of external origin do you have?  Do you have customer prints, specs, etc?  How about standards that you may need to operate (IPC, UL, CSA, DOT, FDA, etc.)?  How do you ensure that you have the most up to date copy of these documents?  How often are they checked for revision?  What is the process to do so, and who has that responsibility?

What level of documentation do you need to control – high level documents and required procedures only?  Work instructions?  Forms?  Your control should be adequate to ensure that document changes, distribution, etc. is in place.

Document control is a good starting place for integration; our next blog post will talk about Records control (which ISO defines as a special type of document).

03

05 2010

The Link Between Sustainability and Integration

To become a sustainable business you have to take into account many factors outside the purely economic impacts that typically govern business decisions. Additional factors include environmental impacts, social impacts, and the impact that a decision will have on your work force. This is what is sometimes referred to as the triple bottom line of, people, planet and profit. When striving for sustainability, organizations have to value all parts of this triple bottom line equally, meaning they cannot chose to focus on increasing one aspect at the expense of the others. In short, sustainability requires us to consider all the impacts our decisions will have, and because of this need to monitor the affect on more than just a single aspect of the business, integrated management systems can help lead to better business sustainability.

In an integrated management system the same people are responsible for several different aspects of your business; and because of this, they are in a unique position to help increase the sustainability of your business. By implementing an integrated management system, you will be well positioned to take on the challenge of long-term sustainability. When you integrate your management systems, you will go from having quality staff, environmental staff, and health and safety staff, each with their own set of procedures and processes, to having one group of management system staff that can handle all three of these aspects. These cross-trained employees will automatically begin thinking in sustainable ways because of their diversified focus – when looking at a quality issue they will also consider the environmental or health and safety impacts of any possible solution.

Beyond this inherent benefit to sustainability from integrated management systems, integration will also make it easier for other employees to make sustainable business decisions. One of the challenges many sustainable businesses face is trying to take into account the sometimes competing environmental, community and employee impacts of business decisions.  Determining the pros and cons of each of these decisions with respect to the different criteria can be a very time-consuming exercise.  This may involve checking with several different people from different departments and then synthesizing all of their inputs; however, in an integrated system, this process becomes much simpler. In an integrated system you will more than likely talk to one person to get information on a majority if not all of the aspects you are trying to take into account. By reducing the number of people who have to be contacted, you significantly reduce the strain that a new sustainability effort puts on managers and other decisions makers in the company.

Beyond this simple reduction in the number of people that need to be contacted, the advice you get will also be more usable. In a non-integrated system you would get input from a quality person, or an environmental person, who will only give you one side of the story because that is all they have been trained to look at. In an integrated system however you will get advice from someone who is used to considering multiple areas of impact and balancing them against each other to create an optimal solution. This makes the job of interpreting the sustainability advice much easier for managers and other decision makers in the company, further reducing the burden that a new sustainability effort will put on your company.

Integrating your management system can be a great first step toward a more sustainable business and will make the transition to sustainable business practices easier. Adopting a triple bottom line mentality will always require some serious shifts within an organization but integrating will help you minimize the strain these shifts put on your personnel and will help set you on a path to sustainable business success.

29

04 2010