The Integration Dr Blog

Several industries have developed industry-specific standards, which address their unique requirements while using ISO 9001 as a baseline for additions.

These industry-specific standards typically require more prescribed methods, forms, or processes than ISO 9001; in return for loss of flexibility, organizations will be more standardized, meet stricter or additional requirements, but also qualify for orders from industry-specific OEMs and higher level suppliers.

AS 91X0 – Aerospace standards, for suppliers, and stockists (distributors)

ISO/TS 16949 – Automotive requirements for quality

TL 9000 – Telecom requirements for quality

ISO 13485 – for medical devices

How do these standards integrate?

For ISO 9001 – ISO 9001 is used, in its entirety, as a basis for the standards.  When implementing any of these standards, ISO 9001 requirements will be met as part of the implementation, so no additional effort is required to conform with ISO 9001.

ISO 14001 – ISO 14001 is no more difficult to integrate with these standards than integrating with ISO 9001; however, there is no/limited additional benefit to integrating ISO 14001 with an industry standard vs. ISO 9001.

OHSAS 18001 – Since these industry-specific standards may also consider risk as part of their assessment, it may be easier to implement OHSAS with these standards; the concept of risk assessment and risk management are resident in the organization and can easily be extended to the risk elements of OHSAS 18001.

What are your thoughts on integration with these industry-specific standards?  Do you agree that these standards are better aligned with OHSAS?  Have you integrated ISO 14001 or OHSAS 18001 with an industry-specific standard?

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!

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).

An EMS is put in place to provide a system for an organization to manage and control their environmental aspects and impacts.

Environmental Management Systems are structured around the following:

- identification of an organization’s significant aspects, and their environmental impacts;

- a policy, supported by plans and objectives, and their targets;

- continual improvement of their environmental performance

- records of environmental performance and achievement of targets

What is ’significant’?  This is sometimes the $64,000 question.  There are many ways that an organization may determine significance — they can identify all aspects/impacts, and rank in order of severity, and work on the top xx%; they can set an objective limit – everything above that limit is considered significant; or any other myriad ways of determining what is significant.  A future post will talk about different tools that are available to make this task less cumbersome…

What the organization should NOT do is to ‘play the game’ with significant aspects/impacts.  One company I visited, which used some pretty nasty chemicals, and was located in an environmentally sensitive area, chose to say that only water – yes, H2O – was significant, since “We use so much more water than we do chemicals”.  OK, that was true – they use tens of thousands of gallons of water – to wash their parts from all these nasty chems, because if an employee was to touch these chems they would receive an immediate chemical burn!  Although I ‘discussed’ with them the severity of the environmental impact results of these chemicals – much more environmentally damaging if spilled than water, as an example – I could not dissuade them from listing water as their only significant environmental aspect.  Needless to say, at the end of the day we mutually agreed to part ways… because I’m not about playing the game; I’m about making a positive environmental impact.

Is an EMS implemented uniformly throughout the world?  Unfortunately, no.  There are many organizations where EMS is a way of life; and the Europeans have been ahead of much of the rest of the world in implementing environmental and sustainable systems.  [I remember traveling to Germany in 1987 and being introduced to paper recycling in the office...]  In other parts of the world, rivers are still treated as a dumping ground for sewage, chemicals, and garbage; and there are little or no environmental controls in place while performing operations including mining, logging, or fishing.

However, the future is not totally bleak – there are more countries supporting implementation of EMSs than ever, and more organizations are implementing EMS and finding the satisfaction of reaping both financial and environmental benefits from it.

We can take a sustainable approach in many different ways—and integrate with our current management systems at the same time.

In the international standard on quality management systems, ISO 9001, we are tasked to minimize waste through higher initial quality, continual improvement of our processes, repurposing (repair, rework, re-categorize), and advance planning. If we take this concept a bit further, we can see that sustainability integrates into a system in areas of continual improvement, opportunities for improvement, and preventive actions. We can focus on what we can do to minimize our footprint that will also result in benefits to our materials stream.

In the environmental management systems standard, ISO 14001, we are tasked, in addition to many of the same clauses as noted above, to have a commitment to prevention of pollution. This concept is much broader than simply trying not to pollute—prevention of pollution goes much further, asking us to consider, in the design phase, whether we can make choices that will minimize our impact on the environment. As defined in ISO 14001:

“Prevention of pollution: use of processes, practices, techniques, materials, products, services or energy to avoid, reduce, or control (separately or in combination) the creation, emission, or discharge of any type of pollutant or waste, in order to reduce adverse environmental impacts.

NOTE: Prevention of pollution can include source reduction or elimination, process, product or service changes, efficient use of resources, material and energy substitution, reuse, recovery, recycling, reclamation, and treatment.”

This is linked hand-in-glove with sustainability—ensuring that we have the resources necessary to continue our work in the future, by wisely using our current resources. In fact, we are tasked with considering this while our design is still on paper—researching alternatives, selecting renewable resources that are not in danger of disappearing, etc.

Okay, we see how we might be able to involve sustainability in our management systems theoretically. How can this be applied to our businesses today—how can we help to assure that the trends noted in the Copenhagen Climate Council report decelerate, or better yet, neutralize and reverse?

1. We can be aware of our effect on the environment. Where are our raw materials coming from, and are they sourced sustainably? Are they of sufficient quality to allow us to manufacture parts of high quality without rework or waste? How about our equipment—is it energy efficient? Are we running as efficiently as we can, at a system level (we are optimized for overall rather than at sub-system levels)? Are we increasing the temperature of the water that we’re discharging, even if the waste stream has been neutralized?

2. We can encourage our employees to participate in our initiatives. One company I have a lot of respect for is Silicon Laboratories in Austin, Texas. They looked at their environmental impact and made significant changes to the way that they operate, including:

1. Moving their facility to a less environmentally-sensitive part of town instead of expanding in their old facility, near an aquifer,
2. Buying renewable energy,
3. Eliminating plastic bottles (300,000 annually!) from their facility vending machines–and providing reusable nalgene bottles to their employees for filtered water instead,
4. Cutting the electrical costs in half by smartly heating and cooling their facilities and turning off most lights during off hours,
5. Using environmentally-friendly materials to build out their new office infrastructure,
6. Providing recycling stations throughout the building, including in every meeting room,
7. Sponsoring green programs within their city.
8. Replacing stationery and other paper materials with recycled equivalents
9. Giving employees a reusable grocery sack and a coffee mug made from recycled materials to get them thinking about reuse instead of one time use

10.  Creating a Green Team of employee volunteers whose goal is to continue to identify earth friendly business practices

3. We can change at the personal level. Three years ago, it was a rarity to see people walking out of our local grocery store with anything except white plastic bags provided by the store. Now our car has reusable mesh, canvas, and plastic bags in the trunk, which we regularly bring into the store with us. We recycle (our city makes it easy by providing curbside recycling, but at our prior home, I’d happily collect/sort our recyclables—paper, plastics, and glass—in the garage and make a recycling run about once a month to the collection facility). We set the temperature a bit higher in the summer, and lower in the winter; turn off running water; unplug electrical chargers/converters when not in use (those big “bricks” attached to electronics, as well as the smaller phone charger plugs, use electricity even when not charging—if it’s bigger than a three-prong plug, unplug it when not in use); and a dozen other things—all without affecting our lifestyle significantly. In my new neighborhood, I’ve encouraged those in our cul-de-sac to recycle more and we’ve been able to reduce our trash significantly. Will this make a difference on a global level? I don’t know, but it won’t be a negative impact, and that’s a step in the right direction.