The Integration Dr Blog

Some people assume that, because I’m “The Integration Doctor”, that I advocate integration of systems in every circumstance.  People who don’t know me assume that… those who DO know me, know that I try to analyze every situation as unique, and based my recommendations based on that analysis.  Yes, integration is a good idea in many cases; let’s spend a few minutes talking about the times when integration may not be the ‘right’ answer:

1)      When the systems are too disparate to combine. Some systems are not set up to be combined easily – one area may be under regulatory control, for example, while other areas are not.  In these cases, it may become too cumbersome to combine these systems (put unnecessary records and requirements on an otherwise well running system, as example); in that case, the organization may choose to keep the systems separate.

2)      When the systems are at different levels of complexity/maturity. When a system is at a high level of complexity or maturity, and is being considered for integration into another, less evolved system, the organization may choose to keep them separate.

When have you seen examples of systems that are better off separate than integrated?  Let us know!

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?

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.

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).

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.

One of the questions I’m asked is “If my systems are working OK as they are, why should I bother to go through the time and effort (and expense) of integrating?”

It’s a valid question.  Why should something that “ain’t broke” be fixed?

The answers are varied – from increased efficiency, increased understanding by the rank and file employees that these things really all ARE connected; and to allow the system to be more aware of how a change effects the system as a whole.  For me, it’s often about sub-optimization vs. full optimization.  Let me give you an example.
Let’s assume that your business is similar to a symphony orchestra.  There are different areas of the system/orchestra that need to do what they need to do, on time, and in balance with other areas.  Just as we wouldn’t be thrilled to have the violins overpower the rest of the orchestra, and potentially ruin the sonata we are listening to, we don’t want manufacturing to overpower our balance and sub-optimize another area.  If purchasing decides to change suppliers to save a few pennies, and gets in a material that is more difficult to work with, we might see manufacturing costs rise (and even erase and negatively affect the bottom line.)  Or if manufacturing uses a different chemical, which is less expensive and therefore makes purchasing happy, it might have a bigger environmental impact (affecting how it is handled, transported, and disposed of).  What if the new chemical is more detrimental to worker health?

If each of these systems are operated independently, it may take the organization as a whole a while to understand the implications of these seemingly minor changes.  However, if there is an integrated system in place, we have a better chance of reviewing the proposed change and identifying both the positive and negative impacts of those changes, and making a decision that’s better for the ENTIRE organization, not just the organization proposing the change.  So, the integration manager can be compared to the conductor at the symphony – making sure that everyone’s playing the same song, at the proper pace/beat, and at the proper volume.  The conductor/integration manager is in charge of ensuring that all parts of the organization are working together to produce a perfectly balanced product – one that takes the Triple Bottom Line (people, profits, planet) into account.

Organizations that are implementing 3 management systems – Quality (Q), Environmental (E), and Occupational Health and Safety (OHS) – are doing it for a variety of reasons:

• they want to manage all of their requirements under one system;
• they are incorporating, combining, or reducing headcount;
• they are looking for additional savings and efficiencies;
• they are interested in providing information to their employees that are incorporated into one document

What does that one employee document look like?  It may look something like this:

Employees are to manufacture the widget to meet quality and customer specifications (see attached); using safe practice for handling chemicals including applicable PPE (personal protective equipment) – chemical resistant gloves and safety glasses; and if there is any chemical spill, appropriate steps shall be taken including containment and clean-up.

So, we’ve told the employee to make a high quality part (Q), using PPE (OHS), and what to do if there is an accidental environmental impact via spill (E).  The employee shouldn’t look at this and say, “Hey – is this a Q, E, or OHS instruction?”  They should look at it and say, “Hey, this is what I have to do to meet the requirements of my job.”  It should be seamless to them which standard they are meeting; they should meet all requirements, regardless of which standard the requirement originates from.

How to do the integration?  We know from previous posts on integrating Q and E and integrating E and OHS that there are overlapping requirements among the standards.  When implementing the trilogy of standards that are the subject of this post, it is important to remember that, while there are several areas of alignment, including management reviews, internal audits, document and records control, and corrective and preventive actions, there are also several requirements that are unique to one or two of the standards (but not the other(s)).  Therefore, it is important to identify and address the unique requirements, and ensure that they don’t get overlooked in our ecstasy of implementing an integrated system.  What are some of these requirements?  We need to address customer requirements for quality; the environmental aspects/impacts for environmental and health/safety aspects/impacts for OHS; risk management and management of change for OHS; to name a few.

I’d love to hear your comments on your integration – what worked and what didn’t?  Any tips or advice for others?  Please share!

Depending on your industry, you may be asked to integrate an Environmental (E) system with an Occupational Health and Safety (OHS) system to make your system more robust; to save time and effort; or to comply with customer requirements (to name a few of the many reasons cited for integration of E and OHS).

With the latest revisions of ISO 14001 and OHSAS 18001, integration is very easy to implement.  [A joke within the consulting field is that one standard is identical to the other with the exception of the “global replace” – and it’s not too far from wrong].  Since there is virtual identical redundancy in requirements in most cases, integration is the way to get a bigger ‘bang for the buck’.  However, there are important differences between these two standards, and you want to ensure that you are not overlooking the differences between the two standards while doing the implementation.

Unique areas of the standard: for OHS, the organization must consider acceptable risk and risk management; management of change; participation of workers; and incident investigation. For EMS, the focus is on environmental impact rather than impact to workers/safety.

Areas that are similar include a Policy (4.2); hazard (OHS) or Environmental (E) identification (4.3.1); legal and other requirements, and compliance (4.3.2 / 4.5.2); objectives and programs (4.3.3); roles and responsibility (4.4.1); competence, training, and awareness (4.4.2); communication (4.4.3); documentation (4.4.4); control of documents (4.4.5); operational control (4.4.6); emergency preparedness/response (4.4.7); measurement and monitoring (4.5.1);  nonconformity, corrective and preventive actions (4.5.3); control of records(4.5.4); internal audits (4.5.5); and management review (4.6)

You may be considering implementing Quality (Q) and Environmental (E) Systems together from scratch; or you have one of the systems in place, and are considering adding on the other system.  How can you do this?

First, read the previous post about the definition of an integrated system.  For the purposes of this post, we’re going to assume we are looking at a fully integrated system.  Fully integrated systems will have one set of documentation (policy, manual, procedures, etc); one set of records (encompassing all the quality and environmental requirements); one management system review, one integrated audit plan and schedule, etc.

So, what’s our strategy for implementing a Q and E integrated system?

1)     Understand the requirements for both standards

2)     Understand the common elements, that are the most easily integrated (because the working is virtually identical)

1. Policy
2. System Documentation (Manual)
3. Document Control
4. Records Control
5. Management Review
6. Internal Audit
7. Corrective Action
8. Preventive Action

3)     Develop a strategy of how you are going to address areas that do not have a complementary component in the other standard (for example – environmental aspects and impacts in ISO 14001; customer focus and satisfaction in ISO 9001)

4)     Develop a punch list of action items to be addressed, with the goal of implementing the system (Plan The Work)

5)     Place responsibilities (names) and targets for completion (dates) next to the action items.

6)     Implement the plan (Work The Plan), including internal audits to ensure that the implementation is effective and comprehensive.

If an organization chooses to do a partial implementation; you implement step 2, and then skip step 3 before continuing on with the balance of the list.  Partial integration is seen most often in organizations where they have separate existing Q and E functions who do not report to the same management; and where these functions are somewhat entrenched.

One method is not necessarily better than another (partial vs. full integration); it is more often which method is a better fit to the organization’s needs and goals.

Many customers are now requiring that organizations maintain multiple certifications; integrating these requirements into one system eliminates redundancy, the opportunity for error (it says abc in the quality system while the environmental system says def…); and helps employee to understand that it’s not a ‘quality’ requirement or an ‘environmental’ requirement; it’s a ‘process’ requirement or a ‘system’ requirement (in other words, these requirements are cohesive and linked).

Questions on integrating quality and environmental systems?  Contact us at info@mcdcg.com or 512-280-7175 to chat!