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?

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!

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!

Let’s presume that you are working a problem in your facility – the problem is a rather thorny one, and is affecting multiple management standards.  How should you handle the root cause determination, and the corrective action resulting from it?  For reporting purposes, how do you report it for metrics – as a problem in all three metrics?  Do you pick one and let the other standard metrics alone?  What’s the best way to handle this?

Here’s a hypothetical problem:  you’ve noticed that a chemical used in your facility has been used up  prematurely, so there is insufficient quantities to maintain production; you investigate further and discover that an employee was trying to attach a hose without the correct safety equipment and process equipment in place, and he was injured; before he could turn off the valve, the chemical poured out onto the tank farm floor, resulting in a chemical spill.  The resulting problem affects the product quality, employee safety and health, and requires a chemical spill cleanup – so we’ve got an impact from a QMS, OHS, and EMS standpoint.  What’s the best way to handle the root cause determination, and the interim and final corrective action(CA) ?

Our first step is the put an interim CA in place to ’stop the bleeding’.  Our first concern is the employee   – let’s make sure that they’re safe and getting the attention they need.  Ensure that all safety precautions are in place, then institute chemical spill cleanup per your environmental procedures and following manufacturer and MSDS recommendation, paying particular attention to containment and prevention of chemical down drains that lead to water supplies, or out the door and to the soil.  Now that we’ve got the basics covered in the short term, we want to focus on a) understanding why this happened, and b) ensuring that this won’t happen again.  In order to do that ’smartly’, we want to assemble a small team from the major groups affected, to step through a formal corrective action process — determine the root cause — in this case, determine how the spill happened in the first place.  The team should also determine what permanent CA will be implemented, and take steps to put the permanent CA in motion (ordering new supplies, reviewing spill procedures, safety procedures, etc. and determining what will ensure that this problem won’t happen again, for this reason).  Finally, the org should determine what steps need to be taken to prevent this in the future (preventing this from happening for other reasons), and what this impact may have to product quality.  Do customers need to be notified that shipments may be delayed?  Can an expedited shipment of the chemical be ordered and delivered?

Now let’s take a minute to go back and review:

- Quality is affected – shortfall of one of the raw materials

Fix:  investigate expedited delivery

- improper handling resulted in a chemical spill – both environmental and occupational health and safety implications

Fix:  review the existing environmental and safety procedures; update as required;

- Preventive action:  how could a spill have happened if not this way?  How could an employee have been injured if not this way?  How could our product quality have been affected if not this way?

Is there anything we’ve forgotten?  Anything you’d do differently?  Let me know – I’d love to hear your comments!

A Quality Management System (QMS) is put in place by an organization to provide a framework for their quality initiatives.  A QMS typically consists of the following elements:

• Quality Policy
• Quality Objectives
• Quality Plans
• Required procedures
• Quality Records

One of the first questions I get from clients is:  “Where should I start with all this?”  My answer depends on why the organization is trying to implement a quality standard.  Is it to:

• become certified?  –> Start with the ISO 9001 standard
• understand their processes?  –> Start with process mapping and analysis
• meet a customer requirement?  –>  Understand what the client is looking for
• want improvement? –> Consider what info is currently available, and go from there.  You may have the info you need already, or that information/data may need to be generated prior to embarking on improvement efforts…

The typical elements of a QMS:

• Management commitment
• Resource allocation (human, technology, $$)
• Process/service realization and delivery
• Checking/verification (can be via data or records, inspections, audits, etc.)
• Continual Improvement (CI)

In addition, there are several support processes that make this possible:  shipping, receiving, purchasing, accounting, invoicing, finance, HR, etc.

A QMS will have some form of the elements listed here – and virtually all QMSs have these elements – whether the model used includes ISO, Performance Excellence (Baldrige), or other methodologies.

If focusing more on improvement, business process mapping and analysis (BPM/BPA), Lean and Six Sigma, and other tools may be better suited.

There is some concern that implementing a QMS is bureaucratic, time-consuming, and difficult.  I’ve seen this first-hand – when an organization doesn’t begin with the end in mind (to quote Covey), it will implement a hodge-podge of procedures, formats, records, etc. and provide little or no overall direction to its people – either implementers or the rank and file.  Where I see this the most is when top management decides that they need a QMS – then abdicates the responsibility.  Not delegates, which implies that they have assigned this to someone else, but are available to provide clarification, direction, and resources; but instead, they assign it to “Joe”, who then has to figure out what’s going on, how this is going to work, and try and use informal power (working with peers, subordinates, and superiors) to bring this program to fruition.  Poor Joe may have no management support on this – which means that the program is doomed from the start.

In contrast, when top management is engaged in the implementation of a QMS, it’s a beauty to behold.  There is clear direction on not only what the organization is doing, but why; and this makes all the difference.  Top managers are looking for status updates, providing resources as needed, and supporting Joe as he implements all the facets of a QMS in the organization.  A recent client told me that he was implementing a QMS because “it’s the right thing to do – and will also save us money!”… my kinda client!  And, we are integrating Process Improvement techniques into his QMS from the beginning – so we are streamlining as we implement!  I’ll keep you posted on our progress…

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