ISO 14001 / EMS Compliance Update - Reach Regulations Update

REACH has 20 New SVHCs with One Endocrine Disruptor

There are four key takeaways from the recent REACH news that 20 new chemicals have been added to the Candidate List for a total of 73:

1.    Companies need to review the chemicals they use in their products and processes and compare to the list of 20 new and 73 total chemicals on the reach list.

2.    If you do not have the chemicals in your operations or if your products are not exported to Europe, then you do not need to do anything further.

3.    If you have the chemicals in your products then you need to determine how much is exported to Europe.  Companies need to notify ECHA of uses around 20 new chemicals, deadline: June 2012

4.    endocrine disruptor chemicals are making the List – These are Plasticizers  

5.    New chemicals may be added to the list more quickly in the future, so if you ship to Europe, or your products are exported to Europe, you want to keep up to date with this list

Endocrine Disrupting Chemicals

Octylphenol is the first Endocrine Disrupting Chemical (EDC) to be added to the REACH SVHC list.

Here is a list of other EDC’s

Companies can help ensure they’re prepared for any changes to the SVHC list by collecting supplier data on chemical ingredients as part of their ISO 14001 management systems

There are 73 SVHCs now

With 73 chemicals now listed, companies need to review the chemicals in mixtures and in articles.

The Criteria for this includes, but is not limited to:

Producers and importers of articles have six months from today to notify ECHA by 19 June 2012 if both of the following conditions apply:

· the substance is present in those articles in quantities totaling over one tonne per producer or importer per year

and

· the substance is present in those articles above a concentration of 0.1 % weight by weight

There are exemptions from the notification obligation if the substance is already registered for the use or when exposure can be excluded.

The 20 new chemicals on the REACH Candidate List are:

1.    Zirconia Aluminosilicate Refractory Ceramic Fibres

2.    Calcium arsenate

3.    Bis(2-methoxyethyl) ether

4.    Aluminosilicate Refractory Ceramic Fibres

5.    Potassium hydroxyoctaoxodizincatedichromate

6.    Lead dipicrate

7.    N,N-dimethylacetamide

8.    Arsenic acid

9.    2-Methoxyaniline; o-Anisidine

10. Trilead diarsenate

11. 1,2-dichloroethane

12. Pentazinc chromate octahydroxide

13. 4-(1,1,3,3-tetramethylbutyl)phenol

14. Formaldehyde, oligomeric reaction products with aniline

15. Bis(2-methoxyethyl) phthalate

16. Lead diazide, Lead azide

17. Lead styphnate

18. 2,2'-dichloro-4,4'-methylenedianiline

19. Phenolphthalein

20. Dichromium tris(chromate)

Link to full list of 73 chemicals: 

http://echa.europa.eu/web/guest/candidate-list-table

You Cannot Multitask!

Effective Multitasking is an oxymoron I have been well aware of for some time. My own personal experience has shown that we do not actually multitask we just switch from task to task, Interrupting ourselves and losing productivity in the process. In time management training we call this an interruption. I have also watched project managers, quality managers, supervisors and managers try to multitask regularly and significantly reduce their own productivity.

This is why in my time & project management training workshops I instruct participants to schedule blocks of time for items that might otherwise be multitasked such as updating project schedules and action item lists as well as scheduling planning time for each day.

If you are Multitasking, you are reducing your IQ twice as much as smoking Pot:

A study, carried out at the Institute of Psychiatry, found excessive use of technology reduced workers' intelligence - Those distracted by incoming email and phone calls saw a 10-point fall in their IQ - more than twice that found in studies of the impact of smoking marijuana, said researchers or about the same amount as not sleeping at all for an entire night.

How many tasks can we focus on effectively (1 or 2 maximum):

The pioneer of this research is Professor Earl Miller, a neuroscientist at the world-renowned Massachusetts Institute of Technology. He scanned volunteers’ heads while they performed different tasks and found that when there is a group of visual stimulants in front of you, only one or two things tend to activate your brain, indicating we’re really only focusing on
one or two items.

But I am working faster when I Multitask:

An American study reported in the Journal Of Experimental Psychology found that it took students far longer to solve complicated math problems when they had to switch to other tasks - in fact, they were up to 40 percent slower.

Ever wonder why you are grumpier or less satisfied when you try to multitask? (And this is over and above the items previously listed)

Studies by Gloria Mark, an ‘interruption scientist’ at the University of California, show that when people are frequently diverted from one task to another, they work faster, but produce less. After 20 minutes of interrupted performance, people report significantly higher stress levels, frustration, workload, effort and pressure.

So you work faster, but get less done and are more stressed!

But I Am Experienced and Good At Multitasking (Practice makes perfect):

This is a Misnomer – Research has actually proved that people who try to multitask a lot are actually less effective and efficient at it than people who do it once in a while (Cognitive control in media multitaskers - Edited by Michael I. Posner, University of Oregon, Eugene, OR, and approved July 20, 2009 (received for review April 1, 2009)


Aren’t Women supposed to be better at Multitasking than Men?

Incidentally, such research - like the bulk of scientific investigation into the brain - reveals no significant difference between the sexes. The widespread belief that women’s brains are
naturally better at multi-tasking seems to be a myth.

The evidence shows that women’s apparent multi-tasking superiority is down to the fact they are happier to try doing several things at once.

How about our Children?

Multitasking is actually bad for a child's intellectual development. This growing problem has been christened 'attention deficit trait' by psychiatrist Edward Hallowell. 'As our minds fill
with noise, the brain gradually loses its capacity to attend fully and gradually to anything,' he argues.

Such scatterbrained attention-swinging may be causing a form of autism among children growing up immersed in technology, affecting their ability to interact with others.

This should be a call to action to help our children learn to focus on individual task completion and to help them learn to cut out distractions


So what can I or should I do?

1. Turn off your e-mail alert
2. Check your e-mail at certain times during the day
3. Schedule important tasks and block out distractions during those times
4. Communicate with your team members and coworkers that there are certain times of the day when you're not to be disrupted unless it's an emergency (You need to do this in a tactful manner)
5. If the noise around you is distracting consider using earplugs
6. Reduce the duration of meetings. Ask participants to refrain from using smart phones or e-mail during the meeting and stay focused on the meeting agenda.

Here is an additional article from the Harvard Business Journal:

How (and Why) to Stop Multitasking:

http://blogs.hbr.org/bregman/2010/05/how-and-why-to-stop-multitaski.html

Process Improvement SPICE, ISO 15504, CMMI & SCRUM

Most people do not realize the complexity of developing software. Many current companies are producing software that is embedded in hardware. This software has grown exponentially over the past several years and while these same companies have the experience of building the associated hardware for many years, the embedded software processes are not as mature.

As the software has become more complex, many of the processes of requirements analysis and testing has, in many cases not kept pace. This results in a process of developing software that is not well controlled and leads to inconsistent results.

Some recent projects we have been working on have been to help companies improve their development processes for software and in achieving SPICE & CMMI Level 2 and Level 3.

While much of this article and examples are specific to software processes, the project management and control described below contains approaches and lessons for most companies and organizations.

Approaches,

Companies approach process improvement typically in two ways and most times a combination of both. One is a drive to improve processes to eliminate issues that reoccur and cause significant pain within the organization. The second is to meet requirements placed on the organization by their customers and contracts.

In either case a company should begin by addressing the process areas that are the bottlenecks and factors that limit the efficiency, effectiveness, and quality of their end product.

The areas we have been focusing on recently come from the Automotive SPICE Scope:

System requirements analysis (ENG.2)
System architectural design (ENG.3)
Software requirements analysis (ENG.4)
Software design (ENG.5)
Software construction (ENG.6)
Software integration (ENG.7)
Software testing (ENG.8)
System integration (ENG.9)
System testing (ENG.10)
Quality assurance (SUP.1)
Configuration management (SUP.8)
Problem resolution management (SUP.9)
Change request management (SUP.10)
Project management (MAN.3)

Most of the projects we are working have a capability of between Level 1 and Level 3. The Levels are (With my descriptions in parenthesis):

Level 0: Incomplete (You may perform many, but not all the required items)
Level 1: Performed (You do the all of the required items)
Level 2: Managed (You plan and do the required items)
Level 3: Established (You have a formal standard process established that you apply to all projects and you measure the performance)

Since to achieve a level 2 or 3 project planning and management is so important, we will discuss this first.

To achieve the intended process outcomes in this area, all work must be planned. There must be specific resources assigned and these resources must not be completely overloaded.

Many of the standard project management skills and tools are used to meet this requirement. Especially with software and other technical projects, the project management function is typically a responsibility of technical staff that have responsibilities for a significant portion of the tasks in a project. When a project management is overloaded, the first thing typically omitted is the project management activities which can drastically affect the project later.

There are many methods to address this challenge and we have specifically worked with several.

We have recently been experimenting with the SCRUM software development process, within the overall product development process driven by customer deliverables, with a great degree of success. We are finding resource and timing issues much earlier in the project, which allows for faster and more effective project adjustments. Additionally software bugs and testing issues are detected earlier.

The SCRUM process also breaks down the project into smaller “Bite” sized chucks which can be more easily managed.

However, there still has to be a focus, plan and measures toward the next deliverable and beyond. Without this, the resources may not be making progress at a rate to meet the required dates with the agreed software completion milestones. This key item must not be overlooked.

Here is a excerpt from an article about Windows 7. Do you see any of the SPICE process focus items as a reason for the improvements over the Vista project?

“Ballmer claims to have learned something from Vista: It's no longer advisable to try a "big bang" rollout — i.e., completely reimagine a product as sophisticated and interconnected as Windows.
So he hit control-alt-delete. He brought in a new taskmaster, Steven Sinofsky, to oversee the engineering. Sinofsky became known for hitting deadlines while overseeing the Office group from 2000–07. …..," he says. "What we did was [give] the development team a clarity that was probably missing." With Vista, teams worked on features simultaneously without an awareness of other schedules. When separate features came together, they were often incompatible. "The goal was to produce a plan for features, but not just a plan — also the motivation, the business rationale," the executive says.
The entire set of requirements in SPICE focuses on ensuring that the items mentioned, as well as others, are managed and successful.

Like many quality and management system requirements, this is one tool to help drive improvement. It must be established and implemented properly or the result is inefficiency with only a partial quality improvement.

The overall key in any process improvement project is to understand first what is working well within a group as well as the issues and challenges. The next step is to build on the strengths and address the weaknesses at the same time.

ISO 9001: 2008 Changes & Revisions (PPT)

Here is a PowerPoint presentation that details the changes to ISO 9001 from the 2000 revision to the 2008 Revision. It includes some implementation advice. Here is the link

http://tinyurl.com/yebsl8y

Process Mapping: Defining Procedures, Interactions, and Improvement

We have been using process mapping techniques for over 10 years now. We use this for internal auditing, lean improvements, management system documentation and improvement, and for general training.

We have been more recently focusing on the process mapping in service industries. Some of these companies are supporting manufacturing and several in completely different business areas.

We are finding that the expertise gained in documenting and improvement of processes in manufacturing has directly applied in the service and support areas.

The goals of process mapping should include:

· Define how work is conducted
· Describe the “Who”, “What”, & “When” of a process
· Describe the interactions between different departments and groups
· Standardize important steps
· More effectively and efficiently train new people
· Pursue higher quality and efficiency
· Identify non-value added steps
· Identify bottlenecks
· Identify opportunities to combine steps
· Identify computerization opportunities

Most processes can be broken down to the following 2 types:

1. External Oriented Process
- Direct association with Customer Satisfaction
- Inputs & output overlap with Customer
- Customer has expectations / requirements to meet
2. Management & Support Processes
- Processes with internal “Customers” and requirements

When developing a process map it is critical to identify the process inputs and outputs. These include manpower, machine, materials, data…These can be used when creating the process flow within a functional area.

The next important part of the process is to document the interactions within the process to other functional areas. Once a process is established (Even when not documented) the interactions is where the issues most commonly occur. A good example is that purchasing may be very good at their process in procuring the correct materials in an agreed upon timeframe, a common issue may be that they are not notified up front when a new project is started.

These processes may also identify multiple approvals required within a project. Upon closer process review it may be determined that these approvals can be combined or some steps eliminated which would speed the process up and eliminate bottlenecks. This is a lean concept known as value stream mapping.

Some quick tips on incorporating value stream mapping concepts in a process map include:

· Record Process as it actually is
· Make a list of steps that could be simplified
· Identify responsibility
· Identify Authority
· Focus on interactions with other departments, customers, suppliers…
· Create a list of items that could be computerized
· Start a “Parking Lot” to store ideas to address later

Process maps are a much better approach to documenting processes than the traditional written procedure. They are much easier for most people to understand and can more quickly convey critical steps and interaction points.

Several Process Mapping sessions recently conducted immediately identified missed communication, non-value added steps and opportunities for improvement. In each case this initiated significant improvements for a return on investment of the time and resources for this project.

AS9100 “C” Revisions

Overall Changes and Important Additions from Revision “B” and ISO 9001.

The focus of the AS9100C requirements added to ISO 9001 is on the Aerospace & Defense Industry needs. An important point is that a company currently registered to ISO 9001 that also has automotive requirements such as APQP, FMEA & PPAP built into their system or with staff that is familiar with these requirements will have an easier time upgrading their current system.
Production Process Verification (Basically the “First Article Inspection” FAI) and Work Transfer processes are AS9100 Specific, but companies experienced in PPAP will find that they are quite prepared to meet these requirements.
The main new requirements in AS9100C focus on: Project Management, Risk Management, and changes to Configuration Management. A company with a strong, documented design and product launch process will find that they meet many of these requirements and will have appropriate process in which to add any additional items required. Companies that do not have formal processes for the above items will find a great amount of benefit in establishing and implementing these processes (Increasing efficiency & quality and reducing risk).

Registration / Certification Note: Most registrars are not expecting to be qualified to register companies to the new revision until late 2009 or early 2010. This gives companies that are currently registered to AS9100B and companies working on implementation time to address the changed requirements.

Goal and Objectives of Changes to AS9100C as defined by IAQG
· Incorporate ISO 9001: 2008 Changes
· Expand the AS9100 scope to include Aviation, Space & Defense (Land and Sea based
systems)
· Increased focus on on-time and on-quality deliveries
· Clarify where documented procedures are required
· Expansion of scope to include:

o Risk Management
o Project Management
o Configuration Management
o Critical Items and special requirements

· There was extensive stakeholder involvement in revision effort to ensure the standard was recognized by many different industry “Customers” and regulatory bodies.

Key Changes to the standard requirements: (AS9100B to AS9100C)

As defined by International Aerospace Quality Group (IAQG), there are:6 additions, 8 revisions, 3 deletions

If you would like to read the rest of the additions, revisions, and deletions, Please click here: http://msgweb.com/AS9100C.html

Services We Offer

With a combined 60 years of experience in quality and process management systems, MSG presents practical solutions to companies that are struggling to obtain their first certification or working to be certified or improve in new areas of business.

Clients rely on MSG to help with international standards that are a prerequisite to selling products and services to large multinational companies or entering foreign markets directly.

MSG clients value the firm’s simple yet thorough approaches to building quality and project management processes that do more than satisfy auditors; MSG programs can help companies achieve first-time quality and reduce waste.

Because MSG has helped hundreds of companies in industries as wide ranging as automotive manufacturing to telecommunications, the firm has a deep toolbox of instructional materials and programs.

Welcome

Welcome to the Management Solutions Group blog.