ISO 7.3 Design and Development Part 2

You’ve assigned your design team, gathered your inputs and know what the outputs of your design need to be.  Now, it is time to go to work.  This is where following the ISO 9001:2008 requirements can save you time, money and headaches!

Designs are not often completed in a day or a week.  So ISO 9001 7.3.4 requires systematic reviews to ensure that the outputs are appropriate and extensive enough to meet the inputs and production needs.  Problems and opportunities are noted and actions proposed.

This is where the savings and cost avoidance occur.  It is far easier to correct issues during this phase than during production, or, heaven forbid, in the field!

While there are no specific techniques required by the standard, I strongly recommend that you use Failure Mode and Effects Analysis (FMEA) to help you identify and eliminate/mitigate design risks.

Now, onto a topic that causes a fair amount of confusion: Verification and Validation. 7.3.5 and 7.3.6.

Put simply:

Verification: Objective evidence that you are building the product “right”. Does the product meet the stated inputs?

Validation: Objective evidence that you are building the right product.  Does the product work in the customer application?

Returning to the design of Pen3000 (May 27, 2014 blog posting),

During verification phase SuperPen Inc. used prototype testing to verify that Pen3000 was able to write for 1000 m in a temperature range of -15°F to 150°F.

The requirement the Pen300 must write immediately after being “open” for 24 hours proved a bit more problematic.  The first round of testing had a 20% failure rate.  The design was reexamined and a change made to the ink type used.  Subsequent testing of the new design was successful.  Purchasing was notified of the change in requirement.

Validation ensures that the product works in the intended environment.   SuperPen sent 1000 prototype pens to their customer.  The customer, in turn, sent them out for field use and evaluation.  They worked perfectly.  The pens were then released to full scale production.

One more item.  In fulfilment of 7.3.7 and common sense, the design changes, including the specification for the ink used, that were spurred by the verification testing documented, verified, and formally approved. 

The following graphic pulls it all together:

Next time we'll discuss the key areas of purchasing and supplier relations. 

Enjoy your day!

Regards,

DonnaLynn

508-641-5930

ISO 7.3 Design and Development Part 1

Ever say, “What idiot designed this?  Did they never consider…….”  

Consider these:

A NASA orbiter was lost when no one picked up the fact that Lockheed Martin was using English units of measure while NASA used metric. Cost was $125,000,000.

The Washington State Department for Transportation had to may tens of millions of dollars to fix and change Highway 520 Bridge due to design errors

A $60,000,000 stadium in Allan, TX cannot open due to design flaws which caused inch wide cracks in the concrete concourse. 

There is lot to consider when designing and we all have desire to “just do it”.  But a rushed, haphazard design can bite, and bite hard.

A methodical approach pays off in the long run.

ISO 9001:2008 spends considerable time on Design and Development.  If Design is one of your company’s offerings, so should you.

Today’s blog will take a look at 7.3.1 through 7.3.3 Planning, Input and Outputs.

Planning:

As with all aspects of your business, ISO 9001 requires you to plan and control the design and development of your product. Specifically, you are required to:

·         Determine the design and development stages

·         Ensure that the  review, verification and validation (more on this in the next blog) are appropriate to each stage

·         Define responsibility and authority

·         Manage group interfaces and communication

Inputs:

Inputs go beyond that design on the napkin.  They must be complete, unambiguous not in conflict with each other.  They include:

·         Functional and performance criteria.

o   Pen3000 must be able to write for 1000 m in a temperature range of -15°F to 150°F.

o   Pen3000 must write immediately after being “open” of 24 hours.

·         Applicable statutory and regulatory requirements

o   TSCA

o   Meet ISO 12756 requirements

·         Information derived from previous similar designs

o   Design , manufacture and complaint history for Pen2500

Outputs:

The outputs must be able to be verified against the inputs.  Really, how else would you be sure that your design is adequate?

Design is only a step along the way to customer satisfaction and profit.  These outputs must be used by others.  Therefore the standard requires that the outputs shall:

·         Meet the input requirements

·         Provide appropriate information for purchasing, productions and service provision

o   Material specifications

o   Final Product specifications

·         Contain or reference product acceptance criteria

o   Raw Materials

o   In Process

o   Final Product

·         Specify characteristics that are essential for safe and proper use.

This may seem strict and a bit daunting.  Don't be scared off. Your process does not have to be cumbersome, just methodical. 

We’ll review the remainder of the Design and Development clause the next time.

As always, we’re here to help with any of your Quality System needs.

Be well,

DonnaLynn

ISO 7.2.2 &7.2.3 Contract Review and Customer Communication

Stop before you take that order or sign that contract!

Common sense and ISO 9001:2008 require you to review and ensure that you can fill all requirements before the order is accepted (even if this is repeat order).

1.       Make sure that the product requirements are defined. (see April 23 Blog on Product Requirements)

2.       Ensure that all conflicts are resolved.  This includes delivery dates and quantity.   

3.       Ensure that you have the ability to meet the requirements as defined

Records are the review and resulting actions must be kept.

Should something change, say your customer pulls in the order date, you must ensure that all relevant documents are amended and the appropriate people notified.

One note:  In some cases, such as internet sales for catalogue items, a formal review is not needed.  The catalogue itself or advertising material can be used as evidence.

Customer communication goes hand in hand with this. You are required to determine and implement effective process communicating the following with your customers:

1.       Product information

2.       Enquires, contract and order handing

3.       Complaints or other feedback

Carrie’s Catering Does It Right

Carrie’s Catering serves Cape Cod area events for up to 500 people. The company has an interactive website to showcase available services and allow for the initial inquires as well as a vehicle for both customer testimonials and complaints.

Once the initial contact has been made via the website, phone or in person, Carrie or her assistant sits down with each potential client to define all product requirements including venue, dietary requirements, date, service requirements and any additional requirements

She then reviews these requirements with the appropriate people on staff and writes up the formal contract which is reviewed with and signed off by the client.

And changes must be requested in writing and approved by both parties.

This careful planning and attention to detail ensure provides Carrie with the information needed to provide for a spectacular event, delighted customers, and great word of mouth advertisement.

She does both her Beef Wellington and her contract review right! 

Next time, our ISO 9001 primer will take us to Design and Development.

Remember, we are always here to help your business with its own Quality Journey

Regards,

DonnaLynn

ISO 9001:2008 Section 7 Product Realization Product Requirements

ISO 9001:2008 has you look at product requirements from several angles.

To really understand the product requirements, understand how your product will be used.  If possible, talk with your customer.  Let’s see how this would apply to both a physical and service product.

Sal’s ceramics is selling custom coffee mugs:

Specification:  Base mug PN 1232, cobalt blue with the company logo

Delivery: 1000 mugs delivered by UPS by October 1.

Post Delivery: none (This often applies to machine set up or instruction)

Requirements not stated by the customer: Clay body and glaze type

Statutory and Regulatory: Glaze must food safe FDA has guidance document

Any other requirements: Firing schedule

Ball Limo service’s primary customer base is executive transportation.

Specification: Clean, safe chauffeur driven limousine or other specialty car

Delivery: On time pick up defined as 0 minutes late, 20 minutes early

Post Delivery: Provision of annual, detailed summary of all trips

Requirements not stated by the customer: GPS in each vehicle

Statutory and Regulatory: State inspections

Any other requirements: All drivers trained in defensive driving techniques

What are your product requirements?  Put yourself in your customer’s shoes.  They range from the physical specifications to your return policy.

Industry leaders understand and deliver on all customer requirements.

In plain English: you need to take the time and put in the effort to understand your product, how it is used and just what your customer expects.  It is well worth the effort!

Next time we’ll take a look at contract review and customer communication.

As always, please contact us at 508-641-5930 for any of your Quality Management needs.  

Regards,

DonnaLynn

ISO 9001:2008 Section 7 Product Realization….let's begin...

When people first read ISO 9001:2008 Section 7, Product Realization, they often get glassy eyed.

Some insist that it doesn’t apply to them.  It does.   

Now, how  your business meets the requirements is up to you.  A 5,000 person firm with multiple products will have a very different system than the 20 person machine shop or the 5 person travel agency.

The graphic below shows the various elements.

Note:  if you do not do any design work, you can take and exemption to Clause 7.3

We’ll explore these in more detail in future blogs, but I want to go over one key point:

What is a product?

A chair?  True

A train ride? True

An on dating service? True

A motor? True

An Adhesive? True

A product is simply the result of a process. A process turns inputs into outputs.

If you are reading this blog, you have a product. That makes it important that you understand the Product Realization Section.

Product Realization is really about three things:

a.       Understanding the output

b.      Understanding the inputs

c.       Planning and controlling how you get from the inputs to the output

That’s it for today.  Please give us a call at 508-641-5930 or complete the contact sheet for any of your Quality Management needs.  We’ll be glad to come in and work out a solution.

Regards,

DonnaLynn

ISO 9001:2008 Clause 6 (Part 2) Infrastructure & Work Environment

ISO9001:2008 requires that the organization “determine and provide the resources needed to implement and maintain the Quality Management System and continually improve its effectiveness, and enhance customer satisfaction by meeting customer requirements”  Ensuring the availability of resources is a key part of Management Responsibility.  Clause 6 breaks resources into three sections:

·         People

·         Facilities

·         Information Infrastructure

In our last post we talked about human resources. Now let’s turn our attention to facilities and infrastructure.  Think of Clause 6 as a disaster-protection plan. Most people don’t consider infrastructure until it fails. The power goes out. Your computer crashes.  The delivery truck doesn’t pass inspection. ISO 9001:2008 requires that you determine, provide and maintain the appropriate infrastructure for your business, and in doing so, it helps you anticipate problems.

We’ll use the Auto Body Shop as an example again. Some of the infrastructure for the Auto Body Shop includes:

·         The building with three bays, lifts, an office and customer waiting area

·         Waste collection system, electronic diagnostic equipment

·         IT network

·         Computers and printers

·         Pick-up truck

The owner, John Frace, has established an in house preventative maintenance system for the repair area and outsources the maintenance of the computer system.  All files are backed up to the cloud on a daily basis. The truck is maintained in house

The work environment (6.4) is a combination of the physical environment (light, heating, air quality etc.) and human factors such as use of personal protection equipment and good ergonomics.

The Quality Management System continues to follow a well-trodden path:

1.       Determine the needs

2.       Provide the system and tools required to meet the needs

3.       Ensure that the systems and tools are monitored and maintained

4.       Maintain objective evidence of how you have met the requirements

That’s Clause 6. Stay tuned for Clause 7: Product Realization.  This one is quite meaty, so we’ll take it in small bites!

And remember, you don’t have to deal with QMS alone. We can help with your assessment, auditing and training needs.

Give us a call at 508-641-5930 or complete the Contact Form to start the ball rolling.

Regards,

DonnaLynn

ISO 9001:2008 Clause 6 (Part 1) Human Resources

ISO9001:2008 requires that the organization “determine and provide the resources needed to implement and maintain the Quality Management System and continually improve its effectiveness, and enhance customer satisfaction by meeting customer requirements”  Ensuring the availability of resources is a key part of Management Responsibility.  Clause 6 breaks resources into three sections:

• ·        People
• ·        Facilities
• ·        Information Infrastructure

In today’s post, we’ll talk about people. As we run through an example, think of what you need for your business.

The intent of the clause is to ensure that anyone doing work, directly or indirectly, that affects conformity to product requirements must be competent.

To meet this requirement, you must:

1.      Determine the necessary competence

2.      Either hire people with this competence or provide training

3.      Evaluate the effectiveness of the actions taken

4.      Ensure that everyone understands the importance of their jobs and how they contribute to the quality objectives (The setting of quality objectives is another part of Management Responsibility)

5.      Keep records of education, training, skills and experience

Let’s work through an example:

John Frace has an auto repair shop.  What human resources does he need?

After meeting with the entire crew, John came up with key jobs for the shop.  Here’s a partial list:

• ·        Car Repair
• ·        Scheduling
• ·        Billing
• ·        Purchasing
• ·        Environmental and Safety compliance
• ·        Quality Management

He then determined the competence needed and how he would ensure that competence. A portion is shown below.

Next time, we’ll tackle the facilities and infrastructure requirements of Clause 6. Building and maintaining a practical QMS can be daunting.  We can help with your assessment, auditing and training needs.  Give us a call at 508-641-5930 or complete the Contact Form to start the ball rolling.

Regards,

DonnaLynn

ISO 9001 Engine

The ISO 9001 Engine……………..Management Responsibility

One thing that all businesses have in common in management.  Management directs and drives the 5 person service provider and the 50,000 person manufacturer. 

ISO 9001 recognizes the importance of management and devotes an entire clause to it.  As usual, it is all common sense.   Common sense with objective evidence……..

Here are the five specific actions the standard requires:

1.       Communicate the importance of meeting customer as well as statutory and regulatory requirements

While this may seem to be something that every employee should know without being told, it is critical that management emphasize that this is the foundation of doing business.  It is far too easy to let the minutia of the day to overshadow the customer, statutory and regulatory requirements.  People simply forget.

2.       Establish a Quality Policy

The Quality Policy provides the framework for the QMS and Quality objectives.  It must include a commitment to comply with and continually improve the Quality Management System. 

Don’t carve the policy in stone!  It is a living document that must be reviewed and updated in light of current business and customer needs.

Ensure that everyone in the organization knows and understands the policy and the importance of it.  Each person should be able to paraphrase it.

The Quality Policy keeps you grounded in reality.  Refer to it often.

3.       Establish Quality Objectives

What gets measured, gets done. 

You get to choose the objectives, but they must me measurable and consistent with the Quality Policy.

4.       Conduct Management Reviews

Management reviews provide a time to step back, assess and plan. The output of the review must include any decisions and actions related to the improvement of the QMS, product, or service per customer requirements and resource needs.

Small business owners often view this as overkill.  After all, they are hands on every day, why do they need to conduct formal reviews? 

That fact alone is a key reason to conduct the review:  take yourself from ground level to 50,000 feet so that you can see the interconnections and opportunities for improvement.

The reviews must include:

-       Audit results (not just that you conducted them)

-       Customer Feedback (not just complaints)

-       Process and product conformity

-       Status of Corrective and Preventive Actions

-       Follow up actions

-       Changes that could affect the QMS (this keeps the system and practice in sync)

-       Recommendations for improvement

5.       Ensure the availability of resources

Management has three additional duties:

1.       Define and communicate responsibilities and authorities.  People have to know what is required of them and who to go to for guidance and instruction.

2.       Assign a management representative. 

The management representative must be a member of management with the authority to ensure that the QMS processed are established, implemented and maintained.  In other words, this person keeps the QMS from simply being a book on the shelf.

The person must report the performance of the QMS to top management and ensure the promotion of the awareness of customer requirements.

3.       Ensure the existence and use of appropriate communication processes to broadcast the effectiveness of the QMS.

To go back to the engine analogy….

The definition of an engine is a machine with moving parts that converts power into motion.

Your company has many moving parts: people, information, infrastructure, machinery.  To convert these into the “motion” of profit requires good planning, good assessment, and good execution.  In short, it requires good management.

As always, please contact us for any of your Quality Management needs. We are ready to assist!

Regards,

DonnaLynn

Clause 4 ISO 9001:2008 Quality Management System

Clause 4 of ISO 9001:2008 requires you to “establish, document, implement and maintain a quality management system and continually improve its effectiveness”.

Good news: your business already has a system.!   You have processes.  Guaranteed.. You would not be in business without them.  Your current system may or may not exactly meet the standard.  It may or may not be exactly what you want.  But it is a starting place.

Now, back to the standard.

General requirements:  

First, determine your key processes and their interactions.  (A process is a series of action taken to achieve a particular end.)    Do a bit of brainstorming here.  Individuals will have different viewpoints.  You, as senior management will have the best overall view.  Be careful not to get caught up in the fine details.  Product design may be a key process, the test procedures are not.

Don’t just use words.  Draw a picture. Use lots of arrows to show connections.  Create a process flow.

 Here are some possible key processes:

Now you put the blocks in the order that reflects your business

OK, you have your key processes.  Now what?  How do you manage them?  How you know they are effective?  How do you know that you are successful?  A key element of this is to define what the output of the process.

Now, determine the inputs needed.  Determine the resources needed.  Determine how you will measure and monitor these systems to ensure success.

Anything reading as if it is from outer space?  I didn’t think so.  You know your business.  Now you are simply breaking it down into manageable, controllable steps.

By the way, any process that you outsource (an integral part of your process performed by an outside entity) must be controlled.  Manufacturers may send something out to be heat treated.  A service organization may outsource their call center. 

Documentation Requirements:

You must document everything you do in excruciating detail.  You should anticipate at least 20 volumes.

I am kidding.

Here, however, is what you do need:

ü  A quality policy

ü  Quality objectives

ü  A quality  manual

ü  The six required procedures

o   Control of documents

o   Control of records

o   Control of nonconforming product

o   Corrective action

o   Preventive action

o   Internal quality audits

ü  Documents, including records, determined by you to be necessary for the effective planning, operation and control of your processes

That’s if for today.  We’ll take a more in depth look at the documentation requirements in future blogs.

Remember:  The requirements of ISO 9001:2008 are simple and logical.  You get to decide how to best apply them for your business.  

As always, please contact us for help with any of your Quality Management needs.  We are ready to assist!

Regards,

DonnaLynn

 

So your customer is pressuring you to become registered to a Quality Management Standard

So your customer is pressuring you to become registered to a Quality Management Standard.  What a pain!  Just something to cost you more money and take your mind off the business.

Or is it? 

There is a reason why the ISO 9001 standard has for over  25 years and why over one millions companies are now registered.  Sector specific standards such as AS9100 for Aerospace, ISO/TS 16949 for Automotive and ISO 14000 for Environmental all build on ISO 9001.

The reason is common sense.  The reason is business/process management and improvement.    The ISO standard provides guidelines for good business/manufacturing practices.  Registration provides the verification that you have the systems in place.  Customers view it as verification that you have the systems in place and the discipline to maintain and improve them. 

The standard tells you the “what”; you provide the “how” that fits your business.

Good use of the standard leads to confidence and improvement.  Poor use of the standard leads to a waste of time and money.

So, while your customer may be “urging” you to seek registration, make it work for you. 

This series of articles will review each of the sections in detail, but let’s set the tone.

The eight principles of Quality Management ( ISO 9001:2008 subclause 0.1) are:

1.       Customer Focus

·         You must understand current and future customer needs in order to meet them.  Strive to exceed them

2.       Leadership

·         Establish and communicate the purpose and direction of the organization

3.       Involvement of people

·         Know, use and expand the talents of all people in your organization

4.       Process approach

·         Process: a set of activities that are interrelated or that
interact with one another.

5.       System approach to management

·         Manage the interrelated processes that drive the business.

6.       Continual improvement

·         Static companies don’t last.

7.       Fact based decision making

·         Ban knee jerk reactions. 

8.       Mutually beneficial supplier relationships.

·         Be a good customer to your suppliers.  It will pay off for both of you.

The words are nice.  The philosophy is logical.  The consistent practice requires thought, design and education.  The deployment requires discipline.

The rewards are tangible.

Start a conversation with your team.  How well do you practice the principles of Quality Management

Our next blog will discuss Clause 4 of ISO 9001:2008, Quality Management and General Documentation.

Please contact us for help with any of your  Quality Management needs.  We are ready to assist!

Regards,

DonnaLynn