ISO 9001 Vs. QS-9000 - Does ISO 9000 not require a Control Plan, FMEA, etc.?

[Rios oxnard qe]

I went from an QS9000 registered company to a profitable and well known Manufacturer which is ISO registered. I have encountered a lot of resistance to new methods, quality tool and controls that I would like to implement (CP and Flow Chart, FMEA, MSA (in house and supplier required),8D CAR Format). As a Quality Engineer, these tools realy helped me understand the process and make decisions.

Although, one tool that I realy believe we need and will try to fight this one tooth and nail, of course unless this forum convinces me otherwise, is a Control Plan.

We do not use a Control Plan nor do we request this from our suppliers as a requirement. It will help to verify Corrective Action implementation from suppliers, in house production controls and many other benefits.

I tend to still use the AIAG QS9000 Quality Sys. Requirement manual since it has a 'ISO Based Req.' section. According to this manual, element 4.2.3.7 states that "the supplier 'SHALL' develop Control Plans at the sys. ...level" and shows a Control Plan with the information required.

If a company is ISO registered or states that they are ISO compliant shouldn't they have some type of Control Plan? Maybe not necessarily in the QS9000 format but at least the information stated?

I would realy appreciate your input as it will help me decided if I need to step back and and/or go back to a QS9000 (TS16949) company. Thank you.

 

[Rachel]

If a company is ISO registered or states that they are ISO compliant shouldn't they have some type of Control Plan? Maybe not necessarily in the QS9000 format but at least the information stated?

Hello there,

The answer, I think, is this: you are not explicitly required to use control plans, FMEAs, or any particular tool of the sort. However, if your company does design and development, you are required to have quality plans...and these tools are commonly used as part of quality plans. My company uses the APQP process for quality planning - but things like FMEAs can also be considered as such.

You also are required to have control of your processes and production...again, these tools are not explicitly required, but they are smart tools to use in these cases and can get the job done in a concise and organized fashion.

Generally, the ISO 9K2K standard does not require you to use any one particular tool for any one particular task. 9K2K does list a bunch of requirements - things that you have to do - but does not specify how[\b] to go about doing these things. Keep in mind that you control your business...things that you do shouldn't be "because of ISO", but rather should be "because they're smart decisions for our company". ISO just gives you a framework...mould around it as you see fit.

Hope that helps. I don't blame you for wanting to push the issue with your company - the tools are useful. However, if your company already has something of its own developed, and if that system works for them, then maybe that's all you need.

Cheers,
-R.

 

[Howard Atkins]

I went from an QS9000 registered company to a profitable and well known Manufacturer which is ISO registered. I have encountered a lot of resistance to new methods, quality tool and controls that I would like to implement (CP and Flow Chart, FMEA, MSA (in house and supplier required),8D CAR Format). As a Quality Engineer, these tools realy helped me understand the process and make decisions.

Welcome to the forum.
The ISO9001 standard is so general and is for so many industries that there are no prest methods, each company develops the formats that are needed for it.
The methods probably exist but with a different name.

A word to the wise:
I do believe that any new person for his sake should learn the methods used before trying to change them.
There is always resistance to any change, be patient and after you have established yourself then gradually try to implement changes.

 

[Greg B]

Welcome to 9K2K

Rios,

Welcome to the cove and welcome to the quality brick wall. Many of us have been down the same road and unless management have been previously exposed to these tools and their benefits they tend to baulk at their introduction. Even if you get them implemented it may take many months even years before they become the norm and part of the company culture of improvement and understanding. You will have to prove the benefits to management. You must always remember the barriers to change and their remedies including the seven steps to change:
 Identify the problem,
 Establish desired outcomes,
 Analyse the problem,
 Generate alternative solutions,
 Evaluate alternatives and select the most suitable,
 Implement the decision,
 Follow Up and evaluate.
The culture of many companies is the major barrier to change and you have to find how they implement change. Talk to the Safety, HR and Environment people as they probably have had similar battles. Here is my slide show on culture, I call it Apes and Culture:
http://elsmar.com/Forums/attachment.php?attachmentid=709,

and the thread it camne from is called Teaching Quality!

http://elsmar.com/Forums/showpost.php?p=47217&postcount=1
Hope this helps

Greg B

 

[The Taz!]

Welcome to the Cove. . .wise words above.

If the company is very profitable as you stated, will these tools make a difference? Is the company out of control? Does it have any system to handle rejects? What are the hiring practices? What training were you given when you started? Do problems recur (i.e. not correcting root cause)? In short. . . what is missing in what they do?? Do they do the basics and just call them by a different name?

Profitability in this case can breed complacency which is a business sin and waste in itself in todays business environment.

Hershel has some wise words for you. . .we've all been there. . . the world does not move fast enought for a new QE who will or will not succeed based on his approach. Crosby wrote "Quality Is Free". . .he left off the "eventually" part.

All of the quality Tools you mentioned are very desireable. . . they work IF used right.

Take a deep breath. . . pick your battles carefully. . . and try to stay an arm's length away from the action at times. . . weigh what you are doing and always look for a positive (and profitable) impact. If the effort just costs money with no tangible payback. . . you're shoveling you-know-what against the tide.

What were you hired for? Do the job you were hired for and slowly, over time, you may have the impact you desire.

When something doesn't go right. . . YOU might just have the tool that makes it right again. Observe what the company does in various situations. . . and see if YOU could do it in a better way. . . . a different way may not be the best way.

 

[cncmarine]

All of the advice is very good.
Take some time and your tools will be used. I made the same jump that you did and has the same feelings.
Within a couple of months you will find that your in a perfect system.
ISO basics with the ability to use your QS 9000 quality any time that you want to.

 

[hank-qu]

We are using those quality tools such as FMEA, control plan ...though we are not a QS9000 certified company.

 

[The Taz!]

We are using those quality tools such as FMEA, control plan ...though we are not a QS9000 certified company.

Hi and welcome to the Cove. . .

I have a semi-related question for you. . . has your company seen a benefit from using the tools?

 

[sal881vw]

Welcome to the Cove. . .wise words above.

All of the quality Tools you mentioned are very desireable. . . they work IF used right.

Take a deep breath. . . pick your battles carefully. . . and try to stay an arm's length away from the action at times. . . weigh what you are doing and always look for a positive (and profitable) impact. If the effort just costs money with no tangible payback. . . you're shoveling you-know-what against the tide.

What were you hired for? Do the job you were hired for and slowly, over time, you may have the impact you desire.

When something doesn't go right. . . YOU might just have the tool that makes it right again. Observe what the company does in various situations. . . and see if YOU could do it in a better way. . . . a different way may not be the best way.

Hi rios & Taz,
If every I've seen a solid good advice, the above one is definetly it...well done Taz

 

[mooser]

Hi rios & Taz,
If every I've seen a solid good advice, the above one is definetly it...well done Taz

I couldn't agree more! I am experiencing the same thing trying to get certified to ISO and I too came from a QS backround. I am finding I need to pick my battles, show the company then that it can make money doing the way I suggest or some variation of my way that fits the present culture. You don't want to do it this way it gets us nothing but headaches all the time. You will have enough as it is.

Mooser