If we are not meeting our Quality Objectives are we ready for ISO 9001?

[Tuuma]

We are currently in the process of certifying our QMS. The auditor company did a pre-audit prior to setting the certification audit date.

From the pre-audit we got a list of corrective actions and nonconformities that we need to address before the certification audit can take place.

Is this something that your certification auditor can offer?

 

[tammydiz]

Are you failing to reach ALL your objectives or just some of them ?

if you are failing to reach some objective the right thing to do is to investigate the root cause and take relevant corrective actions .

Furthermore are your objective S.M.A.R.T ? and more specifically "A" (achievable) ?

The trick with quality objectives is that they need to be neither too easy (which removes any challenge) nore too hard (which will never be achieved no matter how hard you try)

just my 2 cents

Can you give us an example of quality objectives you failed to reach , the previous data on which that objective wasbased on to be created , and the result you achieved ? what kind of corrective action was taken ?

Our bigggest objective is simply to be able to meet customer orders, which we cannot do. We are still trying to meet orders from last year and are behind on building product to meet the build goal for the month by almost 60%. We have not been able to keep our equipment running, therefore our downtime objective has been shot to heck and back. We have been down 30% of the month to date. Maintenance and contractors have increased their workload, hence overtime, so that budget is gone. We are expediting freight to our customers, when we have it available. We are having to re-work the product that comes off the line because it is not acceptable to customer specifications, which of course increases cost and lowers return.

Now...what have we done:

1. Hired more maintenance
2. Hired more contractors
3. Attempted to work with our customers and re-source their product from sister facilities and reduce expedited freight costs
4. Work with the OEM for equipment that does not meet expectations or fails (especially since some equipment still belongs to the OEM and has not been released).
5. Work the heck out of our employees when the line is running acceptably to get as much product out as possible (rotating shifts of course)
6. Implement a training system to ensure that all employees are trained to perform their jobs and are on the skill level they were hired for. This system also trains them how to perform basic maintenance on the equipment they run daily to assist maintenance and reduce workload and overtime.

 

[tammydiz]

Quote:
What accredited certification to ISO 9001 means
To achieve conforming products, the accredited certification process is expected to provide confidence that the organization has a quality management system that conforms to the applicable requirements of ISO 9001. In particular, it is to be expected that the organization:

*has established a quality management system that is suitable for its products and processes, and appropriate for its certification scope
*analyzes and understands customer needs and expectations, as well as the relevant statutory and regulatory requirements related to its products
*ensures that product characteristics have been specified in order to meet customer and statutory/regulatory requirements
*has determined and is managing the processes needed to achieve the expected outcomes (conforming products and enhanced customer satisfaction)
*has ensured the availability of resources necessary to support the operation and monitoring of these processes
*monitors and controls the defined product characteristics
*aims to prevent nonconformities, and has systematic improvement processes in place to:
1. Correct any nonconformities that do occur (including product nonconformities that are detected after delivery)
2. Analyze the cause of nonconformities and take corrective action to avoid their recurrence
3. Address customer complaints
*has implemented an effective internal audit and management review process
*is monitoring, measuring and continually improving the effectiveness of its quality management system

Do you think you could demonstrate such commitments in such a short time?

To answer your question...no I don't think I can - not with the current state of the facility. Especially when it comes to this point:
*has determined and is managing the processes needed to achieve the expected outcomes (conforming products and enhanced customer satisfaction)
Our process is managing us! Our product is not meeting customer requirements and our customers not not happy with us.

 

[Sardokar]

Our bigggest objective is simply to be able to meet customer orders, which we cannot do. We are still trying to meet orders from last year and are behind on building product to meet the build goal for the month by almost 60%. We have not been able to keep our equipment running, therefore our downtime objective has been shot to heck and back. We have been down 30% of the month to date. Maintenance and contractors have increased their workload, hence overtime, so that budget is gone. We are expediting freight to our customers, when we have it available. We are having to re-work the product that comes off the line because it is not acceptable to customer specifications, which of course increases cost and lowers return.

Hmmm...

2 things come to mind :

Point 1

- is your objective literally "be able to meet customer orders" or is there more to it ? because it doesnt seem very S.M.A.R.T to me

espescially given all the problems you are describing .

How is this objective measured ? what is the exact KPI ? what is the target ? what is the time frame ? how was this objective set (based on what ??)

looks to me like you are trying to reach the moon before having built a rocket

why dont you go at it step by step ...

like for example : be able to meet 40%,50%,60% (whatever) of customer orders on time .. and improve from there ?


Point 2 :

Now...what have we done:

1. Hired more maintenance
2. Hired more contractors
3. Attempted to work with our customers and re-source their product from sister facilities and reduce expedited freight costs
4. Work with the OEM for equipment that does not meet expectations or fails (especially since some equipment still belongs to the OEM and has not been released).
5. Work the heck out of our employees when the line is running acceptably to get as much product out as possible (rotating shifts of course)
6. Implement a training system to ensure that all employees are trained to perform their jobs and are on the skill level they were hired for. This system also trains them how to perform basic maintenance on the equipment they run daily to assist maintenance and reduce workload and overtime.

None of the above measures are corrective actions (except maybe point 6 ,if root cause was a training problem)

but the first 5 measures are corrections , not corrective actions

did you try to find the root cause of why "We have not been able to keep our equipment running, therefore our downtime objective has been shot to heck and back. We have been down 30% of the month to date" ???

by finding out the root cause of your equipment failure and FIXING that root cause you will have implemented a corrective action and prevented downtime from re-occuring .

If you just are Hiring moreemployees and making them work overtime it will not fix things by itself im afraid

you need to implement more corrective actions iMHO .

 

[tammydiz]

We are currently in the process of certifying our QMS. The auditor company did a pre-audit prior to setting the certification audit date.

From the pre-audit we got a list of corrective actions and nonconformities that we need to address before the certification audit can take place.

Is this something that your certification auditor can offer?

A pre-audit is not in our contract and management did not want one.

 

[tammydiz]

Hmmm...

2 things come to mind :

Point 1

- is your objective literally "be able to meet customer orders" or is there more to it ? because it doesnt seem very S.M.A.R.T to me

espescially given all the problems you are describing .

How is this objective measured ? what is the exact KPI ? what is the target ? what is the time frame ? how was this objective set (based on what ??)

looks to me like you are trying to reach the moon before having built a rocket

why dont you go at it step by step ...

like for example : be able to meet 40%,50%,60% (whatever) of customer orders on time .. and improve from there ?


Point 2 :



None of the above measures are corrective actions (except maybe point 6 ,if root cause was a training problem)

but the first 5 measures are corrections , not corrective actions

did you try to find the root cause of why "We have not been able to keep our equipment running, therefore our downtime objective has been shot to heck and back. We have been down 30% of the month to date" ???

by finding out the root cause of your equipment failure and FIXING that root cause you will have implemented a corrective action and prevented downtime from re-occuring .

If you just are Hiring moreemployees and making them work overtime it will not fix things by itself im afraid

you need to implement more corrective actions iMHO .

Exactly...which is why we aren't ready. As I stated I have written the procedure for corrective actions and created the forms, but it has not been implemented. Management does not understand the benefits of this process and root cause analysis. They are of the mind set that they will just bring in engineers from our sister facilities and the OEM and everything will work out.

That's what I need to convey to management from my original statement - we are not ready. But how can I get the point across effectively to them from an ISO standpoint?

I do like the point from Sidney Vianna which included the document on What accredited certification to ISO 9001 means. That may assist me.

I personally know we need to implement CA/PA and other processes, we need to have supporting data, we need to control our processes and keep our customers happy, etc. I think managment understands this , but they think if we have the documents in place and go through some of the motions it will be enough. I'm sorry, but I don't just want a piece of paper on the wall, that piece of paper means something to me. It means that as a company we have worked hard to implement (with supporting data) and maintain an effective QMS that not only meets the ISO requirments, but keeps our customers happy, sustains our workforce and stakeholders, achieves the goals that we have set and enables a positive outlook for our future. I guess I'm being dreamy again...

 

[Brunetta]

Tell your management that they will not get the certificate for their wall and will incur additional expense from their CB. (For example, a major nonconformity will require our CB to come back out and re-audit the area within 90 days to ensure the corrective action is effective - this costs money)
Review your contract with the CB and see what the impact of a (or many) major nonconformity(ies) would be in monetary terms and deliver that report to your management.
This should get their attention.

 

[jasonb067]

Brunetta is correct.

I would simply lay out the facts as they are to Management.

If we have an audit based on the current plan we will not get certified because of A, B and C ...

Not only that but we will then have to accomplish corrective action to those issues within time frame described by CB and it will cost us more.

Just plain give the facts. Do not over state the facts do not be a dooms dayer just state the facts. When the facts have been stated ask, "would you like me to schedule the external audit as was first scheduled"?

That is what I think your role in this situation is.

 

[tammydiz]

Tell your management that they will not get the certificate for their wall and will incur additional expense from their CB. (For example, a major nonconformity will require our CB to come back out and re-audit the area within 90 days to ensure the corrective action is effective - this costs money)
Review your contract with the CB and see what the impact of a (or many) major nonconformity(ies) would be in monetary terms and deliver that report to your management.
This should get their attention.

I like that perspective!

 

[tammydiz]

Brunetta is correct.

I would simply lay out the facts as they are to Management.

If we have an audit based on the current plan we will not get certified because of A, B and C ...

Not only that but we will then have to accomplish corrective action to those issues within time frame described by CB and it will cost us more.

Just plain give the facts. Do not over state the facts do not be a dooms dayer just state the facts. When the facts have been stated ask, "would you like me to schedule the external audit as was first scheduled"?

That is what I think your role in this situation is.

When the facts have been stated ask, "would you like me to schedule the external audit as was first scheduled"?

That is what I think your role in this situation is.

I think there may be light at the end of the tunnel. I'm trying to be all "ISO requires this and that" and "we need to show/accomplish this or that". Perhaps laying it out as stated will actually work!