ISO 9001 QMS Implementation in an Engineer To Order business

[freddy_v]

Hello,

(I am in the beginning of this QMS implementation project, and I've noticed it's easy to fall into the pitfalls of detail. If this thread seems unstructured and confused - I apologize).

Background:

I'm just starting up a QMS implementation project with the primary goal of improving our business and the secondary goal of getting the QMS of our company certified according to ISO9001:2008 standard.

I've been a member of the cove only for a short time, but I'm already amazed about the extent of the knowledge that comes together here.

However, the context of this potential QMS is that its working in an engineer to order business. We make custom designed material handling tools for robots to fit and function in unique cells. We also make custom designed packaging (you know those shine-through PET boxes which holds earplugs or headphones etc.) Also, most projects have short lead times. I would say the average project is about six weeks.

Processes:

I'm currently mapping out the processes, to get a more detailed understanding of the inputs, outputs, controls and resources.

At a birds view we
1. Promote, develop and sell
2. Design
3. Purchase, produce and control

(The outputs up to this point is the components of the robot tool and the components for the packaging manufacturing line).

After this, the flows for the two different product branches separates into

4.1 Assemble, Test and Deliver (converging flow of material)
4.2 Produce the packaging, inspect and deliver (/store) (diverging flow of material).

As I suspected - at the more detailed levels

1. The product is a variable.
2. The processes are variables.
3. The resources are variables.
4. The controls are variables.
5. The scope of each project is a variable.

The only common denominator I find at this point, is the "structure" of the projects.

I find that this is prohibiting me from detailing the processes, except from a few important steps, and that I absolutely must leave gaps in the system to be filled by the implicit and explicit knowledge of the operators. Since the system in its current form (undocumented as it is), relies heavily on the skill of the workers, I suspect we must have some sort of control on the knowledge of the workers.

Questions (speculating about the QMS):

1. Our company uses on the job training to develop skillful workers, without exception. How do you document and evaluate training for this when you never know exactly what is demanded?

2. About corrective actions. Let's say a non-conforming product is spotted at some point in the flow. How do you capture this in the QMS without being to rigid? I.e Who should decide upon the corrective action?

I would really appreciate some input on this, or about implementing ISO 9001:2008 in a Engineer to Order (ETO) business in general (are there perhaps any literature regarding this subject?). Pehaps the "PMBOK" is something I should take a look at?

Thank you!

 

[somashekar]

Welcome to the Cove ... freddy_v

1. Our company uses on the job training to develop skillful workers, without exception. How do you document and evaluate training for this when you never know exactly what is demanded?

That covers pretty well for the workers in whom you build the needed skills. What is demanded is the skill and perhaps you are doing your bit to make a semi skilled worker skilled enough to your specific requirement. You can document it as individual training records, wherein various skills that are imparted are mentioned and your own scale of skill levels are said as met. Effectiveness comes from observation of workers demonstration, of both quantity and quality before and after imparting the training over certain time, and the responsible manager under whom the worker operates will be the key person to state effectiveness of training or need for re-training.
Training for the rest of the employees can be provided after a gap analysis of each employee about what you want against what he has.

2. About corrective actions. Let's say a non-conforming product is spotted at some point in the flow. How do you capture this in the QMS without being to rigid? I.e Who should decide upon the corrective action?

Capture it as soon as spotted. Correct and record. Analyse such records over certain time. What was the expected level ? Does the record show meeting or exceeding that level ? Keep monitoring
Any trend of increasing non conformance ? Analyse the records and decide what corrective action needs to be taken up. Root cause analysis and suitable actions and stuff. SPC can be useful here. Set your realistic limits. Once you set performance limits that are practical into your system, your system will decide the need for a corrective action.

ISO9001:2008 expects that you review nonconformities, determine the causes and evaluate the need to take actions, so that they do not recur.

I hope you can see what I mean.