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Quality Management

Is anybody interested in a set of quality management modules that would assist in ISO, FDA and/or CE certification? Some examples of modules would be:

Document Control
Process Control
Specification Control
Item Inspection Plans
Inspection Data Collection
Nonconformance Records
Corrective Action Records
Engineering Change Control
Preventative Maintenance Records

We probably are. However, I think the best approach may be to just adapt
or integrate existing tools.

Example 1: we use TWiki for Document / Process / Specification Control, etc.

Example 2: we use Mantis for Nonconformance / Correct Action Records and
for Engineering Change Control

I doubt OpenMFG will ever be able to match their functionality. In
addition, having the information Web accessible (TWiki, Mantis) is easier
than logging into OpenMFG and can make the data accessible to vendors,
customers, etc.

On Thu, July 13, 2006 9:23 am, marena wrote:

Is anybody interested in a set of quality management modules that would
assist in ISO, FDA and/or CE certification? Some examples of modules
would be:

Document Control
Process Control
Specification Control
Item Inspection Plans
Inspection Data Collection
Nonconformance Records
Corrective Action Records
Engineering Change Control
Preventative Maintenance Records

Tom, I’d be interested in hearing more about how you’re using Mantis for ECC. Assuming we can navigate any licensing issues, we’re very likely going to build the Incident Management functionality in the CRM module in a way that Mantis could front-end into the system.

Regards,
Ned

Tom Anderson wrote:

We probably are. However, I think the best approach may be to just adapt
or integrate existing tools.

Example 1: we use TWiki for Document / Process / Specification Control, etc.

Example 2: we use Mantis for Nonconformance / Correct Action Records and
for Engineering Change Control

I doubt OpenMFG will ever be able to match their functionality. In
addition, having the information Web accessible (TWiki, Mantis) is easier
than logging into OpenMFG and can make the data accessible to vendors,
customers, etc.

On Thu, July 13, 2006 9:23 am, marena wrote:

Is anybody interested in a set of quality management modules that would
assist in ISO, FDA and/or CE certification? Some examples of modules
would be:

Document Control
Process Control
Specification Control
Item Inspection Plans
Inspection Data Collection
Nonconformance Records
Corrective Action Records
Engineering Change Control
Preventative Maintenance Records


Ned Lilly
President and CEO
OpenMFG, LLC
119 West York Street
Norfolk, VA 23510
tel. 757.461.3022 x101
email: ned@openmfg.com
www.openmfg.com

Ned, we just treat the “engineering change” as a “bug”. We are a
smaller company so we don’t have layers of approval but Mantis is
flexible enough to address layers of approval also although an
administrator may be required to monitor things if things get too complex.

We have another program going on where we use Mantis as the
“complaint” or “enhancement request” mechanism for improving the
product. It works well. It allows anonymous (non-user) entries also.

For the ECC, we had custom fields of:

Category: BOM, ITM, Routing, Drawing, etc.
Change Type: Class I or Class II
Customer Approval Required?
Non-Conformance Reference (if any)

At 7/13/2006 10:02 AM, Ned Lilly wrote:

Tom, I’d be interested in hearing more about how you’re using Mantis
for ECC. Assuming we can navigate any licensing issues, we’re very
likely going to build the Incident Management functionality in the
CRM module in a way that Mantis could front-end into the system.

Regards,
Ned

Tom Anderson wrote:

We probably are. However, I think the best approach may be to just adapt
or integrate existing tools.
Example 1: we use TWiki for Document / Process / Specification Control, etc.
Example 2: we use Mantis for Nonconformance / Correct Action Records and
for Engineering Change Control
I doubt OpenMFG will ever be able to match their functionality. In
addition, having the information Web accessible (TWiki, Mantis) is easier
than logging into OpenMFG and can make the data accessible to vendors,
customers, etc.

On Thu, July 13, 2006 9:23 am, marena wrote:

Is anybody interested in a set of quality management modules that would
assist in ISO, FDA and/or CE certification? Some examples of modules
would be:

Document Control
Process Control
Specification Control
Item Inspection Plans
Inspection Data Collection
Nonconformance Records
Corrective Action Records
Engineering Change Control
Preventative Maintenance Records


Ned Lilly
President and CEO
OpenMFG, LLC
119 West York Street
Norfolk, VA 23510
tel. 757.461.3022 x101
email: ned@openmfg.com
www.openmfg.com

We are a small Medical Device company, approved FDA, ISO, CE.

I am kooking for a Quality Management sys which will allow us to use xTuple by our company.

I am interested in seeing a demo of Manufacturing sys.

Please advise.

Regards,

Yona

Please advise when the Quality Management feature will be available.

Please advise regarding compatibility to ISO, CE & FDA.

Please advise how I can have a Manufacturing demo for evaluation.

Thanks,

Yona Katz

Vice President, Operations

VisionCare Ophthalmic Technologies, Ltd.

Office +972 3 9284003; Mobile +972 52 840 3524 ; Fax +972 3 9225464; www.visioncareinc.net

We've made some progress on the QC system. You can view a recent draft specification here: http://www.xtuple.org/specificiations/quality-management-system

We are currently looking for sponsors for this project. If you would like to get involved, please contact sales@xtuple.com