Project Management

Please login or join to subscribe to this thread

Understanding Failure Analysis en Defects for Plastic Pharma

linkedin twitter facebook  
avatar
Eugene Jacquescoley DO PhD MPH Managing Partner | Eugene Jacquescoley Et Al Ptr Pa, United States
Hello. We've had issues with significant defects. We've determined that this an internal failure issue. Therefore, we examined our waste et rework procedures as it relates to assembly line of plastics. One of our researchers suggested that our failure analysis was not sufficient. How do we respond to this researcher? Secondly, how do we explain this to our stakeholders?
Sort By:
avatar
Keith Novak Tukwila, Wa, United States
I would ask the researcher to elaborate.

There are a lot of chemistry and engineering considerations in the manufacture of plastic parts. Defects can occur due to the selection of plastics, the quality control of the materials, the component design, the mold design, the molding process, etc.

Your researcher may believe you overlooked a critical part of the materials, design, or process as a root cause. At least hear what they have to add and whether they have a valid concern.

If you fully understand the root cause, it will be easier to explain to your stakeholders: You have a problem but you believe that based on your analysis you now understand it and have a solution in work. Better yet if you can put together a timeline for when you plan to verify your solution and incorporate the changes into production.

You will also maintain more credibility with your stakeholders if you get the solution right the first time instead of having to explain again later how you still haven't fixed it.
...
1 reply by Eugene Jacquescoley DO PhD MPH
Sep 04, 2022 7:59 AM
Eugene Jacquescoley DO PhD MPH
...
Keith,

I really appreciate your ok input. Particularly, est.root cause issues.

Thanks

J
avatar
Eugene Jacquescoley DO PhD MPH Managing Partner | Eugene Jacquescoley Et Al Ptr Pa, United States
Sep 03, 2022 3:28 PM
Replying to Keith Novak
...
I would ask the researcher to elaborate.

There are a lot of chemistry and engineering considerations in the manufacture of plastic parts. Defects can occur due to the selection of plastics, the quality control of the materials, the component design, the mold design, the molding process, etc.

Your researcher may believe you overlooked a critical part of the materials, design, or process as a root cause. At least hear what they have to add and whether they have a valid concern.

If you fully understand the root cause, it will be easier to explain to your stakeholders: You have a problem but you believe that based on your analysis you now understand it and have a solution in work. Better yet if you can put together a timeline for when you plan to verify your solution and incorporate the changes into production.

You will also maintain more credibility with your stakeholders if you get the solution right the first time instead of having to explain again later how you still haven't fixed it.
Keith,

I really appreciate your ok input. Particularly, est.root cause issues.

Thanks

J
avatar
Abolfazl Yousefi Darestani Manager, Quality and Continuous Improvement| Hörmann-TNR Industrial Doors Newmarket, Ontario, Canada
Is this a PM-related question? However, Keith made some good points.
...
1 reply by Eugene Jacquescoley DO PhD MPH
Sep 06, 2022 1:34 PM
Eugene Jacquescoley DO PhD MPH
...
Yes it es PM related. Refer to Risk Management guidelines en PMBOK.
avatar
Eugene Jacquescoley DO PhD MPH Managing Partner | Eugene Jacquescoley Et Al Ptr Pa, United States
Sep 06, 2022 9:12 AM
Replying to Abolfazl Yousefi Darestani
...
Is this a PM-related question? However, Keith made some good points.
Yes it es PM related. Refer to Risk Management guidelines en PMBOK.
avatar
Vijay Suryavanshi Project Manager - Engineering| RECARO Aircraft Seating Plantation, Fl, United States
Hi Eugene,

What kind of plastics do you make? Injection molded or vacuum formed plastics.

How did you determine that it is internal failure?

What products do you make assembling the plastics?

A failure analysis is a corrective action you do aftermath of the incident (When waste occurs?)

But may be the researcher is right?

My question to you is, " What preventive action are you taking to reduce the defects?"

Are you controlling the process (build of components or sourcing of components)?

Checking quality of components or plastics procured with a robust inbuilt process that tracks material confirmation and dimensional confirmatory (Coc and FAI is required?)

Are u using interchangeability and checking tolerances of the assembly during design phase?

These are some of the questions that you must ask yourself.

Also, to reduce defects statistically, using a Pareto diagram that indicates vital few defects of the trivial many is important. and among these vital defects you come up with a cause-and-effect diagram or fish bone diagram.

Suitable actions can be taken from fish bone diagram after knowing the causes like improving the process, quality check, design reviews, interchangeability of parts or check at assembly, building prototypes in a controlled manner etc.

To the stakeholder it is important that you show, you are not only taking corrective action but preventive action as well.

Hope this helps.

Please login or join to reply

Content ID:
ADVERTISEMENTS

"When one door closes another door opens; but we often look so long and so regretfully upon the closed door that we do not see the ones which open for us."

- Alexander Graham Bell

ADVERTISEMENT

Sponsors