IQ/OQ/PQ in a Tool Shop with a Small Injection Molding Plant

E

Ellie May

#1
I work for a tool shop with a small injection molding plant included. We make electronic connectors and some of them may be used for medical applications. We may have to start an IQ/OQ/PQ protocol, and I do not know how to include this into the quoting of the tool, or the molding sampling. If you have any suggestions please let me know. We may or may not end up running the production, most of what we do is just sample and measure the final product. How much of the IQ/OQ/PQ will we be responsible for.:confused:

Thank you for any help you may be able to give!
 
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Kevin Mader

One of THE Original Covers!
Staff member
Admin
#2
Re: IQ/OQ/PQ help!

Ellie May,

You may want to enquire as to who will be responsible for developing the requirements and the associated validation documents. If your customer recognizes that you are a smaller organization, then they may elect to support this activity internally. For instance, I will utilize a Process Control Engineer of mine to support this type of activity for a smaller supplier of our provided they are a strategic supplier. In addition, my colleague in Operations would need to loan resources as well, generally in the capacity of Test and Process Engineers. Validation is generally a costly activity, but the advantage here is that inspection requirements generally are reduced (essentially, the upfront investment offsets the downstream inspection activities). Additionally, it is a regulatory requirement for your customer, so dependent on where they achieve the assessment, it may in fact have to be done at your location. You may also look into the cost of a temp resource to perform these activities. Expect to pay somewhere between $75-150 an hour for a good validation engineer with project management skills. There is a ton to consider here, so unless you have expertise in this area, outsourcing is the way to go. You can, however, offset costs by providing your internal support under their/the hired resources guidance.

Regards,

Kevin
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Kevin gives some excellent advice about utilizing the customer's resources if they have them. In my experience most fair sized companies do have people that can help. I did blow molding and injection molding with a large consumer goods company and they had someone to hold my hand all the way through their IQ/OQ/PQ process the first time around. As did other companies I worked with.
That would be my first choice.
Second would be - does the business warrant a QA Engineer full time? Will there be more business along the same lines to help justify this?
Third would be the outsourcing option.

It's been a while but here's what I remember in a nutshell of our IQ/OQ/PQ process for amentiy size bottles:
IQ - Initial mold and tooling check out. Checklists of parts, fittings, etc. Do they all fit together in the machine. Heat it up and shoot some plastic until you have parts. Check parts for all cavities - full dimensionals.
OQ - 8 hour run in production once the process is brought to stability with all settings locked in. Pull samples one from each cavity every 30 minutes. After sitting for 24 hours do critical dimensions on the 1st, middle, last samples and crunch stats. Do physical testing on samples between 1st and middle, middle and last.
PQ - this was based on 3 production runs of SPC data and how the parts ran at the filler.

Keep in mind this isn't a medical device. It was for hair care products, but it was in molding so it might give you a general idea.

I've also done the process for filling drug product. The data was different and included cleaning/sanitizing validation, but the core process was the same.
 
E

Ellie May

#5
Thank you very much guys. You did simplify the process a lot Scott. We are still in the phase of learning what all is involved in this IQ OQ PQ and are not even sure if it would be cost effective for us to move forward. It does seem that a lot more of our potential customers are requesting this in our quotes. We have no clue how to quote the cost for new tools if we need to use IQ OQ PQ. Most of the tools we build we only sample, this makes it difficult to determine the necessity of such a program. We do have a full time Quality Engineer who is working with me and researching more information. I have a sample IQ and OQ for another injection molding company so the process of validation has been explained. Our dilemma is whether it would be cost effective for us being such a small company. We do run production for some customers, and implementing this may bring our molding department more jobs, but how do we determine if we should mover forward.::bigwave:
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
Thank you very much guys. You did simplify the process a lot Scott. We are still in the phase of learning what all is involved in this IQ OQ PQ and are not even sure if it would be cost effective for us to move forward. It does seem that a lot more of our potential customers are requesting this in our quotes. We have no clue how to quote the cost for new tools if we need to use IQ OQ PQ. Most of the tools we build we only sample, this makes it difficult to determine the necessity of such a program. We do have a full time Quality Engineer who is working with me and researching more information. I have a sample IQ and OQ for another injection molding company so the process of validation has been explained. Our dilemma is whether it would be cost effective for us being such a small company. We do run production for some customers, and implementing this may bring our molding department more jobs, but how do we determine if we should mover forward.::bigwave:

What do you mean as a sample? Like a prototype?
You shouldn't have to validate a prototype tool. Only the actual production tool that's going to produce finished goods should be validated.
Also - are you selling the tooling or are you going to mold the parts too?
If you're selling the tooling your part really ends after the molder's IQ phase. And even then - you're only responsible for the tooling itself, not the press.
 
E

Ellie May

#7
Good point, some of the work we do is prototype. But wouldn't we still be responsible for the IQ part, since we run the samples in house? We are responsible for all the measurement data at the time of the sample also. Some of the molds we build we do run production and some we don't. This is something we clarify with our customers prior to the build. And how do we determine the cost of implementing IQ OQ PQ in the initial tooling quote.
 

yodon

Staff member
Super Moderator
#8
Sounds to me like you're a contract manufacturing shop. If that's the case, the impetus to validate the processes and equipment is not yours, it's the company contracting you to do the work. Further, it sounds like you're only supplying components, not finished goods. The 'manufacturer of record' would need to determine how they accept your parts. This could be 100% test / inspection - in which case the processes / equipment creating the component would not require validation.

If I'm close, I don't think you would be responsible for any of the validation UNLESS you are commissioned to do just that; i.e., not on your dime. I would agree with Kevin that if you want to quote the service as part of the tooling, then you should probably get a consultant to help.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#9
Good input folks!

In my experience, few smaller contract manufacturers/suppliers have the understanding and the resources to execute an IQ/OQ/PQ. However, I recognize that if one were to have the capability, it would get my attention.

While driving home tonight, I was thinking about something an ex-FDA agent told me. It was his belief that Process Control at a supplier did more for a manufacturer than a Process Validation. Although the requirement is to periodically revisit validation, the reality is that it isn’t often done (except when the process changes significantly). Process Control is real time there for a better solution in his mind. He may have a point. Nonetheless, if the item you’re producing is a final product, Process Validation or Qualification might be mandatory. Look into your options.

As noted above, take a look at what FDA has to say on Process Validation. Also, read the Global Harmonization Task Forces Guidance on the Principles of Process Validation. You should find all you need to understand the concept well enough, however, the combination of good theory and experience (perhaps provided by a hired resource) yields the best results. Because this is generally an expensive process, going cheap usually results in poor results that aren’t worth much. For validations I have been a part of, costs ranged between $40K and $2M+. Recognizing the kind of investments possible, going short on a resource might prove to be a costly error. On a few occasions, costly validations had to be repeated because of poor preparation and inexperience. Luckily I worked with a company with deep pockets. Without that luxury, it is possible to sink a smaller organization.

It looks like you have some capable colleagues to glean information from. This looks like it might be a very productive thread.

Good input everyone!

Kevin
 
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