Hello Everyone

First of all, i thank everyone in the forum, for making such lively, knowledgable & informative discussions on Quality.

I should appologize first, for packing a large set of questions in a single thread.

To my Question:
1. We sell Class I devices. I understand that we are a Specification Developer - as we designed & developed the device - and we have the contracted the manufacturing to a contractor, for entire finished device, along with shipment and repair. Since i started just a few weeks ago, i am making a present stand analysis of our processes for regulatory complaince, as we wud like to improve our processes.

I would appreciate your help and explanation on which sections of QSR apply to the SPEC Developer (us) and those sections that apply to our Contract manufacturer. QSR manual introduction just quotes, that "Contract manufacturers and specification developers shall comply with the sections of the QS regulation that apply to the functions they perform."


2.On issues of our purchasing and logistik functions - what are the parameters and inputs that have to be considered in writing a procedure or SOP for our Purchase function, for this type of business. I should make a note that we already ve SOPs & WIs, regarding component procurements, for certain other devices that we manufacture.

Would it possible for any of you to guide me with an SOP that a Purchasing fucntion of SPEC developer shoud have and how it shud look like, how the process should look, with what the inputs and outputs are.

3.What are the controls that we need to make on our contractor, espcially with regards to documents that need to approved or released by us, as well the engineers at our contract manufacturer.

4.As i heard from our developers, the service manual for the device is created by us without cooperation from our contractor, though the repair is done by our contractor, would it be a violation of regulations, b'cos the engineers at our contractors claim, that they are well versed with the device, that they ve established their own procedure.

5.What docs of DMR, should be controlled by us & what docs have to be controlled by our contractor.

6.Release documents for Production process and Finished Device Accepatance procedure is created by our contractor and signed by their engineers, where in we just get a copy. Is it a violation of regulation?

6.what docuemnts constitute Distribution records that our contractor shud hold and which docs we shud hold?

7. What are the functions and documents that both of us should work together, for release?

I understand that most questions that i have asked look comprehensive and it requires a lot of patience to answer, therefore i am greatly thankful to all of you, having spent time looking at these questions.

Anyone want to give it a try?

Krishna, are you attempting to establish a QMS system? Is that where a large part of your questions are coming from?

Hi Krishna

There is little difference between a Specification Developer and a manufacturer. It is just that rather than a manufacturer working with a few minor contractors, there is now one major contractor. The procedures are the same as if you were a full manufacturer, but the relationship with the contractor pushes them to the extreme. As a Spec Devemoper, you have to control the contractor much more carefully.

I would start with a good, thorough Quality Plan or Service Level Agreement, defining who is responsible for what aspect. As long as someone is taking responsibility and the decisions are well documented, FDA should be happy.

As part of routine audits of the contractor, I would "approve" their procedures as being suitable for manufacturing the device and check that your specifications are being implemented correctly. Again, it is all routine supplier approval/control procedures, but taken to a higher level.

The DMR is a mix of Design specifications and manufacturing procedures. As such, it is probably easient to issue a Technical File of specifications to the contractor and let him add the manufacturing procedures to make a complete DMR. You need to make certain this is tied down in your procedures and that the contractor really can control external documentation.

Make certain finished goods inspection procedures are well documented. These should be your procedures and appear in your Technical Files.

One thing you did not mention is complaint handling. I would strongly suggest you do this yourself. You know the device and the market place. You are also responsible for MDR handling, so you need to know that the complaints are being dealt with properly.

At the end of the day, your company has all the responsibilities of the "Manufacturer" and are responsible for complying will all aspects of the QSR. Where you identify that the contractor is doing the work for you, you have to confirm that it is being done properly.

Hope this makes some sense.

Thanks to both Brad & Chris on discussing this Topic:

First to Brad,In a Sense it is review of our QMS, though we ve one. we are new to this instruments business, as we ve some other product, that we do our own manufacturing/production. Here we want to make sure that we ve processes that can apply to this new business and we are running it properly & we wont be an outcast in a FDA audit.

And Chris, Thanks for the elaborations on Contractor - Legal Manuf relations. Certainly we ve made a contract & till now everything is working fine, as i came out of analysis, we make the docs, so do our contractors, but as see it, not everything is formal or some of them are not written in procedures.

For e.g. in release of design transer, its just our developers, who ve signed for the release, as i understand, design transfer is that stage, where manuf proces also plays a important role & i believe we should ve written procedures on joint consultation & release with out contractors. Similarly, our contractors have a manufaturing process & subsequent releases, that just send us a doc for Info & where i beleive we need to formally sign it. So as i sees these are some Gaps, where we need to curb it for future deals.

The 2nd thing is the role of Purchasing manager or Purchasing process in general, as they are the ones who place the order on the contractor as per sales forecast. So i see we need to redifne and write a proc, that should address control over contractors, and it should be different from normal component procurement model, as we do it generally for the products we ve inhouse production.

Indeed i would be greatly interested to know what and where are the controls we need to put on contractors and what docs are to delegated, like what we should hold, what they hold and what both of us should share (formally) - these docs important for DHF, DMR, DHR?. Do you think i might find any checklist on this.

Are there any recommendations on this?

Hi

Design Transfer will be difficult, you will probably need to perform this internally first, then prove that the device your contractor makes is the same as the one you finalised. However this is largely a matter of verifying that the finished product still meets the design specifications. I dont think you need to worry about the contractor's design procedures, as long as their output matches your inputs.

I'm not sure why purchasing needs to be more complicated than normal. You need to ensure that the POs reference all relevant specifications, technical agreements, standards, etc.

As to who keeps which documents, this is probably a matter of convenience. The company who has to make the most frequent updates, probably should control the document. Just make sure that if the contractor is holding them, they really are controlled and being used.

Hi there Krishna, I work for a medical device company in the UK and we also utilise OEM manufacturers. We gave them a full set of SOP's, WI's drawings, forms etc. In fact we gave them every piece of paperwork we had in order for them to manufacture our product. We had to change some of the workings of the procedures for their benefit and working practices. We audit them every 6 months which takes two days to do and ensure that they are in continual compliance with our procedures etc. We govern the procedural changes also, so basically we do all the documentation and they do all the manufacture in accordance with the paperwork. We also control the suppliers for components of our product even though it is the OEM company that places the orders etc. Its hard work controlling another company this way, but at least you can be sure that they are producing on a constistant basis, your product the way that you want it making. HOpe this helps.:agree:

Hi Welshery

Thanks for the reply, i agree with you that by providing your procedural docs, you place control over them. But my question arises here; should nt both the SPEC developer and contractor have joint responsibility to control such documents and also later during the manufacture or design transfer, should nt they sign the release docs jointly?...

But one aspect that i should reinstate and which you have rightly pointed out is the audit of the contractor, which we have not conducted and for which dont have any procedure - as i am trying to understand what difference does it quote, when it comes to audit (and also assessment) a supplier for normal component procurement for in-house manufacturing and audit of a contractor who manufactures the entire device?

Hi there again. We developed our work instructions (WI's)jointly with the OEM company. Its no good just writing procedures and work instructions if they cant be implemented into someone elses working practices. So we jointly prepared the WI's with the OEM company and they also signed them off under the approval section. This then showed that they had agreed to work in accordance with the documented requirements, thus they couldnt come back at any stage and say they either didnt understand them or couldnt work to them. The OEM cannot change any documents, that has to be done by us, but they can put a "proposed document change" form through to us for review and if we feel it should be implemented then we perform a document change through our procedures. We never allow them to do the change, no matter how small it may be and again we jointly sign the approval sections. When we audit suppliers of materials etc, we follow the supplier audit procedure, but we have adapted it for OEM manufacturers to include technical dossier/manufacturing requirements,, SOP's, ISO etc., exactly the same as if we were auditing our own manufacturing facility. We have developed a specific auditing procedure for our OEM. Its double the work, obviously for our auditors because not only do they perform full manufacturing audits at our site, they also do the same at the OEM site but over a very intense two day audit. If we find any non-compliances we then expect the OEM to follow these up as part of their own internal audit schedule and we expect weekly updates on their progress, again they have already agreed and signed to this in a procedure/agreement. I suppose also it depends how critical the product is, we are making a Grade III critical device (implanted into the human chest) so we have to make absolutely sure that what our OEM does is in line with what we do ourselves and we are very strict about this. I am not sure if you need to be as strict with other devices. It is best to be safe and I always say that if you cant do it yourself, then make sure others do it your way...... quality is paramount especially in medical devices.

I hope this helps a little more. :agree1:

Hi Welshery

Thanks for the explanation. Let me propose necessary measures and proposals to our management, and then let me evaluate how it runs. May be i would be turning up now and then, for small suggestions.

Thanks to everyone, who ve taken part in this post.

Hi. I was a level II certified international medical device investigator for the FDA for over 21 years, and am now a contract international medical device consultant for hire.

First, are the medical devices going to be sold in the US? If so, the US classification scheme is different than the European classification scheme. For example, class I medical devices (such as bandages or canes) are the least risky devices health and safety wise and do not have to undergo as stringent controls as other devices (such as class II/III pacemakers, implants, or monitors).

If the product is a FDA class I device (unless exempt from 510(k) filing), then your firm will have to follow 21 CFR 820- QSR. If it is a FDA class I exempt product, then you will only have to deal with the document control and complaint sections of the QSR + 21 CFR 803 (MDR's).

To answer your questions, assuming you will be marketing class II/III products in the US:

1. A specification developer is responsible for product specifications and complaint handling. This means, if you have another company manufacture the product for you, they have to follow your specifications. If you are not familiar with the manufacturing process, leave it up to this other firm. However, you have to review and approve each batch record before final release and are responsible to make sure they are compliant with 21 CFR 820. You are also responsible for purchasing controls re this firm as well.

As a spec developer, you are also responsible for:
1. Management controls.
2. Design controls.
3. CAPA.
4. Production.
5. Records/documents and change control.
6. Facility and equipment control.
7. Material control.

no matter where certain operations are conducted.

Of course, if you have a contract with the manufacturing site, some of these operations may be the responsibility of the other firm, but you have to make sure the other firm is in compliance by having proper purchasing control operations in place.

2. Regarding purchasing controls, you first have to figure out how you want to approve your suppliers, contractors, and consultants before any procedure can be written. You can use information contained in various FDA and Global harmonization task force guidance documents as an aid.

3. As far as controls are concerned, you have to determine who will be responsible for the various functions (as I noted above). This will of course have to be spelled out in a contract. Ultimately, you are responsible to make sure that good product goes out the door and bad product stays inside.

4. The service manual is labeling and a design control output (assuming the product is not a FDA class I product). As specification developer, you are responsible for design controls. Again, this function may be contracted out, but your firm is responsible for the product design.

5. Again, with DMR's and DHR's, they have to be onsite at the manufacturing firm(s), but copies have to be supplied to you, since you are the specification developer. You should review them to make sure they are manufacturing your product per your specification. If acceptable, you should sign and date the approved DMR's.

If more than one firm is conducting operations (such as firm A conducting manufacturing operations, firm B conducting testing operations, and firm C conducting sterilization operations), you have to have copies of the complete DHR's and sign off on the total DHR, because you are responsible for the device, not these contract sites.

6. No it is not a violation to have copies, because FDA may be visiting your site as well as the other sites at the same time. But remember, you have ultimate responsibility. This is why all operations, including recordkeeping and handling should be addressed in contract form.

7. Again, this depends upon who is conducting the distribution operations. You as spec developer have to approve all DHR's before any batches can be released for sale (even if these batches are distributed by another firm).

8. You as spec developer have to make sure that the product release specifications meet your specifications. Again, if the product undergoes design control operations, then you have to make sure that essential outputs are transferred into the production DMR's and incorporated into the DHR's.