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Bringing Production In house

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#1
Working as QA RA lead on a project bringing our prod in house (ISO 13485 FDA Class II) from a contract manu. The lead engineer is insisting I determine what the requirements are for the machines and tool and the environment we use. I am stating that aside from ISO 14121 there are none. The requirements are the tools are safe/effective have been through V&V. The environment is not prescribed and just states we have to determine the env controls and implement and monitor them. Is this correct?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
Working as QA RA lead on a project bringing our prod in house (ISO 13485 FDA Class II) from a contract manu. The lead engineer is insisting I determine what the requirements are for the machines and tool and the environment we use. I am stating that aside from ISO 14121 there are none. The requirements are the tools are safe/effective have been through V&V. The environment is not prescribed and just states we have to determine the env controls and implement and monitor them. Is this correct?
These questions are a subset of what you need to look at when moving manufacturing in house, from a QA/RA (FDA & CE?) perspective.
I would take a more holistic approach to managing and addressing applicable requirements.
I sent you a PM some time ago - not sure you've seen it.
All the best,
Ronen.
 

somashekar

Staff member
Super Moderator
#4
Working as QA RA lead on a project bringing our prod in house (ISO 13485 FDA Class II) from a contract manu. The lead engineer is insisting I determine what the requirements are for the machines and tool and the environment we use. I am stating that aside from ISO 14121 there are none. The requirements are the tools are safe/effective have been through V&V. The environment is not prescribed and just states we have to determine the env controls and implement and monitor them. Is this correct?
Please tell that lead engineer that he at least maintains the same machines and tools and the environment as was approved at the CM.
If you are planning to get those same machines and tools from your CM ... OR you plan to buy the same type or better machines and tools., still you need to perform all your validations exercises (IQ/OQ/PQ) including operator qualification as your case needs.
About environment, if your device requirement does not need any special conditions to be created, and no such was also in place at the CM, your environment is ambient. But this needs a deeper levels of inputs and analysis considering your device and the locations of your CM and yourself.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#5
For IQ OQ PQ we plan on developing that for each internally developed and externally sourced tool. The overall implementation plan is much larger of course and this is a single action item.
 

yodon

Staff member
Super Moderator
#6
The point @Ronen E makes about a holistic assessment is likely what your lead engineer is asking about. Do you have adequate space for the equipment, are there new HVAC requirements as a result, does the equipment require special flooring, do you have sufficient utilities (power, air, water, etc.) to support the equipment, etc.

Realize also that the QMS is probably impacted - infrastructure and work environment.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#7
The QMS is absolutely impacted. We have performed a gap analysis and are working on the required documentation updates and risk analysis. I have internal (contracted) audits scheduled prior to production.

I am trying to state that the QA group doesn't drive the production method requirements - there are probably dozens of methods to execute our production; we are agnostic. Engineering does that work. Our process is very simple. It requires no more than 4 people start to finish and can be done around a picnic sized table - this is a Med Device startup with 15 employees living on investors funding. We want to demonstrate to our investors and new investors a more robust operation with production in house.

QA will be there to review and help develop plans to make sure requirements regarding floorspace, environmental controls, verification/validation, SOPs & Forms and other requirements. How we decide to build production is for us as a business to decide. I have to assure that whatever the method I can adjust it to meet the regulations we are required to meet.

My largest current concern is Im having trouble picturing the material movement workflow to prevent mix-ups. At other larger companies that segregation was simply required with the large inventory we managed. With a smaller operation creating that same spacial segregation is more challenging without having that much space.
 
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Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#8
Update: Making some progress. I created a "warehouse specification" to provide regulatory guidance on how ISO and QSR expect things to run. Should I entertain the idea of a "design review" of the floor layout to help catch issues before we have nearly completed the task of warehouse development? Does the "prevent mix up" clauses of QSR and ISO require any documentation?
 

Al Rosen

Staff member
Super Moderator
#9
Does the "prevent mix up" clauses of QSR and ISO require any documentation?
It's required.
Subpart L--Handling, Storage, Distribution, and Installation
Sec. 820.140 Handling.
Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#10
We will, of course, write our SOPs with that in mind but the actual floor layout...does it need a control document?

It's required.
Subpart L--Handling, Storage, Distribution, and Installation
Sec. 820.140 Handling.
Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.
 
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