Tuesday, November 15, 2016

Engineering Change Order

In FDA regulated health care life science manufacturing industry, 21 CFR Part 820 Quality System Regulation is very important for good manufacturing practise for the medical device.

Engineering Change is an important topic. I would like to pen down my experiences before all faded away.

Engineering Change Order (ECO) will trigger the following requirements:

(1) Input Optimization Concept to elaborate the changes description/ benefits and impacts.

(2) Release Engineering Change Order (ECO) to manufacturing plant.

(3) Document list changes to have respective department representatives to review the changes impact on R&D/LCM, GPS, SCM, PE, V&V, RA, etc.

(4) Change form LCM (Life Cycle Management) instrumentation should be filled too.

If the ECO cannot be released at the short period of time, a temporary deviation form can be raised, for example: ANF- Approval /Notification Form.

Most of the engineering changes are due to:

(1) Correction of the engineering drawings (be it drawing errors/discrepancy), production documentation (update on assembly build instruction), BOM correction (part quantities mismatch between the BOM and the exact usage on the production line, for example the screws quantities, etc.), packing list updates.

(2) End of life (EOL) part proposed by the vendor/manufacturer that leads to new MPN change. RoHS and REACH compliances must be declared. Electrical characteristics shall be reviewed. Critical changes like photomultiplier tube (PMT), rotor coupling, stepper motor will require trial report and evaluation report for careful studies and comparison. Such change will also impact the SP (Specification) document. It has DHF (Device History File) impact.

DHF impacted changes will also required re-validation. It depends from the scope of the change and impact to the end results. Such change can also impact the application side (chemistry, reagents and assays).

There will be no change in form, fit and functional.
FDA auditors always like to see such statement stated in the Engineering Change Order. It implies that you have gone through the changes carefully, thoroughly.

(3) Escalated customer complaints (from Global Product support) leads to investigation of the problem. Design change/ improvement will eliminate or reduce the occur rate of the incidents. For example, the cable bending for too long causes intermittent. It shall be replaced by higher class of cable materials that can hold millions of bending cycles.

(4) Production software updates. User manual CD, software updates (on the BOM level) or spare part changes, new spare part added into the list.

(5) New OEM implementation. (Different label information and cover colour for example).

(6) Cost reduction project. For example to reduce the instrument 48 hours burn in test to 8 hours run in test.

(7) Refurbish protocol update (for exhibition pool, demo units)

(8) Production transfer, for example from California to Malaysia. The Production Release report must be assessed and completed then an Engineering Change Order can be released accordingly.

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