Here are a few suggestions about implementing your purchased medical device SOP:
1. Carefully read the SOP and be sure you understand what the procedure requires your company to do
2. If there are conflicts between the SOP and company practice, they must be resolved. If your company is not doing an activity described in the SOP it must start. If your company is doing something different, it must be decided if current company procedure is in FDA compliance. If compliant, the SOP may be modified to conform to your practice.
3. Determine if responsibilities are assigned to the correct functional groups. If not, change titles in the SOP.
4. Convene a meeting of all affected groups and discuss the SOP and its requirements. Objections and concerns should be dealt with before SOP approval and implementation. Lack of buy-in by affected groups could lead to personnel not following the SOP and subsequent discovery of this during an FDA audit, leading to Observations and Warning Letters. Customization may be done at this point.
5.Before approval the SOP should undergo a "dry run" to be sure the procedure can be followed. Just reading the SOP is not adequate.
6. SOP should be approved by appropriate management. Approval should be in writing.
7. Official numbered copies should be distributed to all affected groups and a log kept by Quality Assurance. Copies should be readily accessible to all affected personnel and they should all know the location of the copy. FDA will definitely ask personnel if they know where their referral copy is kept. Electronic systems are helpful here.
8. Training on the SOP should be conducted before implementation. This can be accomplished very simply at a short meeting. Each person should receive a copy of the SOP to review prior to the meeting. The instructor explains the SOP and answers questions. Training should be documented and training logs filed by Quality Assurance. The copies of the SOP should be collected following the meeting and destroyed. Training copies are destroyed so that nobody uses an obsolete, and potentially erroneous, training copy instead of a copy of an approved SOP.
9. Several months following implementation an audit should be conducted to assure personnel understand the SOP and are following the SOP to the letter. If discrepancies are found and the deviation is determined to be more appropriate, the SOP may need to be revised following a document revision procedure which includes management approval.
10. If there are any complications, reasonably priced consultation services are available from Medical Device SOP Advisors. Refer to the "Services" section on the menu.