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Standard Operating Procedures and OPS
This newsletter describes the Standard Operating Procedures (SOP) Operating Procedures System (OPS) which the Vitamin Consultancy maintains for our monthly retainer clients.
Operating Procedures System - OPS
Dietary Supplement purveyors face an ever-changing regulatory climate as various federal agencies, led by FDA, seek to control the market. After practicing law for 36 years, gaining a reputation as The Vitamin Lawyer, I focused my efforts on The Vitamin Consultancy which brings top-level regulatory services to medium and small vitamin companies.
Those services include not only FDA-vetted, GMP compliant Standard Operating Procedure (SOP) formats, but also a webinar training program that teaches how to use SOPs to meet regulatory requirements -- and more, with specialized webinars on topics such as The Forbidden Words, to keep your company ahead of the curve. I provide GMP audits and copy/label/claims reviews.
In addition to keeping an eye on FDA regulatory developments through the Agency web site and various industry newsletters, I also have people coming to me for my advice who have been recently inspected by FDA and received "Comment" letters. Often these letters are an "early warning" of FDA regulatory focus, giving me the opportunity to prepare you for the changing regulatory environment.
As a result of some language used in a recent FDA letter to a company selling homeopathic patches, I saw that FDA was recommending certain language, in effect, for the Quality Control (QC) parts of the SOPs, more clearly specifying the role of the Quality Control Manager (yes, in a small company the CEO/COO may also be the QCM), so I created certain amendments to the SOPs to cover this new FDA focus and clarify the role of the QCM.This is one way for Vitamin Consultancy clients to stay a head of the curve. [BTW, I am working on a new webinar about the role of the QCM.]
While there is a Change Procedure in the SOPs, how will such changes be communicated and implemented?
I've been thinking, therefore, about how to more effectively automate the process. I suggest it may be time to "go digital" with the Operating Procedures System -- OPS.
Using the paper file hard-copy as a back up, the company could have a private [password protected] online OPS copy as the official copy.
Even, or especially, in an emergency managers would have access to necessary procedures from their smart phones that would give them always up-to-date copies of the procedures. Properly indexed with hyperlinks, the necessary information would always be available, and, perhaps more importantly, FDA would see that there is a system in place to ensure that the most up-to-date procedures are being implemented.
In addition to the SOP format that I've prepared there are probably other formal or informal operating procedures that should be recorded, not necessarily for FDA compliance, but for brand and operations consistency.
The Operating Procedures System could become a repository for the company culture, for such essential factors as the Company Branding Profile (see article below).
Properly developed and maintained, the OPS can be a valuable company asset.
The Vitamin Consultancy's SOP Maintenance System provides your company with a powerful tool for the continued regulatory compliance of your operations. Here is how it works:
1. The Company and the Consultancy enter into a privacy contract for the maintenance of the OPS. The maintenance fee is included in the monthly retainer.
2. The SOP document, based on the Consultancy format, is finalized with the Company and posted on the protected site. Only the OPS Administrator, provided by the Consultancy, has authority to change the document (and with company COO approval). Additional operations documents that may be useful can also be posted, under COO direction.
3. The Company specifies which managers are to have access. That access is granted to specific email addresses and can be password protected. At any time access can be terminated.
4. The Consultancy will keep the SOPs up-to-date and will notify the managers, through the master list, of changes.
5. These procedures will themselves be set down in a new SOP specifying the OPS Online Official SOPs.
Here is an outline of the Operating Procedures System:
 The SOP document details the operating procedures of the Company, in conformity with FDA and FTC regulations of dietary supplement and similar businesses. See SOP Index below.
 The OPS is the private online repository for the updated official copy of the SOP document, available to the managers of the Company.
 The OPS consists of a Google Documents file folder and subfolders with the following items:
- The OPS Use Memorandum
- The SOP indexed manual consisting, currently, of 24 specific SOPs
- The SOP Appendix with standard forms
- The Company Branding Profile
- The CCDS (Company Core Data Sheet) for each current product.
1. Introduction / Index
2. Refund, Delivery & Returns Policies
3. Standard Disclaimers; Site Use Statement
4. Standard Waivers: Model – Testimonial – Clinical Study
6. Document Retention Policy
7. Quality Control / Claims Control / Complaints
8. Contract Manufacturer Agreement GMP Enforcement Terms
9. Password and Internet/Program Access Controls
10. Order Processing Procedure
11. Bookkeeping and Account Management
12. Order Record Keeping and Retrieval; AER Reporting
13. Emergency Planning and Crisis Management
14. Payment Card Industry Data Security System
15. Private Labeling / Labels
16. Receiving, Handling, Shipping & Storage of Inventory and Returns
18. Complaint Form
19. Change Controls / New SOPs
21. CCDS (Company Core Data Sheets)
22. New Employee Qualification and Training
23. Official Inspections: Procedures
24. New Product Development; Product Retirement & Archiving
 The SOP Appendix includes these forms:
Social Media Schedule / Program Access
 These are records are kept in the ordinary course of business and may be offered as evidence in court. The Branding Profile is an expression of the company’s Intellectual Property and claims to trademarks, trade dress and branding indicia.
 The following Positions in the Company are listed in the SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager.
The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO
 All managers shall maintain online access to the current SOPs at all times; for example, on their smart phones.
 The private link to the OPS Google Docs folder which includes the SOPs can be provided to anyone in the company, or any consultant, who needs access to the OPS
Depending on company size, the Vitamin Consultancy can maintain your OPS and their contents for as little as an hour a month retainer. For that you receive our guidance on developing your SOPs, including FDA-compliant forms, your basic Company Branding Profile (more about that below) and our private client alerts regarding breaking FDA and FTC news impacting natural products. Of course, we set up and maintain your OPS online.
Interested? Call Ralph: 973.300.4594. We invoice monthly through PayPal.
What is a company Branding Profile? It is an organized document that is part of the Intellectual Property of the company. It adds value to the company by better defining the company brand.
The Profile covers such issues as patents and trademarks, slogans; trade names and logos; precisely what colors represent the company; what typeface fonts; what types of images, the "look and feel" of the labeling and sales copy (trade dress; branding indicia). Standard advertising language may be cataloged. The Company Mission should be included.
One Branding Agency lists:
"The brand codification process typically involves defining and aligning elements like:
- Target audience / segments
- Target beliefs & perceptions
- Target options / competitors
- Value proposition
- Speaking points
- Selling points
- Tone & manner
- Visual profile
- Brand persona
- Brand architecture
- Vision, mission, goals"
The Branding Profile is intended to offer guidance to the copywriters and customer service people in the company, as well as the planners and managers.
That is why this essential part of the company culture rightfully belongs in the OPS, as one of the chief expressions of the company's mission.