5 replies to this topic

[DANAT]

In all of our module documents we have signatures of the company owner and SQF practitioner.  This was started by the previous practitioner. I can't seem to find any clear definition as to this process and what signatures are mandatory. Can anyone further elaborate on this. 

 

Thanks

[Anteneh]

We had our senior management (mostly sqf practioner or the CEO) review and sign all policies  after initial writing and set up of our documents to show that we wrote and understood to commit to what we have put in place. Then we scanned the original approved and signed documents for documentation purposes and incase we are asked by the auditor if they were ever reviewed by senior management. But we don't necessarily have the signatures there after. And the auditor doesn't seem to be bothered by it. 

 

On the other hand site's commitment to establish and review food safety objectives policy statement shall be Signed by senior site management. 

[Hoosiersmoker]

What Anteneh said, if it doesn't specifically call for signatures it isn't required.

[billbrochin]

In the Peanut Corporation of America tragedy, upper management tried to use the "I didn't know" excuse.  It did not go over well with the FDA investigation.  I may be going overboard, but all the documents I create/revise are signed by the owner and me every time.

[AltonBrownFanClub]

In the Peanut Corporation of America tragedy, upper management tried to use the "I didn't know" excuse.  It did not go over well with the FDA investigation.  I may be going overboard, but all the documents I create/revise are signed by the owner and me every time.

I agree with this strategy. Although it may not be required to have their signatures, it will show they were informed of changes.
 

I also maintain a Word document that outlines every revision/addition I have made since starting.

If we want to talk overboard, BCCing a personal email is never a bad idea. Especially when mentioning a problem you feel upper management may not take as seriously as you do. 

[Anteneh]

As billbrochin mentioned above, FDA definitely does require it. CFR - Code of Federal Regulations Title 21 117.335 requires documents to include date and signature. I have attached the whole regulation below for your reference. In this case it is good to have the signatures. 

 

[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2020] [CITE: 21CFR117.335]  

 

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION

PART 117 -- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

Subpart F - Requirements Applying to Records That Must Be Established and Maintained

Sec. 117.335 Special requirements applicable to a written assurance.

(a) Any written assurance required by this part must contain the following elements:

(1) Effective date;

(2) Printed names and signatures of authorized officials;

(3) The applicable assurance under:

(i) Section 117.136(a)(2);

(ii) Section 117.136(a)(3);

(iii) Section 117.136(a)(4);

(iv) Section 117.430©(2);

(v) Section 117.430(d)(2); or

(vi) Section 117.430(e)(2);

(b) A written assurance required under § 117.136(a)(2), (3), or (4) must include:

(1) Acknowledgement that the facility that provides the written assurance assumes legal responsibility to act consistently with the assurance and document its actions taken to satisfy the written assurance; and

(2) Provision that if the assurance is terminated in writing by either entity, responsibility for compliance with the applicable provisions of this part reverts to the manufacturer/processor as of the date of termination.