CA Cold Storage

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

Policy/Procedure

• Is there a policy in place that establishes a protocol for the temperature of cold storage areas?

  Yes

  No

  N/A

• What documents contain those policies?

• What is the temperature requirement for cold storage areas?

Physical Site

• Have temperature logs for cold storage areas been properly maintained?

  Yes

  No

  N/A

• Explain

• Are racks and shelving in cold storage areas corrosion resistant and easily cleanable?

  Yes

  No

  N/A

• Explain

What is the temperature of the freezer upon inspection? What is the temperature of the refrigerated upon inspection?

• No noticeable ice or condensation buildup was observed during inspection.

  Yes

  No

  N/A

• Explain:

  Good

  Fair

  Poor

  N/A

• What evidence exists that materials requiring refrigeration are kept at appropriate temperatures during transit?

• Are there presently materials requiring refrigeration sitting outside cold storage areas?

  Yes

  No

  N/A

• What products?

Responsibilities

• Who is responsible for checking the temperature of cold storage areas?

GMP

• What determines if a product or raw material needs to be refrigerated?

  Yes

  No

  N/A

• Are temperature measuring devices calibrated?

  Yes

  No

  N/A

• When were the last calibrations?

• Is there ever a situation where visitors may be exempt from following GMPs?

  Yes

  No

  N/A

• Explain

• Are items in cold storage clean?

  Yes

  No

  N/A

• Are items in cold storage kept off of the floor?

  Yes

  No

  N/A

Food Safety

• Is there a notification system should power to cold storage fail during off hours?

  Yes

  No

  N/A

• Describe

• Is there backup refrigeration available in the event of a power failure?

  Yes

  No

  N/A

• Describe

Quality

• What measures are taken to ensure that items requiring refrigeration don't sit at temperatures higher than the allowable range?

• How is refrigerated product suspected of being stored at higher than allowable temperatures reevaluated?

Electronic Records

• How does the ERP system identify what needs refrigerated storage?

• Are all electronic records stored in a secure location?

  Yes

  No

  N/A

Record Retention

• How are cold storage logs stored and for how long?

Findings

• Minor

Minor Finding

• Description of Finding

• Major

Major Finding

• Description of Finding

• Critical

Critical Finding

• Description of Finding

• Corrective actions from findings:

Follow-up

• Short term corrective actions completed?

  Yes

  No

  N/A

• Date short term corrective actions completed

  Date

• Long term corrective actions completed?

  Yes

  No

  N/A

• Date long term corrective actions completed

  Date

• Verifier of corrective action completion:

  Sign

Results

• Did the system being audited pass or fail?<br>Pass = <10 minor findings and no major or critical findings<br>Fail = >9 minor findings or any major or critical findings

  Pass

  Fail

• Results communicated to auditee?

  Yes

  No

  N/A

Auditor Signature

Auditor

• Auditor Signature

  Sign

• Auditor Title

• Date of Signature

  Date