Weekly QA Audit / Check 2022

• Conducted on

  Date

• Prepared by: A Cameron

  Select Dougie Davidson Lorna Irving Angus Cameron

  • Dougie Davidson
  • Lorna Irving
  • Angus Cameron

Instructions

• Progress through the following sections, answering each question. When an item is non-compliant, be sure to add notes and photos as evidence.

Spill Kits Check (Factory & Bottling Area)

• Check the three Spill Kits in area for Stock levels - Advise Lynn if levels are low

  Yes

  No

  N/A

Personnel Hygiene

• Has the flushing regime been completed on the emergency and male toilet showers?

  Yes

  No

  N/A

GMP Checks Audits

• Check the Calibration has been carried out on all Scales in the Consumer Solutions & Tableting areas using form 6.3.3.9.

  Yes

  No

  N/A

• Has the daily Individual Equipment daily Cleaning log 6.3.3.7. been carried out?

  Yes

  No

  N/A

• Check the Personnel Records 6.2.3.3. are up to date and applicable to the tasks being carried out

  Yes

  No

  N/A

• Has the Quality Assurance Task Form been filled out

  Yes

  No

  N/A

• Check the CAPA Folder and review Open and Closed CAPA's

  Yes

  No

  N/A

• Check that all Scheduled Audits in the Internal / External Audit Plan 6.9.1.1. have been completed and marked as completed in the Internal / External Audit Register 6.9.1.2.

  Yes

  No

  N/A

• Has the daily Housekeeping Log 6.2.4.7. been filled out for the Laboratory

  Yes

  No

  N/A

• Has the daily Housekeeping log 6.2.4.3. been filled out for Clean Room 1

  Yes

  No

  N/A

• Has the daily Housekeeping log 6.2.4.3. been filled out for Clean Room 2

  Yes

  No

  N/A

• Has the Weekly Housekeeping log 6.2.4.4. been filled out for Clean Room 1

  Yes

  No

  N/A

• Has the Weekly Housekeeping log 6.2.4.4. been filled out for Clean Room 2

  Yes

  No

  N/A

• Has the Weekly Housekeeping log 6.2.4.8. been filled out for Laboratory

  Yes

  No

  N/A

• Check the Chlorosan Tub Labels (Stock Level - minimum 1000) - Check at the end of every Month.

  Yes

  No

  N/A

• Has the Label Acceptance Form 6.5.7.1.1. been carried out?

  Yes

  No

  N/A

• Has the Tub and Lid Acceptance Form 6.5.7.2.2. been carried out?

  Yes

  No

  N/A

• Has the Box Acceptance Form 6.5.7.3.2. been carried out?

  Yes

  No

  N/A

• Has the Equipment Maintenance Form 6.3.3.8. been carried out?

  Yes

  No

  N/A

• Has the Production Recording Sheet 6.5.6. been carried out?

  Yes

  No

  N/A

• Has the PPE - Duraflow Maintenance 6.2.4.2. been carried out and are there any issues highlighted by the operator?

  Yes

  No

  N/A

• Has the Materials Sample Log 6.5.3.8. been carried out?

  Yes

  No

  N/A

• Review the Document folder and review recent Creation or Change requests have been actioned and logged.

  Yes

  No

  N/A

• Has the Starting Materials Acceptance Form 6.5.3.4. been carried out. Check correlation with Material Testing Form 6.5.3.7.*.2 and check for C of A or C of Q.

  Yes

  No

  N/A

• Does the Contamination Control Form 6.5.2.2. reflect the production schedule.

  Yes

  No

  N/A

• Check the Calibration has been completed daily in the Lab for the PH Meter

  Yes

  No

  N/A

• Review the Live Document Register for Documents up for their yearly Review

  Yes

  No

  N/A

Factory Checks

• Fire Exits Access is Clear.

  Yes

  No

  N/A

• Check that the Fire Alarm Test was carried out on the previous Wednesday

  Yes

  No

  N/A

• Review the Accident and Near Miss Folder for Actions Closure or Updates

  Yes

  No

  N/A

• Check the Forklift Daily & Weekly Checks have been completed

  Yes

  No

  N/A

• Is the forklift service overdue.

  Yes

  No

  N/A

• Is the scissors lift service overdue.

  Yes

  No

  N/A

• Check the Duraflow Battery Charging Board and make sure all 8 chargers are operational

  Yes

  No

  N/A