Information
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LMS Audit - Quality Control
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Plant audited
- corporate
- Montgomery, PA
- phoenix,AZ
- Kingsport, TN
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Conducted on
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Auditors
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750-FRM-0252 rev 1
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752 Quality Control
752.1 Documentation
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Is the documentation validated conform ?
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Procedures: 750-PRC-0008
Instructions: -
Forms/validation: See the DMS Complete Document list to verify the revision of 5 documents
BRC REF: Section 3.1,3.2.1, section 3.3
752.2 Training
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Is the training up to date according to training plan ? Validate the training for 5 employees (position, GMP´s, allergens, etc.)
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Procedure: - 150-PRC-0001
Instructions: - 910-TRN-0001
Forms/validation: - 150-FRM-0003 to 150-FRM-0018, 150-FRM-0021, 150-FRM-0057 and integration forms
BRC REF: 7.1, 7.1.4, 7.4.1
752.3 Non-conformities raised during the last audit are corrected adequately?
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Validate the last audit´s CAR. Are they solved? Are measures in place to prevent the situation from happening again? Are they effective? Is there an action plan submitted for long term CAR?
752.4 Specific Procedures
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752.4.1 Raw Material and Finish Products analysis validation.
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Validate that process form and the procedure are followed, Validate sampling and analysis by the lab technician -
752.4.2 Finish Product Shelf Life Validation Process<br>
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Is the work instruction followed? -
752.4.3 Calibration, validation and third party calibration of lab equipment
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Is the calibration and lab equipment maintenance Program complete and up to date (See records for all equipment)? Are humidity and temperature verified according to the frequency established for cooling rooms, hot rooms and storage zones? (See records) -
752.4.4 CoA Validation Process
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Validate if CoA's on the portal are initialed and have the approbation seal with the date -
752.4.5 Specific certification and programs
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What are specific certifications or factory programs that must be done by quality control? (gluten-free, peanut-free, organic, etc.)
Procedure: 750-PRC-0005 section 1 and 3
Instructions: 752-INS-0001, 750-INS-0006, 750-INS-0027, 750-INS-0028, 752-INS-0008 to 752-INS-0015; 752-INS-0024; 752-INS-0031; 752-INS-0037 to 752-INS-0040; 752-INS-0051; 752-INS-0052, 752-INS-0003, 750-INS-0018, 752-INS-0006
Forms/validation : 752-FRM-0005, 752-FRM-0017 to 752-FRM-0025; 752-FRM-0041; 752-FRM-0044; 752-FRM-0046; 752-FRM-0047; 752-FRM-0056; 752-FRM-0066; 752-FRM-0069, 752-FRM-0035, 750-PRC-0004, 750-PRC-0001, 750-INS-0001, 820-INS-0001, 750-PRC-0003 , SAP, iPAD
BRC REF: 3.5.2.1, 2.14.1, 3.5.1.1, 5.7.1, 6.1.4, 6.1, 6.4.4
Procedure:
Instruction: 752-INS-0041
Forms/ validation:
BRC REF : 5.1.4
Procedures : 750-PRC-0006
Instructions : 752-INS-0002 to 752-INS-0005; 752-INS-0007; 752-INS-0011 to 752-INS-0014; 752-INS-0017 to 752-INS-0024; 752-INS-0026 to 752-INS-0028; 752-INS-0032 to 752-INS-0036; 752-INS-0042; 752-INS-0046 to 752-INS-0050; 752-INS-0055 to 752-INS-0064; 752-INS-0067; 752-INS-0068
Forms/ validation : 752-FRM-0001 to 752-FRM-0009; 752-FRM-0012 to 752-FRM-0014; 752-FRM-0048 to 752-FRM-0055; 752-FRM-0057 to 752-FRM-0060; 752-FRM-0062 to 752-FRM-0065; 752-FRM-0070; 752-FRM-0071; 752-FRM-0073, 752-FRM-0079, 752-FRM-0081See SAP verification equipment module (zplanpm ou IW38)
BRC REF:
Procedures : -
Instructions : 752-INS-0025
Forms/validation: -
BRC REF : -
Procedures: - 750-PRC-0010
Instructions: - 750-INS-0011, 750-INS-0020, 750-INS-0023, 750-INS-0104, 750-INS-0105 750-INS-0110
Forms / validation: -
BRC REF: 5.3.7
