Information
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LMS Audit - Sanitation
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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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710 Sanitation
710.1 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
710.2 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, 150-FRM-0057, integration plans
BRC REF: 1.1.5, section 7.1, 7.1.4
710.3 non-conformities raised during the last audit are corrected adequately?
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Validate the last audit´s CAR. Are they solved? Are effective measures in place to prevent the recurrence of the NC? Action plan submit for long term CAR?
710.4 Specific Procedures
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710.4.1 Instruction for the Residual Material Management
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Procedure: - -
710.4.2 Magnet, filters and sieve verification
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Are protection Mechanisms against foreign bodies adequate (magnet, filters, sieves)? Are Protection Mechanisms regularly verified (see records)? -
710.4.3 Instruction for handling and washing work uniforms<br>
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Is the Washing Procedures efficient? -
710.4.4 Chemical products control Program
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Are the chemical products food grade approved? Choose 5 chemical products and verifiy if they are in the approved product list or not and there utilization. Verify the sanitizer rotation control. -
710.4.5 Validate the sanitation premises<br>
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Are the sanitation premises clean, well maintain and do not contain incompatible material (ex: food grade brushes)? Are the storage areas for chemical products separate from production zones and are their accesses limited to authorized personnel? -
710.4.6 Cleaning Master Schedule in SAP
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Is the Cleaning Master Schedule up to date and complete (including frequency and cleaning methods for all elements of the building and the equipment)? Choose randomly 3 equipment and verify if they are on de cleaning Schedule. -
710.4.7 Pest Management Program
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Is the pest control program adequate? -
710.4.8 Specific Sanitation Program: SSOP and diagrams - Choose documents related to the plant
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Choose some documents. Validate on site. Attend the execution of the equipment clean up to see if the procedure is followed (sanitation protocol 710-INS-0028 et 710-INS-0040) -
710.4.9 CIP
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Is a schematic diagram of the layout of the CIP system including process piping circuits available? -
710.4.10 Certification or specific program
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What needs to be done by sanitation regarding certification or specific programs (gluten-free, peanut-free, organic, etc.)?
Instructions: 710-INS-0149
Forms/validation : -
BRC REF: 4.12.1 to 4.12.3
Procedure: -
Instruction: 710-INS-0029, 750-INS-0010
Forms/ validation: 710-FRM-0014, 710-FRM-0074, 710-FRM-0092, 710-FRM-0113, 710-FRM-0114, 752-FRM-0016, 710-FRM-0191, 710-FRM-0200
BRC REF : 4.10.4.1, 4.10.2.1, 4.10.2.2
Procedure : -
Instruction : 710-INS-0038
Forms/ validation : -
BRC REF: 7.4.3
Procedures : -
Instructions : 710-INS-0069, 710-INS-0001, 710-INS-0108, 750-INS-0009,710-INS-0167
Forms/validation: 710-FRM-0013, 710-FRM-0002, 710-FRM-0122, 710-FRM-0128, 710-FRM-0187, 710-FRM-0216
BRC REF : 4.7.6, 4.9.1.1
Procedures : -
Instructions : -
Forms/validation: -
BRC REF : -
Validate if new equipment from the last year are in the Schedule. Validate the documentation of 3 equipment that cleanliness is questionable (Schedule: method, frequency, last cleaning confirmation). Does all the equipment added to the after production cleaning diagrams?
Is changeover cleaning sequence is up to date?
Are all premises and equipment are kept clean and in hygienic conditions?
Procedures : 710-PRC-0001 point 3.1
Instructions : -
Forms/validation: -
BRC REF : 4.11, 5.3.8
License up to date, verify the network maps vs some devices, Insurance certificate up to date?
The visits calendar is available and respected? Pesticides are food grade approved?
Network up to date?
Verify some devices on site: clean, in good condition, identified on the wall?
Once a year verify the technician's job by placing false captures in the devices
Validate the Corrective Action demands and their processing time.
Are there obvious facts of contamination by insects, rodents or others?
Is the Pest Control Program with trend charts analysis done annually?
Is the network reviewed and conform?
Is the annual risk analysis done? (dated less than one year)
Are employees able to recognize signs of pest activity? Are they aware they should report pest activity to designated manager?
If pest activity is identified it shall not present a risk of product contamination, raw materials or packaging. The presence of any infestation on site shall be identified in pest control records and be part of an effective management program to eliminate or manage the infestation such that it does not present a risk to products, raw materials or packaging .
Procedures : -
Instructions : 710-INS-0077
Forms/validation: 710-FRM-0244
BRC REF : 4.11.1, 4.14.1 to 4.13.8, 4.14.11
Procedures : 710-PRC-0001 point 3.2
Instructions : 710-INS-0002 to 710-INS-0193
Forms/validation: 710-FRM-0005 to 710-FRM-0238
BRC REF : -
Is there an inspection report or other validation that the systems are hygienically designed with no dead areas, limited interruptions to flow streams and good system drain ability?
Scavenge/return pumps are operated to ensure that there is no build-up of CIP solutions in the vessels.
Spray balls and rotating spray devices effectively clean vessels by providing full surface coverage and are periodically inspected for blockages.
CIP equipment has adequate separation from active product lines (e.g. through the use of double seat valves, manually controlled links, blanks in pipework or make-or-break connections with proxy switches as interlocks) to prevent or safeguard against cross-contamination.
The system shall be revalidated following alterations or additions to the CIP equipment. A log of changes to the CIP system shall be maintained.
The CIP equipment shall be operated to ensure effective cleaning is carried out :the process parameters, time, detergent concentrations, flow rate and temperatures shall be defined to ensure removal of the appropriate target hazard (e.g. soil, allergens, vegetative micro-organisms, spores). This shall be validated and records of the validation maintained.
Detergent concentrations shall be checked routinely.
CIP process verification shall be undertaken by analysis of rinse waters and/or first product through the line for the presence of cleaning fluids or by tests of ATP (bioluminescence techniques), allergens or micro-organisms as appropriate.
Detergent tanks shall be kept stocked up and a log maintained of when these are drained, cleaned, filled and emptied. Recovered post-rinse solutions shall be monitored for a build-up of carry-over from the detergent tanks.
Filters, where fitted, shall be cleaned and inspected at a defined frequency.
Procedures : -
Instructions : 710-INS-0154, 710-INS-0156
Forms/validation: 710-FRM-0038, 710-FRM-0214, 710-FRM-0215
BRC REF : 4.11.7.2, 4.11.7.3
Procedures : 750-PRC-0010
Instructions : 7507-INS-0011, 750-INS-0020, 750-INS-0023, 750-INS-0104, 750-INS-0105, 750-INS-0110
Forms/validation: -
BRC REF : 5.3.7
