Company Name

Inspection Guide for Food Manufacturer's

1 Personnel
1.a organizational chart
1.b job description
1.c training and assessment
1.d physical medical exam
2 Quality System
2.a complaints and recall procedures; summary list of complaints
2.b batch manufacturing records reivew
2.c non-conformance
2.d change control
2.e contract agreements
2.f approved suppliers and external inspections
2.g audits - internal and external
3 Warehouse for Starting Materials
3.a receipt, handling and storage (materials)
3.b storage areas - quarantine, release, reject, return
3.c storage conditions: temperature and humidity monitoring
3.d status control
3.e approval for use/release to production
3.f finished goods storage
4 Process Flow
4.a Compounding/preparation area
4.b holding tanks
4.c process equipments
4.d cleaning procedure
4.e cleaning/washing area
4.f packaging area
5 Quality Control Laboratory
5.a laboratory design
5.b equipment - calibration and maintenance/logs
5.c sampling procedures/receipt of samples
5.d retension samples
5.e stability program
5.f environment monitoring
5.g out-of-specification
5.h records, workbooks, trends
5.i laboratory staff qualification, training and assessment
6 Document review
6.a documentation system: SOPs/Wis
6.b reports/records of in-house and third party results
6.c reprocessing
6.d product return
6.e batch manufacturing records reivew
6.f specifications and test methods
6.g reference standards/specifications: raw/packaging materials and bulk/finished products
6.h CPR
7 Engineering and Services
7.a preventive maintenance
7.b calibration
7.c pest control
7.d waste disposal management
7.e building management system
7.f consolidation of reports
 1 Personnel
1.a organizational chart
1 Personnel
1.b job description
1 Personnel
1.c training and assessment
1 Personnel
1.d physical medical exam
2 Quality System
2.b batch manufacturing records reivew
2 Quality System
2.e contract agreements
2 Quality System
2.f approved suppliers and external inspections
3 Warehouse for Starting Materials
3.a receipt, handling and storage (materials)
3 Warehouse for Starting Materials
storage conditions: temperature and humidity
3.c monitoring
3 Warehouse for Starting Materials
3.d status control
4 Process Flow
4.a Compounding/preparation area
4 Process Flow
4.b holding tanks
4 Process Flow
4.c process equipments
4 Process Flow
4.d cleaning procedure
4 Process Flow
4.e cleaning/washing area
4 Process Flow
4.f packaging area
5 Quality Control Laboratory
5.b equipment - calibration and maintenance/logs
5 Quality Control Laboratory
5.d retension samples
5 Quality Control Laboratory
5.e stability program
5 Quality Control Laboratory
5.f environment monitoring
6 Document review
6.a documentation system: SOPs/Wis
6 Document review
6.b reports/records of in-house and third party results
6 Document review
6.c reprocessing
6 Document review
6.d product return
6 Document review

reference standards/specifications: raw/packaging

6.g materials and bulk/finished products
7 Engineering and Services
7.a preventive maintenance
7 Engineering and Services
7.b calibration
7 Engineering and Services
7.c pest control
7 Engineering and Services
7.d waste disposal management
7 Engineering and Services
7.e building management system