Design and Construction
1.1 The facility grounds are well maintained, including pathways, parking lots, lawns, and drainage areas.
1.2 Sufficient space is provided for the orderly placement of equipment and materials to avoid mix-ups and contamination.
1.3 Appropriate environmental controls exist and are maintained (controlled temperature, air filtration, humidity, lighting, etc…).
1.4 All food contact surfaces are made of materials appropriate for the application (ie stainless steel vs. aluminum).
1.5 All water systems are adequately protected against backflow.
1.6 There are adequate handwashing facilities in restrooms, break areas, and manufacturing areas.
1.7 The floors, walls, ceilings, doors and windows are completely sealed to prevent the entry of pests.
1.8 Loading dock doors are flush with the floor when closed.
1.9 There is separation of defined areas and adequate controls to prevent contamination.
Construction and Maintenance
2.1 Non-toxic and corrosion-resistant materials, such as stainless steel, are used throughout the process.
2.2 The seams are well joined and smooth.
2.3 The lubricants and chemicals used to operate the equipment are approved for food grade applications.
2.4 A preventive maintenance program developed and implemented for major equipment.
2.5 Weighing, measuring, monitoring, and testing equipment critical to quality assurance must be calibrated according to written procedures, established schedules, and using certified or traceable standards.
Pest control program
3.1 There is a documented pest control program.
3.2 The exterior of the building is protected against the entry of rodents and pests.
3.3 Map with the location of all identified traps
3.4 The pest control program includes frequent inspections.
3.5 Supplier maintains and enforces written procedures for pesticide application.
3.6 All chemicals used in pest control are accurately labeled and safely stored.
3.7 The facility audits the performance of the pest control operator.
Cleaning and sanitation
4.1 There is a written and complete program for the sanitation of plants and equipment.
4.2 Maintenance of facilities and equipment ensures the safe manufacture of healthy foods.
4.3 There are written operating procedures or work instructions.
4.4 Brushes and other utensils used to clean food contact surfaces are controlled and clearly identified.
4.5 Measures are in place to verify and monitor the effectiveness of cleaning methods.
4.6 Cleaning and disinfection procedures are validated and well documented as such.
4.7 Usage and cleaning records established for major equipment including: dates, products, lot numbers, person who used, person who cleaned.
4.8 Hoppers, tanks and similar food containers must be properly covered.
4.9 A chemical control program manages the use, storage and handling of non-food chemicals in manufacturing facilities.
General controls
5.1 There should be written procedures that describe the receipt, identification, quarantine, storage, handling, sampling, testing, and approval or rejection of materials.
5.2 There must be a system for the control of GMO/non-GMO allergens.
5.3 There must be a system for the control of GMO/non-GMO allergens.
5.4 Manufacturers of intermediates and/or APIs must have a system to assess suppliers of critical materials.
5.5 Materials must be purchased to an agreed specification, from a supplier(s) approved by the quality unit(s).
Traceability
6.1 Lot tracking system with distinctive lot number for all raw materials, in-process materials, finished goods and packaging components.
6.2 Establish and document First-in/First-out (FIFO) procedures for all materials and assets.
Storage
7.1 Materials must be handled and stored in a manner that prevents degradation, contamination, and cross-contamination.
7.2 temperature and humidity
7.3 Containers designed to protect against adulteration.
7.4 Store and/or control rejected materials in separate facilities to prevent their use.
7.5 The warehouse area is clean and tidy: an 18″ perimeter is maintained.
7.6 Materials should be re-evaluated, as appropriate, for suitability for use (eg, after prolonged storage or exposure to heat or moisture).
Process Quality Control Plan (Packaging / Raw Materials)
8.1 There is a developed plan that indicates the frequency of inspection, the number of samples and the tests required
8.2 Procedure for OOS results, how this information relates to production, what is done with the product
8.3 Systems are in place to ensure that you have and follow the most up-to-date customer specifications.
8.4 Does QC have a product standard reference system?
8.5 Are there sufficient resources (qualified people, test equipment, etc.) to adequately perform this function?
8.6 Are product retentions (finished, raw material, packaging) kept for a minimum of useful life + 1 year?
Incoming quality control
9.1 There is a developed plan that indicates the frequency of inspection, the number of samples and the tests required.
9.2 There is a procedure for handling results out of specification (OOS).
9.3 Does QC have updated product specifications?
9.4 Are customer product standards available and used?
9.5 Are there sufficient resources (qualified people, test equipment, etc.) to adequately perform this function?
Quality control microlaboratory
10.1 There is a developed plan that indicates the frequency of inspection, the number of samples and the tests required
10.2 There is a procedure for handling results out of specification (OOS).
10.3 Does Micro QC have updated product specifications?
10.4 Are there sufficient resources (qualified people, test equipment, etc.) to adequately perform this function?
10.5 Is there a documented and effective laboratory cleaning and disinfection program that includes environmental monitoring?
10.6 Is there a documented calibration and maintenance program?
10.7 Is there a validation program?
Analytical quality control laboratory
11.1 There is a developed plan that indicates the frequency of inspection, the number of samples and the tests required
11.2 There is a procedure for handling results out of specification (OOS).
11.3 Does Analytical QC have updated product specifications?
11.4 Are there sufficient resources (qualified people, test equipment, etc.) to adequately perform this function?
11.5 Is there a documented calibration and maintenance program?
11.6 Is there a validation program?
11.7 Is there a process for maintaining laboratory standards?
11.8 Is there a process for the control and documentation of laboratory reagents?
11.9 Establish, validate and document test methods.
Batch records
12.1 All documents related to the manufacturing of intermediates or active pharmaceutical ingredients (APIs) must be prepared, reviewed, approved, and distributed in accordance with a written SOP. Batch record:
12.2 It will contain a list of raw materials, names, characteristics, identification, batch number(s), weights.
12.3 It will include total and theoretical weights/measures, minimum/maximum percentage. (Values outside of acceptable ranges require investigation).
12.4 It will include detailed manufacturing instructions and process control set points to ensure consistent purity, quality and composition.
12.5 It will include documentation of each significant step in the manufacturing process.
12.6 It will contain special investigation/deviation notes from the prescribed process.
12.7 It will be reviewed and approved by Quality Assurance (QA) for each individual batch run.
12.8 It will be kept for at least 1 year after the expiration date of the batch.
Pollution
13.1 Any material found to have an insect infestation should be quarantined and immediately removed from the facility.
13.2 Effective measures shall be taken to protect against foreign metals and materials.
General controls
14.1 Identify and record the use of all containers, processing lines and major equipment during production.
14.2 Carry out the filling, assembly, packaging and other operations in such a way that the products are not adulterated.
14.3 Methods for establishing and monitoring critical process control points must be established in writing.
Manufacturing process controls
15.1 Developed plan indicating inspection frequency, number of samples, required tests
15.2 There is a procedure for out of specification results. What is done with the product?
15.3 Are product standards routinely used?
15.4 Is production set up to meet customer specifications and requirements?
15.5 Are there sufficient resources (qualified people, intermediate and final process controls, etc.) to ensure the production of a quality product?
General controls
16.1 Establish and follow the procedure for receipt, storage, handling, sampling, examination, and reconciliation of packaging materials.
16.2 Establish and follow the procedure to ensure that the correct labels, labeling and packaging materials are issued and used.
Issuance and control of labels
17.1 Access to label storage areas must be limited to authorized personnel.
17.2 Procedures should be established to reconcile the quantities of tags issued, used, and returned.
17.3 Procedures should be established on how to investigate/assess any discrepancies found between the number of packages labeled and the number of labels issued.
17.4 Procedures should be established for the destruction of obsolete and expired labels.
17.5 The printed labels issued for a lot must be carefully examined to verify their identity and conformity with the specifications of the master production record.
17.6 A printed label representative of those used must be included in the batch production record.
Packaging and labeling operations
18.1 Provide adequate separation between different packaging/labeling operations that are carried out simultaneously in the same area.
18.2 Identify containers and ingredients with a batch number that allows determining the history and batch control.
18.3 Examine packaged and labeled products to ensure they have the correct label and lot number.
18.4 Make sure proper line clearance procedures are in place and used during shifts.
Quality objectives
19.1 There is an organization chart that reflects the current structure of reports and responsibilities.
19.2 Does the organization have an established and maintained quality management unit?
19.3 There is a management representative with defined authority and responsibility to meet customer compliance.
19.4 Qualified technical personnel are available for design, process, product, and service support.
19.5 A quality manual has been developed detailing the quality system of policies and procedures.
19.6 The quality manual procedures identify • Who is responsible for the action? • What is there to do? • When are actions required?
19.7 Responsibility for updating and revising the quality manual and system is well defined.
19.8 The company’s quality objectives are documented, signed and dated.
19.9 Quality objectives are communicated, understood and maintained throughout the organization.
19.10 Written procedures address the following types of planning:
19.11 • Establishment of requirements
19.12 • Verification of requirements
19.13 • Acceptance procedures
19.14 • Quality information systems
19.15 • Customer satisfaction
19.16 • Change of control
19.17 Continuous quality improvements are part of the plant manager’s goals.
19.18 Quality costs are used for evaluation and planning.
19.19 There is documented evidence that advanced quality planning activities are reviewed with clients.
Effectiveness of Quality Management Systems
20.1 Delivery times are measured and tracked
20.2 The total cost of quality is tracked.
20.3 Measured and tracked cycle times
20.4 Annual quality improvement goals are set by top management
20.5 The objectives are periodically reviewed by senior management.
20.6 There is a system to verify that the objectives are met and the quality policy is complied with.
20.7 The achievement of quality objectives is a high priority in overall performance reviews.
20.8 The quality manual is periodically reviewed, revised and communicated throughout the organization.
20.9 There is a documented and objective process for measuring and tracking customer satisfaction.
Internal audits
21.1 There is a documented procedure for conducting internal quality audits.
21.2 Internal audits are carried out every six months or are scheduled according to the status and importance of the activity.
21.3 The audit includes the work environment and general cleanliness.
21.4 The results of the internal audit are documented and brought to the attention of management.
21.5 There is an established and documented complaint investigation and response program.
21.6 Establish and document the rework and rework procedure
21.7 Corrective actions are timely, recorded and evaluated to determine their effectiveness.
Qualifications and Experience
22.1 An organization chart is available that reflects the most current reporting structure.
22.2 Job descriptions throughout the organization include responsibilities for supporting quality objectives.
22.3 There is an adequate number of qualified personnel to perform manufacturing, packaging and quality control functions.
hygiene practices
23.1 Are there hygienic practices to protect against food contamination?
23.2 Staff must wear clean clothing suitable for the manufacturing activity. When necessary, additional protective clothing such as head, face, hand, and arm coverings should be worn.
23.3 Any person, by medical examination or supervisory observation, who is shown to have, or appear to have, an open illness or injury for which there is a reasonable possibility that food, food contact surfaces, or food packaging is contaminated, they will be excluded from any operation until the condition is corrected.
23.4 Staff should be instructed to report such conditions to supervisors.
23.5 Designated areas outside the processing zones have been provided for clothing and other personal belongings (jackets, cell phones, bags, radios, CD players, headphones, pagers).
23.6 The consumption of food and beverages, chewing gum or the use of tobacco products are strictly prohibited in the processing areas.
23.7 Proper handwashing practices are reinforced with signs posted in break rooms, production areas, and restrooms.
23.8 There are written procedures that address and include adequate control and supervision of the above practices.
Training procedures
24.1 Have procedures been established and used to identify training needs? Training procedures should be in place for all levels, including temporary and part-time staff, management, visitors, construction/contract staff, consultants, government, and client auditors.
24.2 The procedures address training schedules, such as hiring, future training requirements, follow-up, and/or training frequencies.
24.3 The effectiveness of the training is periodically evaluated.
24.5 Are qualification and training records maintained for all staff?
24.5 Are qualification and training records maintained for all staff?
24.6 Are the qualification and experience requirements of the trainers defined in the training procedures?
24.7 Training records must be maintained for all staff and must include: date, topic, instructor name, employee signatures, tests, quizzes, etc.
24.8 Training records must be maintained for all staff and must include: date, topic, instructor name, employee signatures, tests, quizzes, etc.
Shopping
25.1 Is there a system to notify customers of delivery days?
25.2 How are they notified? Email, fax, phone, mail? Is this documented?
25.3 What systems or processes are in place for cost of quality (ie scrap, reduction, rework, commodity planning)?
25.4 An updated organization chart with names/key personnel available.
Customer Support
26.1 Is there evidence of a Customer Service System?
26.2 Company contact list.
26.3 Is there a process to request samples or information?
Generalities
27.1 Are there contingency plans for major problems (fire, tornado, flood, etc.)?
27.2 Is there a system to identify future needs for facilities, machines and operations?
27.3 There is an established complaint investigation and response program
27.4 Do you have a recovery procedure?
27.5 Do you make simulated withdrawals? At what frequency? Have you done one recently? What was the results?
27.6 Do you have a documented stability program?