Title Page
-
Conducted on
-
Prepared by
-
Location
Prerequisite Program
Management Commitment
-
Senior management ensures that the responsibilities and authorities are defined and communicated within the company
Internal Communication
-
There is a clear communication and reporting channel between senior management and personnel.
Management Review
-
Management review includes: <br>o audit results<br>o customer feedback<br>o process performance and product conformity <br>o status of preventive and corrective action<br>o follow-up action from previous management reviews<br>o planned changes that could affect the quality system<br>o recommendations for improvement
Quality Manual
-
A quality manual with appropriate processes and procedures exists
Control of Documents
-
Document control procedures are in place including approval for adequacy prior to use, updates, and re-approval, identification of the current version, availability, legibility
-
Records are controlled (identifies which records are needed and how long they are kept)
-
The following records are maintained as appropriate to the product (e.g. GMPs, HAACPEuropa.com production records, master record file)
Internal audit
-
Internal audits are performed on scheduled intervals to assess the effectiveness of the QMS
-
Personnel identified and trained to perform internal audits
-
Documentation that corrective and preventive actions were performed as an outcome of the internal audit
Site standards
-
Procedures exist for the review and evaluation of food safety hazards in the event of new or changed facilities
-
Buildings and grounds are adequately and routinely maintained
-
Buildings are maintained in a reasonably clean and orderly manner
-
Buildings are of suitable construction to minimize access to rodents, birds, and other pests
-
Buildings provide adequate space and lighting
-
All equipment maintained in a reasonably and orderly manner
-
All equipment are of suitable size, design, construction, precision, and accuracy for its intended use
-
All equipment is maintained to prevent lubricants and coolants introduction as unsafe additives to food
-
All equipment designed, constructed, and maintained to facilitate inspection and use of cleanout procedures
-
Work areas and equipment used for the manufacture and storage of food are kept separate from chemicals
-
All equipment is properly cleaned to prevent unsafe contamination of food
-
There are procedures in place controlling calibration of equipment
-
There is a master sheet of all equipments
Purchasing
-
Evidence that ingredient specifications are provided to suppliers exists
-
Traceability procedures exist to facilitate product recall
-
Established inspection procedures or other inspection activities to ensure that purchased material specifications are in place, including contamination
Control of production
-
Master record file is maintained for each product which includes product specifications, formulation, label, and special manufacturing instructions
-
Frequency and number of samples needed during production for each batch
-
Proper identification and date of manufacture are provided
-
Production records are maintained that provide formulation, date of production, date of shipment to facilitate recall procedures
-
Work instructions for proper manufacturing procedures are available to personnel
-
Production records are inspected for accuracy at scheduled intervals
-
Equipment is suitable for manufacturing of product to specification
-
Monitoring devices are available and used
Validation of production process
-
Validation procedures are in place and conform to science-based performance standards
Identification and traceability
-
The finished product is properly packaged and labeled for identification and should include name, product description, net weight (or bulk statement), lot number, <br>shelf life date, and all label regulatory requirements
-
Procedures for product traceability are documented
-
Retained samples are identified for traceability (shelf life)
Control of monitoring and measuring devices
-
Monitoring and measuring devices used to manufacture product is properly maintained, calibrated, and recorded
-
Instrumentation and devices used to calibrate monitoring and measuring devices are verified at specified intervals against
Monitoring and measurement of processes
-
Monitoring procedures have been established to evaluate the manufacturing processes, where appropriate
-
Scheduled monitoring activities have been established.
Scheduled monitoring activities have been established.
-
Procedures are in place to ensure product conforms to requirement
Storage of Product
-
Products are properly identified, stored, handled, and controlled to maintain their identity and integrity
Customer satisfaction
-
Procedures for recording and evaluating complaints exist.
Control of non-conforming product
-
Procedures to control non-conforming product have been established
-
Non-conforming product is properly identified and stored in specified location
-
Documentation of final disposition of non-conforming product, which may include rework and re-verification
-
Procedures have been established for product recall or customer notification if non-conforming product is detected after delivery
-
Procedures to handle returned goods are established
-
Documented procedures that establish requirements for reviewing and preventing non-conformities including customer complaints, determine the reason for nonconformity, take action to prevent reoccurrence of nonconformity, records of results of actions taken, and reviewing corrective action taken
Training
-
Records are available that demonstrate personnel competence and training
-
Job descriptions are available that include the responsibility and skills required by the employee
-
Personnel are properly trained in personal hygiene where appropriate to avoid contamination
-
Training matrix is in place
-
Re-freshing training procedure is in place
-
Training records are available for personnel dealing with CCPs.
HACCP
-
The HACCP team has been trained and the training has been recorded<br>a) Include names of the HACCP team and training/job experience which qualifies the individuals in the application of HACCP principles<br>b) The individual developing the hazard analysis, including delineating control measures successfully completed training in the application of HACCP principles. <br>c) The individual developing a HACCP plan that is appropriate for a specific site successfully completed training in the application of HACCP principles. <br>d) The individual verifying and modifying the HACCP plan successfully completed training in the application of HACCP principles.<br>e) The individual performing the record review successfully completed training in the application of HACCP principles.
-
The HACCP plan is specific to the location and site
-
The HACCP plan is specific to the ingredient, food or process
-
If ingredients, food or processes are grouped together in a single plan, evidence exists that they share common hazards
-
The hazard analysis lists all hazards<br>a) The written hazard analysis (which may be in table form) identifies hazards for each process step or includes the statement “none identified at this time” <br>b) The written hazard evaluation is science-based, considers hazard frequency and severity and has been performed for every identified hazard. <br>c) The control measures for significant hazards have been identified.HAACPEuropa.com<br>d) Prerequisite programs exist for significant hazards and are correctly referenced in the HACCP plan<br>e) The hazard analysis procedure included an evaluation of SOPs and modifications were performed if necessary<br>f) Critical control points exist for significant hazards<br>g) The hazard analysis considers external and internal hazards<br>h) Evidence exist that the HACCP team considered, as a minimum, biological, chemical and physical hazards listed in this section.<br>i) The hazard analysis considered possible sources of adulteration including all process steps including packaging, storage, transportation, intended use, facility and equipment function and design, and plant sanitation including human hygiene.
-
All identified hazards are evaluated for their significance
-
CCPs are assigned for significant hazards
-
If applicable to process flow and hazard evaluation, CCPs are assigned for significant hazards outside the site
-
Critical limits are identified for each CCP
-
Procedures exist for monitoring each CCP
-
Monitoring frequency ensures adherence to the critical limit
-
The HACCP plan includes corrective action plans developed <br>a) The corrective action plan describes steps to be taken and assigns responsibility in response to deviations from the critical limits and:<br>o ensures the adulterated product is not distributed or used after the deviation has been identified and before the corrective action has been taken<br>o corrects the deviation<br>b) For deviations that occurs and the site doesn’t have a corrective action plan products is segregated and held, tested for acceptability, not used until the product is brought into conformance with HACCP plan.HAACPEuropa.com<br>c) For deviations that occurs and the site doesn’t have a corrective action plan the cause for the deviation is corrected and verified by a trained individual to determine whether HACCP plan requires modification.<br>d) Records provide evidence that corrective action was performed as described in the HACCP plan
-
The HACCP plan lists validation and verification procedures and their frequency <br>a) Evidence that the site reviews consumer complaints and their relationship to the HACCP plan’s performance or are a new hazard<br>b) Verification that key manufacturing equipment are calibrated according to the plan was performed<br>c) Verification of process monitoring equipment calibration was performed<br>d) Verification that the site performs end-product testing if included in the HACCP plan<br>e) Verification (within 7 days) that critical control point monitoring records were completed, signed and documented values were within the critical limits<br>f) Verification (within 7 days) that calibration records for equipment and processing monitoring were performed in accordance with the HACCP plan<br>g) Procedures outlined in the section were followed whenever any verification activity establishes the need for corrective actions<br>h) Validation procedures were conducted at specified time intervals and after process modifications by individuals trained and recorded <br>i) Whenever no significant hazards have been identified, a reassessment of the hazard analysis adequacy will be performed annually or after process modification by individuals trained and recorded
-
The HACCP plan includes a recordkeeping system for monitoring CCPs <br>a) Written hazard analysis in place that has identified all significant HAACPEuropa.com biological, chemical, and physical hazards<br>b) Written HACCP plan for this location for each type of ingredient<br>c) Monitoring of critical control points and their critical limits<br>d) Calibration of key manufacturing equipment<br>e) Calibration of processing monitory instruments<br>f) Corrective actions including disposition<br>g) Records documenting verification and validation of the HACCP plan<br>h) Records are signed and dated by the most responsible person at the site (acceptance, modifications, verification, and validation)<br>i) All records include the name and location<br>j) All records include the date and time of records created <br>k) All records include the signature or initials of the person performing the operation or creating the record<br>l) All records include the identity of the product and if required the production code<br>m) All records include processing observations and other information entered at the time observed.<br>n) Records required are retained for at least 3 years after the date of production (electronic records are acceptable)<br>o) Records required are available for review and copying during the certification audit
Sign Off
-
Name and Signature
