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

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