FSMS Approved Chemicals Authorized Handlers List Template
All chemicals used for cleaning/sanitation are noted on an Approved Chemicals and Authorized Chemical Handlers list, FS1050-3 APPROVED CHEMICALS/AUTHORIZED HANDLERS LIST EXAMPLE is a sample of this list. The FSMS Approved Chemicals Authorized Handlers List Template covers chemical name, chemical manufacturer, FDA approval code, authorized handler(s), and more.
Persons responsible for applying or mixing chemicals are trained by qualified personnel and are identified on the same list. All chemicals for cleaning and sanitation are suitable for use in food establishments and are approved by the appropriate food safety regulatory agency (i.e., US FDA). Material Safety Data Sheets (MSDS) are kept on-site for all chemicals used in cleaning and sanitation activities.
The company should aim to prevent or eliminate food safety hazards or to minimize the likelihood of food safety hazards being introduced through the work environment; to control biological, chemical, and physical contamination of the product(s), including cross-contamination between products; and to control food safety hazard levels in the product and product processing environment.
FSMS Approved Chemicals Authorized Handlers List Template Details
The FSMS Approved Vendor List Template should be maintained by the Food Safety Team Leader, identifying suppliers who have demonstrated the capability of meeting the company’s quality and food safety requirements. The FS1100-1 APPROVED VENDOR LIST should be organized alphabetically by product or service supplied and cross-referenced by material ID number and vendor name (or ID).
In addition to the product or service identification, the Food Safety Approved Vendor List should include, at a minimum:
Vendor contact information;
Vendor or Contract number;
Vendor Class (see section 2.0);
Vendor’s item ID or part number; and more.
To be listed as an approved vendor, a candidate must provide certain assurances of capability, depending on the nature and seriousness of the potential risks its products or services pose to the quality and safety of the company’s products.
The FSMS Approved Vendor Notification Template should be used to notify the Purchasing Manager, Accounting, and the likely requisitioning department when the Food Safety Team Leader adds a vendor to the approved vendor list. The FS1100-3 APPROVED VENDOR NOTIFICATION covers vendor name, sales contact information, class, registrar, and more.
Before approving a vendor and completing the Food Safety Approved Vendor Notification, prospective vendors should be evaluated using the following criteria:
The vendor’s performance capability (i.e., financial status, sufficient facilities, capability of equipment, and capability/training of employees), ability to fulfill Company requirements, and ability to deliver accurately, completely, and in a timely manner.
Vendors certified to the ISO 22000:2005 standard should be given preference:
When such vendors cannot be found, the Company should give preference to vendors having HACCP-based plans and PRPs in place. The Company should verify the prospective vendor’s HACCP plans and/or PRPs.
A copy of the vendor’s ISO certificate and/or verification of vendor HACCP plans and PRPs should be kept on file.
The assigned audit team leader (Lead Auditor) should prepare the audit plan – using the FSMS Audit Plan Template as a guide at least one month prior to the scheduled audit; the lead time required will vary according to the area being audited and the scope of the audit. The FS1160-2 AUDIT PLAN should include the purpose, scope, criteria, and objectives for the audit, as well as identify audit date(s) and audit team members. (Unless otherwise specified, the criteria will be the requirements of ISO 22000:2005.)
A schedule (agenda) for interviewing department personnel should be provided. (When constructing the audit schedule, the audit team leader should be sure to allow time for auditors to review and clarify notes and meet with other team members for discussion). Any documents required for the audit shall be identified (e.g., purchase orders from January 1 March 31 of the current year). Any operations or maintenance areas to be visited and observed shall be identified. In preparing the Food Safety Audit Plan, the audit team leader should review previous audit reports, corrective action requests (CAR), production histories, complaint files, satisfaction surveys, and any other documents deemed relevant to the audit.
The FSMS Audit Program Template should be used as a guide by the Food Safety Manager (or Food Safety Team Leader) to prepare an annual food safety audit program. The purpose of the FS1160-1 AUDIT PROGRAM is to verify that:
Activities having an effect on the safety of the Company’s product(s) are in compliance with the Company’s Food Safety Management System (FSMS);
The Company’s FSMS complies with the most recent version of the ISO 22000 standard; and
The FSMS is effective in achieving continual improvement of the Company’s products/services.
The Food Safety Manager should have an understanding of audit principles, auditor competence, and the application of auditing techniques, in addition to having knowledge of and experience in the Company’s processes and food safety concepts and techniques. The Food Safety Manager should submit the Food Safety Audit Program to Top Management for review and approval. Upon approval of the Audit Program, the Food Safety Manager should ensure communication of the program to the appropriate parties.
The audit begins with an opening meeting, as indicated in the audit plan. The opening meeting should be attended by all personnel identified in the plan (other department personnel may attend the meeting, at the discretion of the area manager). During the opening meeting, the Lead Auditor (audit team leader) should introduce the audit team and explain the FS1160-1 AUDIT PLAN. Copies of the audit plan are distributed (if they have not been previously) and the schedule is confirmed. Questions from department personnel will be answered to the degree the team is able to do so. If there are any special (e.g., safety) concerns with the area to be audited, it is the responsibility of the area manager to review any special requirements with the audit team.
A final audit report should be prepared using the FSMS Audit Report Example Template as a guide, documenting in detail the findings presented during the closing meeting. In addition to the items covered during that meeting, the Food Safety Audit Report will include each of the nonconformity reports generated during the audit, a brief description of any obstacles encountered, a statement of the confidential nature of the contents, and an appendix containing the audit plan and any checklists used and notes generated during the audit. When the FS1160-4 EXAMPLE FINAL AUDIT REPORT is complete and available, it is distributed as directed by Top Management.
At a time agreed to by the audit team leader and the manager of the audited department/area/process, the audit team will conduct a follow-up visit, to verify the actions taken as a result of the audit. At the time of the follow-up, the manager of the audited area should demonstrate that actions required by the audit have been implemented and are effective.
The internal audit process should be validated periodically (annually, at a minimum) through an audit. During this validation, evidence will be gathered and evaluated to determine if the internal audit process has been effectively implemented and is producing the desired results. Any nonconformity found in the internal audit process by this validation effort should be considered major, since the internal audit process is the primary means of assessing the effectiveness of the FSMS.
The FSMS Calibration Database Template should be used as a guide by the The Quality Assurance Department to retain calibration records for the period required by law. Calibration records should be maintained in a secure file or Food Safety Calibration Database. Calibration may be performed in-house or contracted out to a third party that has been evaluated to ensure that it complies with or exceeds the requirements set forth in ANSI/NCSL Z540. Standards used to calibrate equipment must be traceable to the National Institute of Standards and Technology (NIST) or other recognized national or international standards. If no such standards exist, the basis used for calibration of verification should be recorded.
Specific written calibration instructions are used for each piece of equipment or family of equipment. Procedure should include the following requirements as appropriate for the device:
The calibration should be done by comparison to working standards traceable to NIST with an accuracy of 4 to 10 times greater than that of the measuring tool being calibrated.
The comparisons should be made at several points across the complete range of use of the device, to ensure linearity.
If in-house standards are used by a contractor to calibrate device-related measuring equipment, these standards must be documented, used, and maintained the same as other standards. The Quality Assurance Manager should periodically review FS1140-1 CALIBRATION RECORDS, FS1140-2 CALIBRATION DATABASE, and other information pertinent to the calibration process and report its findings and observations to Food Safety Management for review. Such reviews should occur annually, at a minimum. Food Safety and the Quality Assurance Manager should review the process to determine if is being properly implemented and continues to meet requirements.
The FSMS Calibration Record Template should be used by the Quality Assurance Department to document calibrations and maintain records pertaining to calibration, repeatability, and reproducibility of data. Each FS1140-1 CALIBRATION RECORD should include, at a minimum, a unique equipment identifier (e.g., equipment name and ID), calibration date, method, standards used, condition of equipment as received, any adjustments or repairs required, calibration measurement data, and identification of the person performing the calibration. The Quality Assurance Department should retain calibration records for the period required by law. Calibration records should be maintained in a secure file or database (use FS1140-2 CALIBRATION DATABASE as a guide).
It is the responsibility of everyone using the measuring and test equipment to alert the Quality Assurance Department in the event of accidental damage or any irregularities between calibrations. Where possible, monitoring and measuring equipment is protected from any adjustments which would invalidate the calibration setting by placing the calibration sticker or a dot of tamper paint where disturbance of the sticker or paint would indicate tampering. Where test software is used as a form of inspection or testing, it will be checked to prove it is capable of performing the required verification of product acceptability. It will be rechecked at prescribed intervals. Records of the initial check and scheduled rechecks will be maintained in the Food Safety Calibration Record.
The FSMS Corrective Action Log Template should be used to track corrective action requests. The Food Safety Team Leader should maintain the FS1170-3 CORRECTIVE ACTION LOG, tracking the status of the Corrective Action Request on the log. Every CAR must include a description of the problem, observation, or nonconformance, as well as when and where it was observed. Any employee may initiate a corrective action. Furthermore, it is every employee’s duty to initiate a corrective action when it appears to them that safety of the Company’s end product(s) could be compromised.
In addition to tracking the CAR on the Food Safety Corrective Action Log, The Food Safety Team Leader should forward the CAR to the manager of the responsible department, who should identify a person responsible for investigating and/or taking the necessary actions to correct and prevent the recurrence of the problem. The Department Manager should notify the FSTL of the assignment, and the FSTL should identify the individual responsible for the investigation on the Corrective Action Request form. The Food Safety Team Leader should provide one copy of the Corrective Action Request form to the individual responsible for the action or determination of the action.
When it is determined that a correction or corrective action is required, such action should begin with a FSMS Corrective Action Request Template. Every CAR must include a description of the problem, observation, or nonconformance, as well as when and where it was observed. The Food Safety Team Leader should forward the FS1170-2 CORRECTIVE ACTION REQUEST to the manager of the responsible department, who should identify a person responsible for investigating and/or taking the necessary actions to correct and prevent the recurrence of the problem. The Department Manager should notify the FSTL of the assignment, and the FSTL should identify the individual responsible for the investigation on the Food Safety Corrective Action Request form. The Food Safety Team Leader should provide one copy of the Corrective Action Request form to the individual responsible for the action or determination of the action. The FSTL should keep a copy of the FS1170-2 in the Open Corrective Action file.
The assigned person should investigate the problem to determine the underlying, or root, cause or causes. The person(s) investigating should record any observations, measurements, and the results of this investigation on the FS1170-2 CORRECTIVE ACTION REQUEST. In the event that the Department Manager assigns responsibility for implementing corrections and corrective actions to a specific individual, the Food Safety Team Leader will record the name of the person and the target date for completion on the FS1170-2 CORRECTIVE ACTION REQUEST. Recommendations for changes to a PRP or the HACCP plan should be recorded in the appropriate section of FS1170-2 CORRECTIVE ACTION REQUEST. Upon completion, the person responsible for completing the actions will sign the FS1170-2 CORRECTIVE ACTION REQUEST and return it to the Food Safety Team Leader for review.
The Food Safety Team Leader will review the corrective actions taken and determine the appropriate follow-up or verification required. The verification will be briefly described in the verification of implementation section of FS1170-2 CORRECTIVE ACTION REQUEST. If it is determined that the actions taken are not effective, a new FS1170-2 CORRECTIVE ACTION REQUEST will be generated and the new FS1170-2 will be referenced in the Verification of Implementation section of the previous FS1170-2.
The FSMS Document Change Control Template covers part number, description of change, action codes, and more. If the document review team approves the requested changes, the Food Safety Team Leader should assign a Document Change Number (DCN) on FS1000-2 DOCUMENT CHANGE CONTROL and submit the new or changed documents to Document Control for typing and formatting. Document Control should update the document, index the revision, update the document status on the Food Safety Document Change Control form, and update the revision history on the document.
Document Control should notify the document review team via e-mail when the revised document is available for a “final” review. Reviewers should indicate intended approval or submit comments via e-mail. If comments are substantive, Document Control should incorporate the comments and contact the document review team for another review. When all document review team members indicate their intent to approve, Document Control should circulate the final document(s) to obtain signatures. When the required signatures have been obtained, Document Control should update FS1000-2 with the new revision number and revision date for changed documents, or with all required information for new documents.
The FSMS Document Control Database Template keeps track of document number and title, rev number, rev date, and more. Document Control should make sufficient copies for distribution to all locations indicated on FS1000-3 DOCUMENT CONTROL DATABASE. Document Control should stamp “Controlled Copy” in red on each paper copy before distributing. The master copy of the previous revision should be pulled, marked “Obsolete”, and filed in the historical files (archives). Because the electronic version will not show signatures, the current Master Copy is maintained as evidence of review and approval.
Document Control should use the Food Safety Document Control Database to maintain all controlled documents. Documents of internal origin and external origin (e.g., customer drawings, national or international standards that may be used or referenced) should be maintained in separate lists or databases. External documents are controlled only for distribution. All external standards should be purchased through Document Control, to ensure they are added to the External Document list and are properly controlled and distributed.
Activities conducted in the course of responding to an actual emergency or testing the emergency response plan should be recorded in the FSMS Emergency Response Activity Log Template. FS1200-3 EMERGENCY RESPONSE ACTIVITY LOG covers the date, location, team leader, activity/request, disposition, and more. The Food Safety Team Leader should maintain any logs related to food safety emergency response or testing.
During an emergency, an FSMS Emergency Response Activity Log Template should be initiated and maintained if at all possible. Within two weeks of the emergency, the Emergency Management Directors should review all FS1200-3 EMERGENCY RESPONSE ACTIVITY LOG with the Food Safety Team Leader, to determine if the emergency response plan was adequate or if it requires revision. Any modification to the plan should be tested at the earliest possible date to ensure its adequacy.
Results of quarterly drills will be recorded on the activity log. This log should be completed in a chronological sequence of events. Keep in mind that emergency situations include external and internal causes, both accidental and deliberate. Top management should establish, implement and maintain procedures to manage potential emergency situations and accidents that can impact food safety and which are relevant to the organization in the food chain.
The FSMS Emergency Response Plan Template helps define the methods for effectively planning for, and acting during, emergencies that actually or potentially impact food safety and other company operations. The following information should be incorporated into the FS1200-2 EMERGENCY RESPONSE PLAN:
Emergency services contact information and protocols;
Emergency phone numbers, report forms, and emergency instructions;
Description of emergency warning devices and signals, such as sirens, air horns, and alarm lights;
Facility evacuation plans, assembly points, and rosters of employees assigned to each assembly point; and more,
During an emergency, the company should activate the FSMS Emergency Response Plan Template and assist in controlling the impact of the emergency on employees, visitors, and other employees and company property. Within two weeks of the emergency, the Emergency Management Directors should determine if the Emergency Response Plan was adequate or if it requires revision.
Any modification to the Plan should be tested at the earliest possible date to ensure its adequacy. The Emergency Management Directors will conduct quarterly drills to test various aspects of the FS1200-2 EMERGENCY RESPONSE PLAN. Test activity will include both scheduled and unannounced drills.
The Food Safety Team Leader should prepare a FSMS Flow Diagram Template for each product or process category covered by the FSMS. FS1060-1 FLOW DIAGRAM EXAMPLE is a sample flow diagram for a seafood products company, showing the process steps in order. Flow diagrams provide a basis for evaluating any possible occurrence, increase, or introduction of food safety hazards. Flow diagrams should be clear, accurate, and sufficiently detailed and should include the following, as appropriate:
The sequence and interaction of all steps in the operation;
Any outsourced processes and subcontracted work;
Where raw materials, ingredients, and intermediate products enter the flow;
Where rework and recycling take place; and
Where end products, intermediate products, by-products, and waste are released or removed.
Hazard analysis is the process of collecting and evaluating information on hazards associated with a food ingredient/product, to determine which hazards are significant and must be addressed in the HACCP plan. Hazard analysis consists of two steps, identification and evaluation. By ensuring accurate, thorough, and effective hazard analyses, the company is better able to guarantee the safety and efficacy of food products and/or ingredients under its control and ensure that its products conform to customer and statutory/regulatory requirements.
The FSMS Food Recall Checklist Template should be used when carrying out a food recall. FS1190-1 FOOD RECALL CHECKLIST identifies responsibilities at the administrative (Part 1) and operational site level (Part 2). The checklist should be completed with the name of the person responsible and the completion date for each task.
The Food Safety Team Leader will initiate a product recall when a nonconformity having potential food safety consequences is identified. Such nonconformity may be identified through internal control measures, customer complaints, or regulatory requests. The Food Safety Team Leader should ensure that recalled product can be located, supervise any inventory counts, and account for all recalled food. Logs and other records related to product recalls should be audited (annually, at a minimum), to determine if recall procedures are being properly implemented and continue to meet statutory/regulatory requirements.