HOW TO PREPARE FOR A CALARP AUDIT FROM AN INDUSTRY POINT OF VIEW ADVANCED PLANNING: Planning for an inspection in adavnce: Makes an inspection go smoother Allows you to be in control of the inspection Creates a positive impression on an inspection Results in fewer violations Developed by: Lucy Valdovinos Date: 11/14/2013 MONITORING COMPANY’S ACTIVITIES RMP/PSM/CalARP COORDINATOR: Keep up to date and in compliance with regulations. Have local CUPA Regulator’s contact information. NEVER be afraid to ask local CUPA inspector a question. Local CUPA inspectors are a great source to keep abreast of regulations. Maintain contacts with local company RMP/PSM/CalARP Representatives, they are also a great source. Remember they are also going through the same inspections as yourself. CALLING: Beronia Beniamine PREPLANNING The most important step a company can take to get ready for an inspection is to prepare ahead of time. Nothing helps a facility prepare for an inspection like a MOCK INSPECTION. The PSM/RMP/CalARP Coordinator will gather the team that will be involved in the facility inspection. PREPLANNING (Deficiency) FAILURE TO PREPLAN: May suggest that the facility is not actually in compliance. May appear that employees aren't properly trained and/or knowledgeable in their roles and responsibilities. May suggest that the company documentation/recordkeeping isn’t maintained according to regulatory guidelines. PRE-INSPECTION CONFERENCE In general, it is reasonable to request a pre-inspection conference call with inspector(s) to understand the inspection purpose, scope, nature and to provide a facility overview and safety briefing. Spokesperson for the facility should respond to the inspectors questions and document. Spokesperson should also keep track of questions, responses and any follow up questions that require follow-up from the facility. REGULATORY AGENCY CHECKLIST REVIEW Contact your local CUPA Inspector to ensure that you have the latest checklist. It is BETTER to flag tough questions in advance, such as “are the MOC’s (Management of Change) documents and log are updated”, than face this question for the first time during an inspection. PROGRAM EFFECTIVENESS HAVING AN EFFECTIVE PROGRAM IN PLACE IS CRITICAL TO THE INSPECTIONS SUCCESS PREPARING STAFF: From refrigeration technicians to facility management, all facility and emergency response personnel that interact with the inspectors need to be prepared in advance so that they can anticipate and effectively respond to inspectors questions. DEVELOP AN INSPECTION TEAM Every facility should have an inspection team with a standard protocol and plan. The team should receive periodic training on: What the facility can reasonably expect during an inspection; The scope of the inspectors authority; Who will be answering what questions from the inspector, what sections will be answered by who; and The topics typically addressed during an inspection (checklist). MOCK INSPECTION CONDUCTING A MOCK INSPECTION: Will help identify documents required during an inspection. Will ensure that the documents required during an inspection are available and well organized. Will show areas where facility might not be in complete compliance (Who, What, When, Where & How) Will help develop an Action Plan to address deficiencies MOCK INSPECTION (Continued) CONDUCTING A MOCK INSPECTION (WALKTHROUGH): Have the SOP’s in hand with Refrigeration Technician, Supervisor, etc. to ensure that the SOP’s they are using are accurate. Check P&ID’s, Emergency Contact List to ensure that are posted and are current. Check that the piping and valve tags are labeled and that they are labeled appropriately. Check employee PPE lockers to ensure that PPE is properly secure/stored. Check eyewash/shower stations, ensure they are checked weekly (regulatory guidelines). Check fire extinguishers, ensure that they are checked monthly (regulatory guidelines). CHECKING pH Level (Diffusion Tank) AFTER MOCK INSPECTION MOCK INSPECTION RESULTS: Setup a meeting with all team members involved and conduct a debriefing. The goal for this meeting is to identify key findings and to discuss how to address each deficiency. Setup time frame for completing deficiencies and any unresolved issues. Develop an Action Plan to address deficiencies. FOLLOW-UP AFTER MOCK INSPECTION FOLLOW UP QUESTIONS FOR TEAM: Ensure that you do not wait too long to follow-up on tasks listed on ACTION PLAN Address each deficiency with the person responsible for completing the task? If deficiency was not completed why? Ask individuals in charge of completing task if they need assistance? This is not the time for blame, this is the time to fix deficiencies. Always THANK everyone for their help in completing tasks assigned to them. MOCK INSPECTION AFTER COMPLETION OF DEFICIENCIES STEPS TO TAKE AFTER TASKS COMPLETED: Take another walkthrough of the area(s) being inspected, check for housekeeping (fans located in areas where they shouldn’t be, equipment blocking exits, signs missing, etc.) Ensure that team members accompany you during this mock inspection. As soon as this mock inspection is complete meet with the team to go over any deficiencies encountered. If any “new” deficiencies were encountered in this mock inspection follow the same procedures as the initial Mock Inspection (Action Plan, Follow-Up, verify deficiencies were corrected). EMPLOYEE INTERVIEWS Preparing Employees for Interviews Investigators often want to interview employees during an inspection. Employees should know that they can speak with investigators if asked. Employees should understand that they can ask the inspector to clarify if they do not understand the question asked. Employees should feel confident when responding to investigator question(s). What is PSI? What is MI? Where is your EAP or ERP Plan? How do you know how to do you job? Where are the SOP’s? Ensure that employee training records are up-to-date and organized (inspector will ask to see these records). EMPLOYEE INTERVIEWS Preparing Employees for Interviews (Continued) Investigators often want to interview employees during an inspection. Employees should know that they can speak with investigators if asked. Employees should feel confident when responding to investigator question(s). How do you know that you are using the latest procedure? When were you trained on your SOP’s? Who trained you on the SOP’s? When your SOP’s are revised, are you trained on the revisions? How (e.g. formal training, in-house) How long after the revision were you trained? EMPLOYEE INTERVIEWS Preparing Employees for Interviews (Continued) Investigators often want to interview employees during an inspection. Employees should know that they can speak with investigators if asked. Refrigeration maintenance tasks performed by company refrigeration personnel: How do you know when to perform maintenance tasks on the refrigeration equipment? How do you know what maintenance tasks need to be done? What procedures do you use when performing maintenance tasks (i.e. PPE, LOTO)? Do you know what to do in case of an emergency when performing maintenance tasks? EMPLOYEE INTERVIEWS Preparing Employees for Interviews (Continued) Investigators often want to interview employees during an inspection. Employees should know that they can speak with investigators if asked. Other Potential Questions for Refrigeration Personnel How are regulatory requirements communicated to you? What is the effectiveness of the Internal Communication, particularly under a spill or release scenario? How is non-compliance issues communicated to management? Is environmental and safety compliance a factor in job performance evaluations? Does the company have a safety program? What is your role in the Emergency Action/Response Plan? ADDRESS CONCERNS BEFORE INSPECTION Ensure tha the likely areas of concern have been addressed before inspection. ITEMS OF CONCERN DURING AN INVESTIGATION: Not an exhaustive list Adequacy of training documentation Confined Space Training LOTO Training EAP/ERP Training Housekeeping (i.e. equipment in its place when not in use) Compliance with regulations Annual Review of Mechanical Integrity (MI) Annual Review of Standard Operating Procedures (SOP’s) Annual Review of Process Safety Information (PSI) Annual Review of Contractor Qualifications (CQ) Annual Review of Emergency Action Plan (EAP or ERP) Documentation P&ID’s review and updates (if necessary) 3-Year Compliance Audit (with Corrective Actions) 5-Year Mechanical Integrity Audit (with Corrective Actions) Bulletin 109 documents Sensor Calibration Logs ADDRESS CONCERNS BEFORE INSPECTION Ensure tha the likely areas of concern have been addressed before inspection. (Continued) SOME ITEMS OF CONCERN DURING AN INVESTIGATION: Adequacy of training documentation Respirator Fit Test Monthly PPE Equipment Checklist Hazcom Program Training Overview of the process Compliance with regulations Management of Change Documentation & Log Was PSI, P&ID’s, PRV’s, etc. updated because of MOC’s? Were SOP’s revised due to MOC’s? Were maintenance routines reviewed, revised, etc. due to MOC’s? Documentation 5-Year PHA Revalidation 3-Year Offsite Consequence Analysis Parameters 5-Year RMP Resubmittal 5-Year Accident History Log & Reports Pre-Start Up Review (Verification) CalARP INSPECTION – KEY ELEMENTS (RMP Re-Submission) DATA SUPPORTING MOST RECENT RMP SUBMISSION RMP - Resubmission At least every 5-years Within 6-months of a change that alters the Program Level that applies to any covered process Within 6-months of a change that requires a revised off site consequence analysis Within 6-months of a change that requires a revised PHA The date at which a new regulated substance is first present above threshold quantity in an already covered process The date which a regulated substance is first present above a threshold quantity in a new process CalARP INSPECTION – KEY ELEMENTS (5-Year Accident History) 5-YEAR ACCIDENT HISTORY Must Report Accidents That Results In: On site deaths or significant property damage Known off site deaths, injuries, property damage, environmental damage, evacuation or shelter in place Do NOT have to report every reportable release (Our company errs on the side of caution, we document and report incidents to our local CUPA inspector and others to ensure that the company is following the regulation accordingly). CalARP INSPECTION – KEY ELEMENTS (Process Safety Information & Operating Procedures) PROCESS SAFETY INFORMATION & OPERATING PROCEDURES Process Safety Information Is it current? Is it accurate? Does the date of most recent update match RMP submission? Operating Procedures Do you have them? Are they accessible to employees? Are they current? Are they complete for all essential areas? Have they been certified annually? Does date match RMP submission? Have all SOP’s (each one) been signed off by refrigeration technicians responsible for performing the job task(s)? CalARP INSPECTION – KEY ELEMENTS (Emergency Response Program) EMERGENCY RESPONSE PROGRAM ERP Plan Do you have one? Is it current? Does it contain all the required elements? Have employees been trained to the proper level? Documentation of program reviews and updates Local community involvement (Drills with Hazmat) Employee Interviews CalARP INSPECTION – KEY ELEMENTS (Mechanical Integrity) MECHANICAL INTEGRITY POLICY & RECORDS Mechanical Integrity Is program in place and effective? Does documentation of maintenance activity exist? Is there proper training documentation on Maintenance Activities? Has there been a 5-year Mechanical Integrity Audit performed by a qualified, competent and knowledgeable individual? MECHANICAL INTEGRITY AUDIT CONDUCTED WITH REFRIGERATION STAFF CalARP INSPECTION – KEY ELEMENTS (MSDS’s & Previsous Audits) MATERIAL SAFETY DATA SHEET & PREVIOUS COMPLIANCE AUDITS Material Safety Data Sheet Ensure that you have a current MSDS for all chemicals used in the refrigeration department. Are MSDS’s readily available to all employees? Previous Compliance Audit Reports Verify compliance with prior findings. Have all prior findings been closed? If not why? Have prior audit findings been communicated to staff? SAFETY BRIEFING – WHEN INSPECTOR ARRIVES ITEMS TO REVIEW WITH INSPECTOR PRIOR TO CONDUCTING THE WALKTHROUGH OF THE FACILITY: Safety Briefing with Inspector Inspector must ensure that he/she follows all Safety Regulations Inspector must don on and don off PPE that is required when in the facility or when evaluating areas Inform inspector of “rally points” around facility that must be followed in case of an emergency during the inspection Inform inspector that he/she will be accompanied by a company representative at all times (this is for their safety) Food Safety Briefing with Inspector Inspector must review and follow company cGMP’s (Current Good Manufacturing Practices). Inspector is not allowed to wear jewelry or any other item that may pose a contamination risk to products, packaging, environment or employees. Briefing should be brief but long enough to ensure the safety of the inspector and to ensure that he/she follows company regulations. COMPLETING INSPECTION WHAT TO DO WHEN THE CalARP INSPECTION HAS BEEN COMPLETED: What were the results of the inspection? After the inspector reports findings, inspector will determines whether he or she will issue citations and/or propose penalties. What to do when given citation(s)? Citations will be given in writing to the employer (RMP/PSM/CalARP Coordinator) of the regulations and standards alleged to have been violated and of the proposed length of time set to correct alleged hazards. The employer (RMP/PSM/CalARP Coordinator) will receive citations and notices of proposed penalties by certified mail. Employer (RMP/PSM/CalARP Coordinator) should keep in contact with inspector if they have any questions, updates, etc. Always remember that each inspection gives us an OPPORTUNITY to learn what we are doing right and what we are doing wrong. Developed by: Lucy Valdovinos Phone: 209-559-7595 Date: 11/14/2013 28
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