HOW TO PREPARE FOR A CALARP AUDIT FROM

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
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