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

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).

STEPS TO TAKE AFTER TASKS COMPLETED:

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.

28 Developed by: Lucy Valdovinos Date: 11/14/2013

Phone: 209-559-7595