OSHA has cited a pharmaceutical manufacturing facility for 17 serious safety violations following a fire at the company’s manufacturing facility on April 13. The fire occurred during the troubleshooting of an electrical component on the hot oil heater. OSHA initiated an inspection under its national emphasis program on process safety management for covered chemical facilities. Proposed fines total $51,800. Twelve violations cited relate to process safety management and five other violations involve failing to develop machine-specific procedures for locking and tagging out energy sources, perform periodic inspections of machinery, guard machines, require workers to wear insulating gloves and fire-retardant clothing when working on energized circuits, and conduct an arc flash hazard analysis. Here is a break down of the citations…
No written Employee Particpation Plan (Serious; $2,100)
Process Safety Information (Serious; $3,500)
- P&ID issues
- P&ID’s were not developed for the critical utilities such as scrubber, cooling water, steam and nitrogen
- P&ID’s for three (3) vessels did not show the relief devices
- P&ID’s not updated to show the removal of cooling coils on three vessels
- Information outlining the electrical classifications was not compiled
- Information on releief devices was not compiled
- Information on ventilation system was not compiled
- Design codes and standards used was not compiled
- Information regarding the safety systems was not compiled
No documentation that equipment complied with RAGAGEP (Serious; $0)
- No U-1 forms for three ASME pressure vessels
- Glass piping used without adequate evidence it was meeting RAGAGEP
- Scrubber had no RAGAGEP design specifciations
- Boiler used to generate steam for process had no evidence it met a RAGAGEP
- The local exhaust ventilation system had no evidence that it met a RAGAGEP
Process Hazards Analysis (Serious; $3,500)
- The PHA methodology used not one of those listed
- PHA did not address loss of cooling water, loss of electricity, failure of scrubber, occurrence of leaks, failure of alarms and safety devices, failure of the steam system and piping, generation of sulphur dioxide and hydrochloric acid, and outside environmental impacts.
- A system was not established to document PHA recommendations and to track recommendations through a review and resolution process
- Did not re-validate the PHA after 5 years (Serious; $2,100)
Standard Operating Procedures (Serious; $3,500)
- No SOPs for draining aqueous solutions from reactors, bells, water traps and other auxiliary equipment
- NO SOP for putting the reactor under a vacuum
- Bonding and Grounding not incorporated into SOPs
- NO SOPs for charging cooling water and cooling glycol
- No emergency or shutdown procedures in place when process deviated from SOE’s
- No written procedures to address loss of nitrogen, loss of cooling, overloading scrubber, leaks from glass piping, loss of vacuum
- SOPs were not annually certified (Serious; $2,100)
Training (Serious; $3,500)
- Employees operating a covered process were not trained in what PSM is, which processes were covered, and employee responsibilities in PSM
- Employees operating a covered process were last trained in 2007/2008
Mechanical Integrity (Serious; $4,900)
- Inspection of Reactor Vessels did not follow RAGAGEP
- not inspected at the frequency of the manufacturer
- reactor linings had not been spark tested
- reactor linings had not been thickness tested
- agitating nozzles and impingement plates not inspected every 6 months
- steam heating and water cooling jackets not periodically inspected
- Steam piping to the reactors had no fit-for-service inspections or remaining life estimates
- Chilled water system not inspected since 2010
- Glass piping had no fit-for-service inspections or remaining life estimates
- Scrubber only visually inspected since 2010
- Did not correct deficiencies in equipment that were outside(Serious; $3,500)
- free hanging and open ended pipe located above process piping
- pipe end cap held in place with duct tape
- local exhaust ventilation duct work held in place w/ duct tape
- local exhaust ventialtion duct work was pulled away from header duct work
- broken pressure gauge on steam line to jacket
Management of Change (Serious; $2,100)
- MOC procedure did not address the technical basis for the change, impact on S&H, modifications to SOPs, necessary time period for the change, nor authorization requirements for the change
- SOPs were not updated when changes were made to the glycol chiller operation (Serious; $3,500)
Compliance Audits (Serious; $2,100)
- No audit had been conducted on the PSM program
Safe Work Practices (LOTO) (Serious; $3,500)
- No machine specific isolation procedures for scrubber, steam system, hot oil system, cooling water system, Local exhaust ventilation, and other equipment that had more than one power source
- No periodic inspection (Serious; $2,100)
Machine Guarding (Serious; $2,800)
- Agitator shaft on a reactor not guarded
Electrical (Serious; $3,500)
- Electrical pull boxes and junction boxes missing face plates
- Maintenance workers not employing electrical safety related work practices (Serious; $3,500)
- Maintenance workers not employing the use of electrical PPE
CLICK HERE (pdf) for the citations