How One Pharma Facility’s Assessment and FDA Compliance Efforts Succeeded

Assessment and FDA Compliance Efforts

By Charles Spillman, Senior Consultant

Good Manufacturing PracticesClick here to read Dreading the next FDA inspection? Examine These Six Factors in Your Pharmaceutical Facility’s Process Design and Controls.

We recently worked with a pharma client using DPA’s six-factor assessment tool. The client had received an FDA 483 Inspectional Observations report, detailing several conditions and findings that put the facility at risk of more severe measures.

First Findings
Our initial assessment of the facility found a number of problems: database errors and deficiencies, work management process and preventive/predictive maintenance (PM/PdM) issues. These ‘red flags’ indicated that the facility was in danger of other, more costly problems in the future.

To get a clear picture of how well the organization was managing its procedures and documentation, the assessment tool used a five-stage response format. Responses were assigned a Likert-scale value and tabulated to provide a numeric score for each of the areas of examination. Based on the assessment and subsequent discussions with site management, our team undertook a wide-based program of process remediation.

A representative response for this client was:

Always Usually Sometimes Occasionally Never
Planners are prepared to do field investigation and prepare appropriately detailed plans for execution of maintenance work X

The primary components of our program for this client included:

  • Walkdown/field verification of assets
  • Construction of the asset hierarchy in the resident CMMS system
  • Corrections/additions to the plant piping and instrumentation diagrams (P&ID’s)
  • Risk assessment for all GMP associated assets
  • Preventive/predictive maintenance (PM/PdM) optimization for all high-value and process-related assets
  • Work management system revision

Diving Deeper
After the above assessments were completed, we designed a data collection tool specific for the facility, then trained staff to use the tool. Staff members were assigned to physically inspect and collect data in different areas of the facility based on each area’s accessibility and order of importance. Some areas were only accessible during shutdown and had to be scheduled around cleaning schedules.

How One Pharma Facility’s Assessment and FDA Compliance Efforts SucceededAs each area was completed, the assets were assigned hierarchy positions based on associated equipment and their placement in the sequence of production operations. Each significant asset (including all instrumentation and control devices) was examined for impact on the process and products. Based on pre-determined criteria, each asset was assigned a risk value. This value was later used to identify the level of PM/PdM support appropriate for the asset.

Covering All Bases
One of the primary concerns in performing the walk-down effort was to standardize the level of detail being gathered in the data collection tool, and to ensure that all of the CMMS data entry was kept current with the field efforts. Omissions and errors in the P&ID’s were noted and referred to site engineering for correction on a system-by-system basis.

The work management process was examined, and in cooperation with site engineering was revised to ensure that all portions of the process were addressed. Specific RACI’s (responsibility, accountability, consulted, informed) matrices and processes were designed and documented for:

  • Work discovery
  • PM/PdM generation
  • Planning
  • Scheduling
  • MRO management, including bag & tag staging
  • Assignment
  • Execution
  • Documentation
  • Close-out
  • Metrics

All of the activities were controlled from within the resident CMMS system.

Improvement Outcomes
The facility’s production has stabilized. Fewer batches are held for inquiries, and there has been a marked reduction in downtime associated with equipment failure. The FDA 483 Inspectional Report has been lifted, and the facility is in a better position to avoid such infractions in the future.

Management and employees embrace a rigorous process for introduction of and documenting new assets in the facility’s process hierarchy. There is a better understanding of roles within the facility, and better cooperation between departments.

Documentation of PM/PdM processes has improved, and standard work plans are being used where needed. The facility is positioned to adapt for the future, and provide safe, reliable products for the market.

Has it been some time since you conducted an assessment of your pharmaceutical facility’s process definitions, controls and procedures related to your critical assets? Concerned about your ability to pass the next FDA inspection? Do you need to onboard new employees in SOPs to remain compliant? Utilizing our comprehensive assessment tool, DPA’s team can help you proactively address issues that put you at risk of FDA action. Call Daniel Penn Associates at 860.232.8577 or email us at info@danielpenn.com


DPA Senior Consultant Charles Spillman, CMRP, CPIM, CSCM, CPMM has thirty years’ experience in consulting and facilities management, with projects ranging from maintenance enhancement to integrated and activity-based costing systems to budgetary control systems to productivity/scheduling improvement programs. He has teaching credentials with the Departments of Navy, Army and Energy, teaching reliability practices, change management and management for engineers.

He serves a number of sectors: military and industrial, pharmaceutical, refining and petrochemicals, pulp and paper, primary metals, mining, food service, engineering, automotive stamping and assembly, software development, clerical, distribution and custom fabrication.

Prior to entering consulting, Spillman taught Business Administration at the University of Kentucky and continues as a visiting lecturer when time permits.