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Gary Spies
Director/Team Leader EHS and Site Services, Pfizer Global Supply (PGS) Kalamazoo
Dermot Dolan
Director EHS Systems and Audit, Pfizer Global EHS
NAEM 2014 Advancing Compliance Assurance and EHS Management Systems Conference, August 2014
Pfizer – Our Business
Pfizer Inc: Working Together for a Healthier World®
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human biologic and small molecule medicines and vaccines, as well as many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time
Overview of Kalamazoo Site and Operations
Active Ingredient and Injectable Finished Forms
3,000,000 ft
2, >30 buildings, 2000 acres
~3,000 employees and contractors
VPP Star and Wildlife Habitat Council Certified Site
EHS Staff of 42
– Air, Water, Waste
– PSM, IH, Safety
– Emergency Prep
Pfizer EHS Audit
Our Vision
Pfizer EHS Audit will be seen as a ‘Value Added Auditing’ function that will assist sites continually improve their EHS performance and risk control programs through thorough
and welcomed assessments of their EHS management system.
Our Purpose
To provide an objective assessment of the adequacy of the management of EHS risk at the site level.
Our Scope
• To verify internal site compliance with all applicable Pfizer EHS Standards, Pfizer Corporate Procedure on Business Continuity Management (BCM) and all applicable EHS regulatory requirements.
• The Pfizer EHS Audit Program design is intended to match the broad requirements of the Board of Environmental, Health and Safety Auditor Certifications (BEAC) Performance and Program
Standards for the Professional Practice of Environmental, Health and Safety Auditing and the Institute of Internal Auditors International Professional Practices Framework (IPPF).
• Pfizer EHS audits are not typically performed under Attorney-Client Privilege.
• At Pfizer we have a shared understanding that an audit, while extremely useful, is still a snapshot in time and we are building a culture of compliance in everything we do.
Audit Team 44% Network 48% Consultants 8% 2014 Audit Team 52% Network 24% Consultants 24% 2009 2009 2014
Audit Organization* 4 Auditors + Program Lead + Coordinator 2.5 Auditors** + Coordinator
Average Audit Team Size 3.5 2.5
Number of Audits 34 32
Pfizer EHS Audit
Changes to EHS
Audit team
makeup
* Note: Pfizer EHS Audit reports to the VP of Global EHS ** Note: Includes Program lead
Network = internal
site and center based technical staff
EHS AUDIT – IMPROVEMENTS
Pfizer EHS Audit underwent changes in reporting relationship and team structure through 2009 and 2010. The following changes were implemented through the transition:
Development of new Vision and Purpose for EHS Audit which guided a change in audit culture Focus on utilization of the internal network experts to undertake audits (increased use of Guest
Auditors)
– Streamlined training to enable Guest Auditors use their technical skills in an audit setting. – Modified responsibilities for Audit Team Leaders (they are fully accountable for directing
Guest Auditors on-site)
Embedding audit within Global EHS risk management systems:
– Audit now a key input on EHS enterprise risk management processes (utilizing audit data to inform overall program performance and audit team leader professional judgement on site EHS management)
– Using output of these processes to determine site audit schedule and scope. This includes identification of targeted audits (e.g. Process safety management; baseline audits for new acquisitions).
– Leveraging compliance reporting systems to effectively report outputs of EHS audit to management
EHS AUDIT – IMPROVEMENTS
Consistency in audits driven through:
– Strong mentoring
– Strong linkage to technical Pfizer SMEs and Legal to ensure correct interpretation. Ensuring we have technically competent colleagues on audit teams to match the selected audit
priorities.
– Team ‘Information sharing’ sessions (using specific audit examples to drive learning)
– Comprehensive audit report review process (incorporating Pfizer technical SMEs, legal and ultimately the program leader who reviews/approves all reports).
Audit team leader accountable for approving action plans and reviewing and
approving evidence to support closure of action plans
– Increased use of verification audits
– Recent focus on utilization of root cause evaluation tools to assure audit action plans include effective corrective and preventative action plans.
Mixed results when comes to use of software. Self developed audit tool (based off
SharePoint) now being changed and moving to another system (joint project with all principle audit functions in Pfizer)
Stated purpose regarding development for audit team leaders – “Audit will be a
function in which EHS professionals seek to work to apply existing knowledge to new situations and to learn additional knowledge and skills. Time as an EHS Auditor will become a desired step in the career development of EHS professionals”.
EHS AUDIT – OUTCOMES
Continued use of Audit and the Guest Auditor program to enable colleague
development;
The Guest Auditor program is seen to have a key role strengthening EHS network
sharing;
Increased focus on EHS risk has allowed reduction of audit burden (days on site and
audit team members).
– Challenge is to assure audit remains effective in identifying known and, particularly
unknown risks. This is mitigated through greater pre-audit scope evaluation and trusted and open consultation with sites and applicable center colleagues related to site risks. This allows prioritization of audit topics for each audit.
– Challenge in incorporating new risk areas (e.g. Business Continuity) while maintaining focus on traditional risk areas. This is mitigated again through greater pre-audit scope evaluation.
The focus on effective action plans has resulted in audit findings being addressed
EHS AUDIT – KEY CONCLUSIONS
1. Per the Purpose, outcomes from audits have demonstrated that the program is successful in evaluating site EHS risk including the management systems in place to support regulatory compliance.
2. The culture associated with EHS audit has shifted. The Vision for the program is being realized on every audit conducted whereby thorough audits are being completed within a collaborative and learning environment.
3. Pfizer EHS audit is having an impact on EHS performance. Although not directly measurable, there are many cases where audit has identified matters that have driven continuous improvement in global EHS programs.
