Full PSCI SAQAudit Report Template.docx

1、Full PSCI SAQ Audit Report TemplatePharmaceutical Supply Chain Initiative (PSCI)Self-Assessment Questionnaire and Audit Report for Pharmaceutical Industry SuppliersAPI, Dosage Formulation, Chemicals and Intermediate Chemical ManufacturersGUIDANCE FOR COMPLETIONSections marked in orange need to be fi

2、lled in by the supplier before the audit. Sections marked in grey will be filled by the audit team during / after the onsite audit. Please do not change the report format and do not change the answers given by the other party. Supplier and auditors are asked to complete all questions that apply. If

3、a question does not apply, please mark it NA (Not Applicable). We would expect the following types of suppliers to complete all the questions: API, Dosage Formulation, Chemicals and Intermediate Chemical Manufacturers.AUDITOR AND AUDIT REPORT INFORMATIONReport Number:Report Owner:Note: this is the c

4、ompany paying for /sponsoring the audit. If a PSCI Member, the name should be removed before the report is uploaded to the PSCI audit sharing platformDate of Audit: DD/MM/YYYY initial follow up other, please specify Date and Type of Previous Audit(if applicable): DD/MM/YYYY initial follow up other,

5、please specify Audit Firm Name:Lead Auditor Name:Title:Names of further auditors:Title:Phone Number:Email Address:FACILITY DETAILSCompany Name:Site Name (if different): Parent Company Name (if applicable):Site Street Address:Site City:Site State/Province/County:Site Postal/Zip Code:Site Country:SITE

6、 CONTACT INFORMATIONSite Representative Name (host):Title:Phone Number:Email Address:Management Representative Name:Title:HSE(Health, Safety, Environmental Protection) Representative Name:Title:HR (Human Resources) Representative Name:Title:EXECUTIVE SUMMARYOverall findings Please check applicable b

7、ox(es) and indicate the number of findingsCriticalNumber of CriticalsOtherNumber of OthersNoneA Management SystemsBEthicsCLabor DEnvironmental ProtectionEHealth & Safety Compliance and Risk ManagementIt is not possible in an audit, with a limited time frame, to identify every area requiring attentio

8、n. It is the responsibility of the audited party to establish, implement and maintain effective systems and procedures that comply with the regulatory requirements. Due to the size of the site only the most important buildings, facilities, and HSEtopics could be inspected or discussed during the aud

9、it.CriticalFindings: Are very high risk findings that require immediate action to protect human life, the health of employees or the environment; May result in loss of license to operate or serious damage to reputation; Require immediate corrective action by the supplier; Need to be communicated to

10、the audit sponsor prior to audit report finalization.OtherFindings: Are all other major or minor audit findings, which need to be corrected by the supplier in an appropriate period of time.Attitude of workers (towards management, workplace, and the interview process):Note: do not document informatio

11、n that could put the worker at riskAttitude of management (to audit and audit process):Summary of main findings:Facility Background InformationPlease indicate which of the following best describes this facility (check all that apply):API(active pharmaceutical ingredient) manufacture Biological manuf

12、acture Chemical manufacture Contract Research Laboratories Finished Formulations Logistics / WarehousePrimary Packaging Other (please describe)Comments: Is the facility located in a region that has experienced any of the following natural disasters in the previous 50 years:Flood Earthquake Damaging

13、windstorm Wildfires Volcanic Activity Tsunami Impact Hurricane/Typhoon Tornado Describe the type of work currently being, or proposed to be performed at this facility (include product types such as antibiotics, solvents):Please describe the facility HSE (Health Safety & Environment) resources (numbe

14、r of staff or time spent on HSE):Please provide a copy of the companys organization chart indicating areas of expertise in HSE and whether they are full time. Please provide qualifications of the full time HSE people.What is the primary language spoken by the majority of the employees at this locati

15、on? Primary language:Other languages (spoken by at least 10% of the workforce):Is company sponsored housing provided to any contract or full time employees working at this location? Yes No If yes, what is the approximate number of workers living in company-provided housing: Number of Employees/Worke

16、rs by Category (Provide data for the entire site. Also, please note that there may be workers/employees who fit into multiple categories and should be accounted for under each applicable category (i.e., there is overlap between categories)MaleFemaleTotal employee population onsite (including tempora

17、ry, part-time and contract workers)Full time employees/workers directly employed by the companyPart-time employees/workers directly employed by the companyIndirect, contract or dispatch employees/workersEmployees/workers under the age of 18Migrant or Foreign WorkersStudent workers (include students,

18、 apprentices and interns)Total Site Area (m2): Manufacturing Area (m 2): Does your company own the facility?Yes No If no, who owns the facility? If the facility is not owned by the parent company, are the following within your operational control?Waste water treatment plant? Yes No Utilities? Yes No

19、 Security? Yes No Management of the roadways? Yes No Indicate if the site is in a rural, industrial, residential or mixed commercial settingRural Industrial Residential Mixed commercial setting Please attach a local area map with water sources if available.When was this site initially constructed? P

20、lease indicate the years of industrial use of the site.MANAGEMENT SYSTEMS Self-Assessment Questionnaire - Questions marked with an asterisk (*) are for information only and should not be considered for potential findings by the auditor.Auditor VerificationPlease provide observations, details, commen

21、ts and any supporting documentsCommitment and Accountability1*Does the facility have any ethics, labor, environment, health and safety management system accreditations, certifications, or awards?OHSAS 18001 Yes NoISO 14001 Yes NoISO 50001 Yes NoSA8000 Yes NoInvestors in people Yes NoOther (e.g. Awar

22、ds, OSHA VPP, EMAS) please list: Yes No Comments2Does management engage employees in open two-way communication?(e.g. Town Hall meetings, employee surveys, management factory rounds, management-employees Q&A sessions)Yes NoPlease explain:Yes No CommentsLegal and Customer Requirements3*Are there any

23、issues related to Ethics, Labor, Environment, Health, and Safety (HSE) Regulatory Compliance?Is there any ongoing litigation or regulatory notices with respect to regulatory compliance? Yes NoAre there any historical major regulatory actions? Yes NoAny continuous / prolonged situations where regulat

24、ory compliance requirements are exceeded (within the past 12 months)? Yes NoPlease explain: Yes No Comments4Does the facility assess ongoing compliance with Health, Safety, and Environment, Business Ethics issues, and Labor regulations?Yes NoPlease explain: Yes No Comments5Does the facility ensure t

25、hat suppliers and service providers operate good practices with regard to the PSCI Principles (i.e., labor, ethics, environment, health &safety, and management systems)Yes No If yes, how? By on-site assessment / audit:Yes NoBy desk-top assessment (e.g. questionnaires):Yes NoPlease explain:Yes No Com

26、ments Risk Management6Does the facility use risk assessment and risk mitigation methodologies to assess and manage business, reputation, and legal risks?Business risks: Yes NoReputation risks: Yes NoLegal risks: Yes NoPlease explain: Yes No Comments 7Does the facility have a process to manage change

27、 control for HSE (e.g. raw materials, processes, personnel etc.)? Yes NoPlease explain:Yes No Comments 8Has the facility developed and implemented a site-based Business Continuity Management plan that includes the following elements:Identification of the major facility dependencies that can create b

28、usiness interruption at the site? Yes NoA risk assessment of the identified dependencies and developed a prioritized remediation of those risks? Yes NoPrioritized key supply initiatives and determined the recovery time objective for key production areas? Yes NoPlease explain: Yes No Comments 9Does t

29、he facility have security systems for controlling physical access to the facilities? Yes NoPlease explain: Yes No CommentsDocumentation10Does the facility maintain documentation for key issues?Yes NoDoes this include:Audit findings Injury and Illness Logs Worker Benefits and Pay Information Inspecti

30、ons by Regulatory Agencies Worker Complaints Performance Assessments Documentation of Training Yes No CommentsTraining and Competency11Are workers made aware of policies and procedures, and are they trained accordingly?Yes NoPlease explain how policies and procedures are communicated and implemented: Please describe trainings in each of the following areas:Ethics: Labor: Environment, health & safety: Emergency preparedness/response: Yes No CommentsContinual Improvement12Does the facility perform self-assessments and/or internal audits to improve the effectiveness of its l