Standard Operating Procedure Title: Housekeeping Audit Procedure

Transcription

1 Standard Operating Procedure Title: Housekeeping Audit Procedure Department Quality Management Document no QMS-105 Prepared by: Date: Supersedes: Checked by: Date: Date Issued: Approved by: Date: Review Date: Document Owner Quality Assurance Manager Affected Parties All Quality Assurance Colleagues and production/process teams. Purpose The level of Housekeeping is an indication of someone s attitude towards GMP and Quality. This means: i Thinking SAFETY FIRST. i Thinking GMP COMPLIANCE i Wearing uniform and hairnet correctly. i Minimising the amount of equipment k ept in areas. i Not cluttering areas with unnecessary items or personal belongings. i Emptying bins and removing waste. YOU ARE DIRECTLY RESPONSIBLE FOR GMP IN YOUR AREA Scope To outline the procedures for Housekeeping Audits. Definition DR Housekeeping Auditor Housekeeping Audit Housekeeping Coordinator Deviation Report System A person who is trained to perform Housekeeping audits. A process of checking an area for GMP Compliance A person nominated by the Team, who is responsible for the Housekeeping Coordination role. GMP Related Documents Housekeeping Audit Check Sheets Good Manufacturing Practice Form-425 Analytical Laboratory Form-430 Production Services Form-435 Electrical and Mechanical Workshop Form-440 Warehouse Form-475 Dispensary Form-485 Production EHS-010 Environmental, Health and Safety - Risk Management Ú» Ì ²± ² ±ª»¼ ½± «²» ³»¼ ²»¼ Ú» Ô±½ ±²æ Ü» Ð ²»¼æ Ð ¹» ï ±º îê

2 Standard Operating Procedure Title: Housekeeping Audit Procedure i Calibrations i i i i i Safety. Clothing worn correctly /No jewellery General maintenance of area i.e. chipped or flaking point GMP procedures Environmental, health and safety issues Each area will also have items that are only applicable for that area Housekeeping audits by QA St affs will be conducted in the presence of the Process Manager At the end of the audit any action items will be discussed with the area manager. íò 3.1. There are prepared checklists for the following area to keep record of the audit. Form-425 Analytical Laboratory Form-430 Production Services Form-435 Electrical and Mechanical Workshop Form-440 Warehouse Form-475 Dispensary Form-485 Production 3.2. The Checklists are divided into 3 sections: GMP Items, EHS Items and Area Specific Items All Proc and Support teams should utilise the checklists as specified above for each individual team The Housekeeping Auditor should complete all Sections as indicated in each audit checklist. ìò ß«¼ λ ± ²¹ 4.1. Audit details including action items and general comments are entered in the audit report. Any deviat ion for non compliance a deviation report to be raised and report forwarded to appropriate manager/s It is the responsibility of the area manager concerned to take action to rectify any findings of the audit. DR must be completed within one week of the au dit or a work order submitted. If something has to be made or it is a big job, an action plan must be put into DR follow up tasks to complete the action item. ëò Ý»½µ Ò±²ó½±³ ²½» 5.1. A Deviation Report (DR) will be raised by the Housekeeping Auditor /QA Representative/Process Manager: For GMP non -compliance if a cross (X) is recorded. Comment must be made in the Comments column and a DR rose immediately following the completion of the audit, if the non-compliance cannot be corrected during the same shift as the audit For an EHS non -compliance - immediately following the completion of the a udit, if the non -compliance cannot be corrected during the same shift as the audit. An EHS item is identified and Reported to the EHS team immediately. Ú» Ì ²± ² ±ª»¼ ½± «²» ³»¼ ²»¼ Ú» Ô±½ ±²æ Ü» Ð ²»¼æ Ð ¹» í ±º îê

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12 EHS Workplace Inspection Checklist (Ref. SOP QMS-080) Code for Checklist: O = Observation, i.e. observed during the audit R = Rectified immediately N/A = Not applicable or not observed / not covered at this audit DR = Deviation Report Form-445 Issue Date: Use Risk Assessment Matrix on Page 6 of Inspection Checklist to document and rate identified hazards WORK ENVIRONMENT Is lighting adequate for the tasks completed? Is the noise level too high / hearing protection in place if required? Is appropriate PPE easily available for tasks if required? Is thermal comfort satisfactory? Is the layout of the areas satisfactory? Is there safe access / egress? Are floor surfaces adequate for the tasks completed? Are there dusts / fumes / odours? Is there a confined space within the area? Does it require entry? Is there pallet racking / are they inspected regularly? WORK ORGANISATION Does the workflow look right and allow smooth task completion? Is the right equipment available for the job? What is the rate of work? Does the operator work alone? If so, are there additional communication measures in place? Are jobs rotated regularly? FIRE AND EXPLOSION HAZARDS Are flammable materials used in the area? If so are there adequate precautions / controls? Are there potential sources of ignition within the work area? Are extinguishers in place with appropriate signage & clearly marked for type of fire? Have extinguishers been recently serviced? Do employees know location of extinguishers? Do employees know location of exits and evacuation procedure? Are there adequate direction notices, evacuation maps and signs for Fire Exits? Do exit doors easily open from inside? Are exits clear of obstructions? Are evacuation instructions available and displayed? ELECTRICAL HAZARDS Are there broken plugs, sockets or switches? Are there frayed or damaged or strained leads? File Location: Date Printed: Page 23 of 26

13 EHS Workplace Inspection Checklist (Ref. SOP QMS-080) Are there energy saving practices / equipment in place? Form-445 Issue Date: HAZARDOUS SUBSTANCES Do employees know where to access MSDS? Do employees know how to dispose of used chemicals and containers? Are there sharps / appropriate disposal containers readily Are all containers clearly labelled? Is storage suitable for different chemical types? Are chemicals of incompatible classes stored separately? Are cabinets located more than 3 metres from ignition sources? Is appropriate PPE available and worn by employees? Is there appropriate ventilation? Is there an emergency shower / eye shower? Are they tested? FIRST AID Are employees aware of location of First Aid kits / rooms? Do employees know first aid / emergency procedure? Are cabinets and contents clean, orderly and adequately stocked? SLIP TRIP AND FALL HAZARDS Are surfaces even No cracks, holes, frayed carpet or other trip hazards? Are floor surfaces slippery? Are walkways adequately lit and clearly marked? Are walkways unobstructed? Are stairways fitted with handrails and grip tape if needed? Is there unobstructed vision at intersections, stairs and risers? Is the housekeeping standard good? Is there adequate fall protection for high work? Is work required at heights or in areas with limited / confined space? WASTE HANDLING Are appropriate bins available for various waste types? Is waste separated for recycling where possible? Is waste removed / emptied regularly? EHS MANAGEMENT SYSTEM Are employees aware of EHS policy? Do employees know how to identify and report a EHS hazard? File Location: Date Printed: Page 25 of 26