| Department | Quality Management | Document no | QMS-105 | ||
| Title | House Keeping Audit Procedure | ||||
| 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:
a. Thinking SAFETY FIRST.
b. Thinking GMP COMPLIANCE
c. Wearing uniform and hairnet correctly.
d. Minimizing the amount of equipment kept in areas.
e. Not cluttering areas with unnecessary items or personal belongings.
f. Emptying bins and removing waste.
YOU ARE DIRECTLY RESPONSIBLE FOR GMP IN YOUR AREA
Scope
To outline the procedures for Housekeeping Audits.
Definition
| DR | Deviation Report System |
| Housekeeping Auditor | A person who is trained to perform Housekeeping audits. |
| Housekeeping Audit | A process of checking an area for GMP Compliance |
| Housekeeping Coordinator | A person nominated by the Team, who is responsible for the Housekeeping Coordination role. |
| GMP | Good Manufacturing Practice |
Related Documents
Housekeeping Audit Check Sheets | 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 |
| QMS-015 | Quality Documentation Management and Change Control |
| QMS-035 | Deviation Report System |
| MAN-055 | Procedures for Line Clearance, Line Opening and Line Cleaning |
| QMS-080 | Audits |
EHS Statement
Non-compliances will be to addressed via the DR system, (see SOP QMS-035)
Procedure
1. Introduction
1.1. There are nominated process and support teams responsible for completing Housekeeping Audits.
1.2. The Housekeeping Auditor should follow the audit roster and the teams are to ensure that all production lines and shifts have been audited within the month.
1.3. The Housekeeping Auditor will ensure that a roster is sent to the QA Staffs assigned for the areas at the beginning of each roster period.
1.4. Any statement that no longer applies must be removed and replaced with an alternate statement by following the procedures set out in SOP QMS-015 for updating documents.
2. Housekeeping Audit Procedure
2.1. QA Staffs with the Process Manager conduct monthly housekeeping audits. A QA representative will hence audit each of the production areas each month.
2.2. The schedule and location of these audits will be arranged monthly between the QA representative and Process Manager. QA housekeeping audits may be performed in lieu of, or in addition to, an audit by the Process line housekeeper.
2.3. The audit should last approximately half to one hour and will cover the following items:
a. Cleanliness of area including floors and walls
b. Tidiness of area (no rubbish left around)
c. Labelling/ Expiry date
d. Status labels
e. Calibrations
f. Safety.
g. Clothing worn correctly/No jewellery
h. General maintenance of area i.e. chipped or flaking point
i. GMP procedures
j. Environmental, health and safety issues
k. Each area will also have items that are only applicable for that area.
2.4. Housekeeping audits by QA Staffs will be conducted in the presence of the Process Manager.
2.5. At the end of the audit any action items will be discussed with the area manager.
3. Checklists
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.
3.3. All Process and Support teams should utilize the checklists as specified above for each individual team.
3.4. The Housekeeping Auditor should complete all Sections as indicated in each audit checklist.
4. Audit Reporting
4.1. Audit details including action items and general comments are entered in the audit report. Any deviation for non compliance a deviation report to be raised and report forwarded to appropriate manager/s.
4.2. 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 audit 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.
5. Non-compliances
5.1. A Deviation Report (DR) will be raised by the Housekeeping Auditor/QA Representative/Process Manager:
5.1.1. 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.
5.1.2. For an EHS non-compliance – immediately following the completion of the audit, 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.
6. Training
The GMP Education modules cover the role of housekeeping in GMP. All senior operators and Process Managers who attend these modules are responsible for ensuring their team know how to conduct housekeeping audits.
Summary of Changes
| Version # | Revision History |
| QMS-105 | New |