Wednesday, August 6, 2008

Preparing for an Inspection

July 11th, 2008
Inspections and Audits
First we need to know the difference between an Inspection and an Audit, which is:
An Inspection takes place at a lower level (normally employee or first line supervisor), it is done more frequently (daily, weekly monthly) and is focusing on the detail of all aspects within the working environment, for example: the fire fighter or external fire contractor will inspect all 160 fire extinguishers in the working environment every month.

An Audit is done at a higher management level or externally by a professional/specialist (lawyer or ISO/OHSAS lead auditor), it is done less frequently (once every 3 months or 6 months or annually) and it consist of a process of random sampling (looking at a representative sample), for example: part of the OHSAS18001 audit might consist of looking at emergency preparedness and response and therefore you would audit randomly fire extinguishers 7, 88, 122 & 149 to determine if the implementation of this section was done effectively.
So how do you prepare for an inspection?
Here are the steps in the process:
Determine which area or aspect needs to be inspected.
Identify the competent person who will take ownership of this task.
Identify the inspection form to be used and ensure that the criteria on the form is applicable to the inspection to be carried out and that it is understood by the person that is going to perform the inspection.
Make a decision whether the inspection will be done announced or unannounced.
In both cases inform the respective manager of the area/division of your intent.
Select a day and time for the inspection.
Make sure that the selected day and time is not during lunch, tea-break of shut-down but during a normal busy shift.
On the day of the inspection:
Confirm with the area manager that everything is going according to plan.
Identify possible resources that are needed (eg. PPE requirements, transportation, etc.)
Ensure you have your clipboard, inspection form, writeable pen and other requirements available.
Switch off your cell phone and ask your fellow colleagues and manager not to disturb you during the process unless it is an emergency.
Before you start walking through, sit in your office and mentally prepare your approach and the questions that you would like to ask.
When you are relaxed and ready, start working systematically through your inspection route – do not rush – take your time and do a quality inspection.
Write clearly on your form and give yourself memory joggers on the sheet to assist you later in recalling some of the facts.
Look at positive and negative factors.
Do not do fault-finding.
Remember: an inspection consist of documentation review, interviews and observation – make sure you have a balance in terms of these three information gathering techniques.
When you have completed your inspection, thank all the people that were involved.
Leave the area in a positive manner.
Go back to you office and finalize the content of the inspection report.
Report problem or high risk situations immediately to the respective supervisor or manager to prevent possible incidents.
Hand in your report to your next level of supervision.
Ensure that you form part of a committee who will sit on a regular basis to discuss these reports and make recommendations for continual improvement.
Give regular feedback to the employees on all issues (positive and negative).
Important tip: Your attitude and approach during the inspection will determine whether it will be a success or failure.
A typical approach towards interviewing an employee would be:
Good morning, my name is…
I am busy doing an inspection to assist the SHEQ management system with continual improvement opportunities.
You are a valuable part of this process and we would like to find out if we can make your job/task safer.
Do you mind if I ask you a few questions, please?
What are the hazards that you know of in your job?
Have you gone through induction training?
When was the last emergency evacuation drill performed?
Who is your management representative for SHEQ?
Has an incident occurred in your area over the past month?…etc…
I thank you for your honesty and for sharing this information with me.

If we want to be successful we must remember that: we must become the change we want to see – Mahatma Gandhi.
Contact Christel Fouche
Featured, Health & Safety, Uncategorized

Audit example with notes

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Monday, March 10, 2008

Effective QMS Auditing Master Class

Effective QMS Auditing Master Class aims to equip delegates with quality auditing skills and strategies to implement QMS to business sustainability.

Our international trainer, Aidan Madden is the Managing Director and Principal Consultant of He has 19 years of experience working in regulated pharmaceutical industries and has delivered training workshops to 29 companies and 918 delegates since setting up FivePharma. Some of his clients include Abbott Pharmaceuticals, Bayer, Pfizer, B Braun, Cardinal Health, Haupt Pharm, Tyco Healthcare, Schering Plough,

Dr. K. Sadasivan Pillai, the Associate Director of Quality Assurance for Orchid Research Laboratories Ltd will be presenting a case study on the 'AuditPpreparation" Process in Orchid research laboratories.

You and your organization will gain crucial insights into:

· Planning, conducting and reporting Internal Audits

· Planning an audit programme and contributing to audit external clients

· Applying risk analysis to assessing audit findings

· Summarising the key requirements of FDA CFR 211 and EU GMP requirements

· Interpreting requirements of QSR in the context of an audit

· Describing the role of quality audit in the maintenance and improvement of management systems

· Describing the roles and responsibilities of auditors and lead auditors

Planning and conducting an audit in accordance with ISO 19011 and demonstrating ability to plan and prepare effectively
Analysing and interpreting information in order to determine conformance with requirements, effectiveness, and areas for improvement
Reporting the audit, including writing valid, factual and value-adding audit reports

*A 30-minute examination will be conducted at the end of the training. Participants who successfully passes the examination will receive an official Certificate of Accomplishment from FivePharma and Certificates of Attendance form FivePharma and marcus evans.*

For the registration form, please use the following link:

If the link is inaccessible, please reply my mail, and I will reply as soon as possible.

To register, simply fill out the registration form with credit card details, attention it to Karyn Nair and fax it to +603 2723 6622.

Take advantage of the 10% Premier Plus discount and register 3 or more delegates.

Best Regards,

Karyn Nair
Marketing Executive

marcus evans

Telephone : +(603) 2723 6611

Fax : +(603) 2723 6622

Email :