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Can ISO inspector request specific mixing times in Cosmetic Production?
Hello,I will appreciate any advice with my difficult question. Our ISO (22716) certification inspector said “you shall have specific mixing times in your batch record”. Anybody can help me with that requirement? I understand we need clear and measurable requirements but it would be somewhat challenging to meet that requirement in production, speaking operational way. Operators are not robots. I was thinking to replace let say mix for 1:45 minutes by NLT 1:45 and NMT 2:00 hours. I honestly can’t find where the requirement says that you cannot have a tolerance. Any advice will be highly appreciated.Thank you!!! -
3 Replies
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@Landmark
I believe what inspector might be saying is you need to time for each step on production batch sheets. For example; lets says you are making a batch of shampoo:
Step 1: add 1500kg of water
For this step, you need to have start time and end time. Start time: 9:00AM, when you started pumping water, lets say End Time:10:30 AM Once you are done pumping water
Step 2: Add 100kg of Sodium Lauryl Sulfate Start Time: 10:40AM End Time: 11:00AM
Basically you need to have duration of each step mentioned in your batching record, there is no limit how long you want to mix it -
Yes, we always listed the time of day each ingredient is added to a production batch.
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I’ll add to always use the 24-hour clock (international standard), especially where ISO auditors are involved. I went out and bought large digital 24:00 clocks for the Compounding Departments where I worked to keep the guys in the habit. Didn’t take long for them to report 3:45PM as 15:45.
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