Hello, everyone.
We had MDD audit this year and NB auditor said clearly "you must audit your foreign factory (making class II devices) at least ONCE A YEAR. NB must audit them according to ZLG3.9 B17 if you fail to show clear evidence of good controlling. "
My question is,
1. Is this true? If so, is there any document saying manufacture must audit critical suppliers once a year?
2. Is this just because NB is a German organization? How about other NB like SGS? I am told that other NBs never say such a thing.
3. How often should we conduct an audit for "critical supplier" It is not cheap to go there every once a year. One of critical suppliers is located abroad. How often do your company go and audit?
4. We don't have a staff member who speaks English and full of knowledge on regulations. How do you handle such situation in your company? One person never cover them all, two or three people must go visit suppliers. We can't afford that.
5. We will have an inspection from FDA soon. Are they going to say the same thing?
I appreciate for your help very much.
We had MDD audit this year and NB auditor said clearly "you must audit your foreign factory (making class II devices) at least ONCE A YEAR. NB must audit them according to ZLG3.9 B17 if you fail to show clear evidence of good controlling. "
My question is,
1. Is this true? If so, is there any document saying manufacture must audit critical suppliers once a year?
2. Is this just because NB is a German organization? How about other NB like SGS? I am told that other NBs never say such a thing.
3. How often should we conduct an audit for "critical supplier" It is not cheap to go there every once a year. One of critical suppliers is located abroad. How often do your company go and audit?
4. We don't have a staff member who speaks English and full of knowledge on regulations. How do you handle such situation in your company? One person never cover them all, two or three people must go visit suppliers. We can't afford that.
5. We will have an inspection from FDA soon. Are they going to say the same thing?
I appreciate for your help very much.