ISO 17025 Pre Bid Conference - Q A.pdf

Pre Bid Conference, ISO 17025

Q & A

1. Should a formal Gap Analysis be included in the bid proposal? Yes

2. How many methods does the laboratory intend to include in their ISO 17025:2005 accreditation for the analysis of pathogens? One (Salmonella) for the first audit with the other pathogens to follow in the contract cycle.

3. How many sites are involved in this action? Where are they located?

One site, the Bureau of Food Safety & Laboratory Services is 2301 North Cameron Street, Harrisburg PA.

4. Does the lab or any part of it have experience with ISO 17025 requirements? None

5. Which sections of the lab are seeking accreditation? Just Microbiology, or will chemistry

(pesticides) be accredited also. Just Microbiology at the present time

6. If limited sections of the lab are seeking accreditation, will other parts seek accreditation later? It is possible in the future.

7. Will other programs such as Feed and Grain come under accreditation? Not at the present time.

8. Are any parts of the laboratory working as part of FERN (Food Emergency Response Network)?

Yes, Microbiology and Chemistry sections.

9. Are any parts of the laboratory providing/sharing data with USDA? Not at the present time

10. How many Laboratories will be used and where are they located?

One laboratory and the location is 2301 North Cameron Street, Harrisburg PA

11. What equipment is being used, organisms and labs? VIDAS 30 used for screening as per BAM and VITECK II for biochemical confirmation Is there a list of methods and analysis? Yes

12. Is this USDA or FDA associated? FDA associated

13. What is the timeline for accreditation? July 31, 2015

14. Do you have detail on the extent of documentation? Yes Is it in final form or still under review? Some are in final form, other are still under review

15. Is the lab AVLD? No

16. Does the contract include fees for accreditation? Yes, the accreditation fees are part of the contract. The only fee paid by PDA would be the cost to receive the accreditation certificate.

17. Do you want to know what the fees are in the proposal? Yes, we want an itemed listing of fees.

18. Do you expect the contractor to do the training? Yes, the contractor is responsible for all ISO related training.

19. Will there be an extra charge for training of laboratory staff and contract training? No

20. Will all Laboratory personnel be involved in the program? Just the Microbiology section

21. Will there be cross training? Yes, among the Micro staff.

22. How many people are in the area/laboratory? Four (4)

23. Are the executive positions in support of the proposal? Yes

24. Who are the quality managers? The Laboratory Chief and Bureau Director

25. What computer software does The Bureau of Food Safety & Lab, Laboratory division use?

USALIMS

26. Do you have a computer program to make the system paperless? Yes

27. What dedicated staff is planned for the program? Four (4) Microbiologist

28. Does the contractor qualify the dedicated staff? No

29. How will the payments be based? The payments will be made monthly based upon approval from the Bureau Director and Chief of Lab that the milestones were reached and performance is acceptable.

30. Will there be daily discussions with the Chief of Laboratory, if so how often and when will they start? Discussions will be at 9:00 am to 9:30 am. Will there be back-up for the Chief of

Laboratory? Yes, the Bureau Director

31. What are the Assays that are most important? Salmonella detection in food, milk and dairy products and animal feed.

32. What are the Laboratory work hours? 8:00 am to 4:00 pm, Monday - Friday

33. Will there be any field testing? No

34. Is the process of sample collection included in the scope? No

35. What is the Organizational structure? Please see the attached organizational chart.

36. Do you know the policy to start the program? (We are not sure what this question means?)

37. Will FDA be monitoring the process? Yes

38. How will the proposal be set forth? Bill can you answer this question?

39. Will a contractor be included in the discussions with FDA? Yes

40. Will the BFSLS extend the due date? The date for the contract submission has been extended. The contract extension depends on the grant funding.

41. How soon would you anticipate a contract? By approximately January 2, 2015

42. How do you define a company? The contract is with a State Department/Bureau

43. What is the designated category for the Bid? Bill can you answer this?

44. What is the grant cycle and has FDA set a date? 8/3/2014-7/31/2014

45. Do you have to pay for Accreditation costs, how often will you need one?

The Department will perform them according to the necessary time frames to be accredited.

See # 16.

46. When the auditor comes what is the procedure? The contractor and Chief of Lab will work with the Auditor.