company confidential 1 9104/1 status mike roberts 14 sept. 2010

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Company Confidential 9104/1 Tentative Schedule (Part 1)

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Page 1: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential 1

9104/1 Status

Mike Roberts14 Sept. 2010

Page 2: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

Status: 9/14/2010

Sect

ion

Title

Boo

k Bos

s

Stat

us

12 OASIS Hans L ok13 Req. OPMT Rick D ok14 OASIS Feedback Hans L ok15 SMS Tim L ok16 Cross Frontier Ian F ok17 Records Tim L ok18 Req. Certified Orgs Mike R ok19 Confidentiality and Confl. of Int. Jean-Louis / Susie ?20 Fees and Financials Mike R ok21 Notes Jeff W ok

App A Acronyms Mike R okApp B Required Data in OASIS Hans L okApp C Site Concept Diagrams Tim L in reviewApp C Site Org. Req'mts Matrix Tim L in review

Sect

ion

Title

Book

Bos

s

Stat

us

G (General Comment) Mike R okR Rationale Mike R okF Forward Mike R ok

ToC Table of Contents Jeff W last1 Scope Rick / Mike R ok2 References Tim L ok3 Definitions Lori S-G ok4 Req. SMS Tim L ok5 Req. ABs Ian F ok6 Req. CBs Tim L ok7 Req. Auditors Jean-Louis / Will ?8 Req. Audits & Reporting Rick D in review9 Req. Oversight Tamaki N ok10 Req. AABs Mike G / Tim L ?11 Req. TPABs Mike G / Tim L ?

Page 3: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

9104/1 Tentative Schedule (Part 1)

10-Sep-10 Team Lead Completes Draft Incorporating All Comment Submissions

13-Sep-10 Chapter 8 Book Boss & OPMT Chair Review of Draft

16-Sep-10 AAQG / AAQSC / RMC Meetings in Salt Lake City

24-Sep-10 Complete Draft Revision

4-Oct-10 Complete IAQG Editor Review (10 Days)

6-Oct-10 Team Lead Emails Draft to All Book Bosses, OPMT Members, SMS Focals

19-Oct-10 OPMT / IAQG 9104-1 Review (York England)

1-Nov-10 Final Comments and Go-Forward Approvals Due to 9104-1 Team Lead

5-Nov-10 Begin Ballot

Page 4: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

9104/1 Tentative Schedule (Part 2)

5-Nov-10 Begin Ballot

3-Dec-10 Ballot Complete in Americas (1 month)

3-Jan-11 Ballot Complete in Asia-Pacific (2 months)

3-Feb-11 Ballot Complete in Europe (assuming short 3 month ballot)

7-Feb-11 Receive comments from IAQG/EAQG Document Focal

21-Feb-11 Complete Review of Comments (2 weeks)

21-Mar-11 Complete Review by Sector Standards Councils (30 days)

4-Apr-11 Publish (English Version) (2 weeks)

Page 5: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

Executive Decisions• IAQG LT / SWG Sanctioned ‘Special Team’ To

Define “Sites” and Auditor Day Requirements– Five Categories of Site ‘Certification Structures’

» Single Site» Multiple Site» Campus» Several Site» Complex

– Table 2 from Previous Ballot Remains the Same– Table 6 from Previous Ballot Remains the Same

Page 6: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

Executive Decisions (Continued)

•9104/1 Book Bosses Sent to the 9104/1 TL, the Reviewed Comments for All 29 Sections and Chapters of the Standard.– Many comments implemented– Several comments rejected

» Example: Did not change 8 hour Audit Day

•Still Working to Integrate the 18 Page Document Incorporating the New Requirements from the ‘Special Team’.– Causing some document structure changes

» Table 2 becomes Table 3

Page 7: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

Executive Decisions (Continued)

•9104/1 TL, OPMT Chair, and Sect. 8 Book Boss decided to simplify Section 8.2.2.h (multiple certifications, additional certifications)– Removed confusion in calculating audit days.– Removed examples / tables that raised questions– Added simplified audit day calculation

» Table[Total # employees] + 20%– May add examples

Page 8: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

Executive Decisions (Continued)

•Time for filling out forms is not included in Audit Day Table (8.2.2.c), but we added:– “Note: The entry of data on the 9101 Obective

Evidence Record (OER) during on site audit time is acceptable.”

•“Audit calculations shall round up to the nearest ½ day.”

•“Audit activity shall never be less than 1 audit day per site.”

Page 9: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

Issues and Comments• We have reduced auditor days for organizations with

“no design”. But we also have a number of organizations with “no manufacturing”. Should we consider “no manufacturing” be an “or” criteria for the “no design” reduced audit day table column?

• There is nothing in the requirements that an AEA must close out a corrective action / finding. Should this be added to the upcoming 9104/1 draft?

• Notified that there may be some conflict between what 9101D and draft 9104/1 says about the certificate transfer process. (Comment referenced 4.3.6 and Special Audit Transfer / Pre-transfer review.

Page 10: Company Confidential 1 9104/1 Status Mike Roberts 14 Sept. 2010

Company Confidential

That’s All, Folks