QEF08EL Non Conformance Report

Jl. Tjilik Riwut Km 3,5 No. 13,

Balai Pengawas Obat dan Makanan Di Palangka
Organisation Name: Location: PALANGKARAYA, Kalimantan Tengah,
Raya
Indonesia
Dhidiek Agus
Date: 11/01/2018 Audit team leader: Activity/Report ID: WI-695987 License/Certificate No.: CEM21840
Mulyono

Organisation’s acknowledgement of receipt of NCR Employee Name: Mei Indarti, SF. Apt Date NCR Accepted: 11/01/2018
Section 1 Section 2 Section 3 Section 4

Details of non-conforming SAI Correction : Root Cause and Corrective SAI Global SAI Global Verification of Corrective
N situation and Objective Verification Action : Response Review: Action for Effectiveness:
(immediate fix)
C Evidence : (how and (action to prevent recurrence)
Standard(s)
R Classification when)
& clause(s)
Nr
.

1 14001:2015 Minor It was observed that policy Due Date: Correction: Root Cause: Response: Verification of Effectiveness:
5.2 statement was not include SELECT Akan dimasukkan Manajer puncak belum Acceptable
includes a commitment to the dalam kebijakan mengikuti understanding Name
protection of the SAI lingkungan ISO 14001:2015 28/02/2018
environment, and other Follow up Reviewer: Dhidiek Date:
specific commitment(s) Method: Agus Mulyono
SELECT SELECT
relevant to the context of the
Corrective Action:
organization.
Manajer puncak
dijadwalkan mengikuti
understanding ISO
14001:2015

2 14001:2015 Minor There was no evident that Due Date: Correction: Root Cause: Response: Verification of Effectiveness:
8.1 measurement for vehicle SELECT Akan dilakukan uji Belum dilakukan update Acceptable
emission has been done in emisi terhadap terhadap peraturan terkait Name
2017 and 2018. SAI kendaraan dinas 28/02/2018
Follow up Reviewer: Dhidiek Date:
Method: Agus Mulyono
SELECT Corrective Action: SELECT

Update peraturan terkait

pengelolaan lingkungan
dan dilakukan evaluasi

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 Section 1 Section 2 Section 3 Section 4

Details of non-conforming SAI Correction : Root Cause and Corrective SAI Global SAI Global Verification of Corrective
N situation and Objective Verification Action : Response Review: Action for Effectiveness:
(immediate fix)
C Evidence : (how and (action to prevent recurrence)
Standard(s)
R Classification when)
& clause(s)
Nr
.

3 14001:2015 Minor Internal issues has been Due Date: Correction: Root Cause: Response: Verification of Effectiveness:
4.1 identified, however it was not SELECT Akan dimasukkan Sistem IPAL belum Acceptable
included the potential of sebagai isu internal difungsikan dengan optimal Name
WWTP performance. In 2018 SAI 28/02/2018
there was a project to Follow up Reviewer: Dhidiek Date:
improve WWTP Method: Agus Mulyono SELECT
performance. SELECT Corrective Action:
Perbaikan sistem IPAL

4 14001:2015 Minor Several review was also Due Date: Correction: Root Cause: Response: Verification of Effectiveness:
6.1.2 mentioned during discussion SELECT Akan dimasukkan Belum dilakukan update Acceptable
regarding to the lifecycle dalam ASDAM ASDAM Name
perspective such as SAI 28/02/2018
implementing of 4R in the Follow up Reviewer: Dhidiek Date:
process as well as Method: Agus Mulyono SELECT
considering to energy SELECT Corrective Action:
saving, however it was not
Akan dilakukan update
mentioned in the
ASDAM
environmental aspect
identification.

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 SAI GLOBAL
REGISTRATION PROGRAM
INSTRUCTIONS FOR THE COMPLETION OF NON-CONFORMANCE REPORTS (NCR)

Failure to provide action plans as arranged with SAI Global and/or to implement correction and corrective action within the nominated time frames may lead to a recommendation that your certification be denied
or suspended. Certain sectors require both Major and Minor NCR’s to be cleared within a specified time. Refer to sector specific requirements for details.

Section 1

To be completed by the SAI Global Team Leader at the time of the audit. A copy of the NCR shall be left with the Client at the completion of the audit.

Organization Acknowledgement: Name of the organizations representative who was presented the non-conformance. Signature is not required.
SAI Global Verification Method Record if site visit is required or what information is to be provided to effect NCR closure.

Section 2 - Organization Response

Complete Section 2 as described below and return it to SAI Global. In lieu of completing SAI Global NCR form, the Client may submit an equivalent corrective action document.

Root Cause: Consider using appropriate root-cause analysis tools such as, 5 Why’s, FMEAs, Fault tree analysis and fish bone diagrams, etc., to
ensure identification of root cause.
Correction: Describe the action taken to correct the incident and contain the problem. Objective evidence in the form of revised procedures,
records, etc. shall be submitted unless otherwise identified by the Audit Team Leader
Corrective Action: Client shall describe the systemic (long term) corrective action(s) planned or taken to eliminate the root cause to prevent recurrence.
Objective evidence in the form of revised procedures, records, etc. shall be submitted unless otherwise identified by the Audit Team
Leader.

Section 3

The SAI Global Team Leader /Client/Project Manager will review the completed NCR or Client’s equivalent corrective action document for adequate root cause analysis, systemic corrective action taken on root
cause and objective evidence submitted. Upon completion of the review the SAI Global Team Leader will either accept the corrective action taken and clear the NCR or request that the Client provide an additional
or revised response or objective evidence in order to clear the NCR. Comments shall be added to the hardcopy of the NCR or electronically as appropriate to identify any request for additional information, including
the date for submittal.

Section 4 – Verification of Effectiveness and NCR Closure

Detail what evidence was sighted to verify the effectiveness of the clients correction and corrective action. Where appropriate,
Verification of Effectiveness records of the client’s method of verifying effectiveness can be utilized but must demonstrate the correction, root cause and
corrective action. Record in the results the actual method and documents reviewed to verify effectiveness.
NCR Closure Name and date of individual performing the verification and NCR closure.

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