Assessment Report - Puskesmas Alas - 7122011-Edit

Report
Ref:
2011/50635/OA1
Audit Report
For
UPT PUSKESMAS KECAMATAN ALAS
Date(s):
Standard(s)
audited:
December 8-9, 2011

ISO 9001:2008
Registrar of Standards (Holdings) Ltd, Incorporating: United Registrar of Systems Ltd, Registrar of Standards Ltd Global Registrars Inc. ROS
2010
AR2V1
Report
Ref:
2011/50635/OA1
Audit Report Content

Number of
Pages
Code
1
Cover Sheet
Audit Report Content Includes disclaimers
Audit Administration
Audit Objective, Executive and Findings Summaries
Audit Team Summary
Audit Findings Comments
Audit Findings Concerns
Audit Recommendation and Conclusion
Clauses of the standard(s) audited this visit
10
Next audit plan
11
Appendix 1 Corrective Action Plan Templates
Total Pages
18
Disclaimers and Notes
This report remains confidential between the client and the ROS group of companies (ROS, URS, GRI) and as such, should not be circulated to other
parties without the express permission, in writing, of both parties; with the exception of the ROS Group of Companies Regulators.
The contents of this report have been made by the impartial auditor(s) and are based on random samples selected during the audit Process.
As such, the report does not infer that the comments and/or concerns contained within this report are exhaustive in nature.
It will be assumed that the client fully accepts the findings within this report, unless notification, in writing, is made by the client to their local
office within 5 working days of the last day of this audit.
Contractual/Regulations/Liability - The client is reminded that this audit activity has been performed in connection with the quotation/contract and the
client should be aware of the scheme regulations and liability clauses which can be found on the ROS Group commercial websites (www.rosgroup.com , www.urscertification.com www.globalregistrars.com)
Whilst it is the ROS Groups policy to offer competitive fees, clients that cancel pre-arranged visits without at least 5 working days written notice,
may be charged for such a cancellation. Please refer to the Scheme Regulations that are stated on our websites, under
Regulations/Complaints/Appeals.
CODE M = mandatory report content, R = Required Content when Concerns or Comments are recorded. O = Optional report content.
Management System Requirement (MSR) is defined as a part of a clause of the standard. A total breakdown of a requirement (MSR) is a situation
where there is no evidence of implementation or, based on a reasonable audited sample size, implementation is not effective. A breakdown of a
requirement is a situation where the samples audited show some implementation but does not constitute a total breakdown.
Management System Clause (MSC) is defined as a collection of related requirements. A breakdown of a clause (MSC) is a situation where there
may not be a total breakdown of a requirement but a breakdown of more than one of the related requirements within that clause, whether the
breakdown of those requirements occur in a single department/process or more than one department/process, where that requirement is
implemented.
Note that the auditor has endeavoured to take a reasonable sample size based on the volume of the process output to test the effective
implementation of a clause or requirement. Reasonable sample size is subjective the client may request that the auditor expands the sample size
in order to confirm that the sample does not constitute a total breakdown.
2010
AR2V1
Report Ref:
2011/50635/OA1
Audit Administration
Client management
contact:
Mrs. Hj. Dr. Nieta Ariyani
Lead Auditor:
Hadi Nugroho
Audit days
2.0
Auditor:
Auditor:
Auditor:
Specialist:
NA
Translator:
NA
Other:
NA
Total audit days

2.0
Certification Scope
Management of Society Health Services Center

Temporary sites audited this visit (e.g.
construction)
Permanent sites audited this visit

Jl. Pahlawan no. 45 Alas 84353 Kabupaten
Sumbawa NTB, Indonesia
Notification of changes or other requests by the audit team or client
NIL
2010
AR2V1
Report Ref:
2011/50635/OA1
Audit Objectives
This audit was conducted to confirm that the clients Management System meets internal, customer and
regulatory requirements to fulfill the Goal of the standard that has been audited (e.g. ISO14001 the
Goal is the reduction or elimination of pollution, ISO/TS16949 the Goal is the reduction of variation and
waste in the supply chain, OHSAS18001 the Goal is the elimination or reduction of risks to
personnel or other interested parties).

The Executive Overall Summary (Part A) provides a synopsis as to the effectiveness of the clients
QMS. The Process Summary (Part B), provides a synopsis of the effectiveness of the individual
processes of the clients QMS. The Findings Summary (Part C) provides an indication of the total
Comments and Concerns recorded during this audit.
Executive Overall Summary (Part A)

Enhancement/Improvin
g
Satisfactory
Unsatisfactory/Degrading
Overall Commitment to the System
Effectiveness of System Controls
Overall effectiveness of processes

Effectiveness of Close-out to Issues, e.g.
Audits, Internally Raised Issues, Customer
audits
Customer Complaints Control
Setting of Targets & Objectives

Effectiveness of Achieving
Targets/Objectives/Improvements
Overall Compliance to the
Standard(s)/Scheme(s)
If the Audit Team confirms that the corrective actions taken to address any previous concerns raised are
Unsatisfactory then a Concern must be raised.
Effectiveness of close-out of the
Corrective Actions regarding the
Concerns raised from previous audits
by ROS, URS, GRI
2010
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Process Summary (Part B)

Enhancement/Improvin
g
Process Name
Satisfactory/Effective
Unsatisfactory/Degrading
Not Effective
Management
Representative (doc control,
internal audit, management
review,
customer
survey,
Resources
Management
(competence of personnel &
training, maintenance of
infrastructure procurement,
logistic)
Locket (registration, storage
of medical record)
Polyclinic (physicians, dental,
KIA-KB, MTBS (immunization) ,
etc)
Inpatient & Emergency
Response (ambulance,
emergency unit)
Supporting (pharmacy,
laboratory include calibration)
UKM (environmental health,
Nutrition, TBC, etc)
Findings Summary (Part C)

Total Comments
Number of Findings
Total Concerns
Total OFI/PNC
Total D (Minor NCs)
Total NC (Major NCs)
13
Enhancement/Improving means that there is evidence of improved process performance or improvements arising
from corrective actions.
Satisfactory means that there is evidence that requirements are being met but improvements have not yet been
realized due to recent implementation of systems. Or requirements are being met but no improvement plans have been
identified/implemented. This report may contain some comments: Opportunities for Improvements (OFI) or Potential NonCompliances (PNC).
Unsatisfactory/Degrading means that there is evidence of a decrease in process performance since the last audit. Or
corrective action has not been effective. Or requirements and/or client protocols have not been followed and/or
implemented fully. This report may contain some Discrepancies (Minor NCs) or Non-compliances (Major NCs).
2010
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Report
Ref:
2011/50635/OA1
Audit Team Summary

The operations of a Management System largely comply with ISO 9001:2008 requirements except
the Discrepancy (D) raised.
The PNCs and OFIs have been raised in this audit for the organization to continually improve the
established system. (see. Page Audit In addition to audit findings noted), there were also good
sample of quality practices such as: Top Management and all staffs shown high level of commitment
towards improvements ideas, good response in customer complaint performed.
UPT PUSKESMAS KECAMATAN ALAS will be recommended for awarding of ISO 9001:2008
certification after closure discrepancy.
2010
AR2V1
Report
Ref:
2011/50635/OA1
Audit Comments
Definitions of Comments
Describe Comment(s) below
A situation where the

evidence presented
indicates a
requirement has been
effectively
implemented but
based on auditor
experience and
knowledge, additional
effectiveness or
robustness may be
possible with a
modified approach
OFI
Due to the short

period
of
implementation of a
new
or
changed
process, or the audit
sample
taken,
the
effectiveness of the
system element could
not yet be determined
PNC
1. Quality objective has been established, however some quality

objective should refer to output of process and strategic plan
from Top management (5.4.1)
2. Seen business Process graph in the quality manual, however
some ISO 9001 : 2008 has not been determined in the
Business Process (4.1)
3. Seen list of external documents and internal
documents, however some of government regulation
has not been putted in a list, such as UU No. 29/ 2004
(Medical), UU No. 36/2009 (Health Act), PERMENKES
269/2008 (medical record) and some documents has
not been registered, such as medical record form, etc
(4.2.3)
4. Follow up action was conducted while audit findings occurs,
however root cause analysis has not been effectively
conducted as seen that follow up action only conducted for
correction action (8.5.2)
5. Follow up action was conducted for customer perception
survey, however monitoring of follow up should be improved
by providing due date and PIC (8.5.2)
6. Seen procedure for laboratory test, however standard of
sample stabilization and reading of laboratory results has not
been determined (7.5.1)
7. Calibration of measurement tools was scheduled, however
some tools, such as micropipette, test tube, etc, have not
been scheduled (7.6)
8. Seen some medical record in the inpatient unit, however the
medical record did not have record number (4.2.4)
9. At medical record storage, medical record was registered,
however medical record for patient kalsum has not been
found during audit (7.5.5)
10. At in patient, patient was registered, however patient identity
has not been attached on bed (patient Haeriah) (7.5.4)
11. Provision of medicine in pharmacies was conducted, however
ensuring homogeneity has not been established for
concoction of drugs (7.5.2)
12. Seen medicine stock monitoring at pharmacy, however stock
updated has not been effectively conducted, i.e :
Trihexyphenydil (7.5.5)
13. Seen medicine consumption monitoring for TB suspect,
however some suspect has not been updated, i.e : Hayat and
Rahma (7.5.1)
2010
AR2V1
Report
Ref:
2011/50635/OA1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
A defined protocol does
not exist or omits a
requirement from the
standard, regulations or
scheme rules
One or more process(s)

observed has/have not
been defined in the
clients management
system
Defined or required
protocol has not been
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
ISO 9001 : 2008
Regulation
State
reference/clause from
standard/regulation
scheme/process
Reason
Protocol does not address one or more shall(s) of a

requirement
A protocol exists but only partly addresses a requirement
Scheme
NC
Major
or D
Minor
NC
Major
D Minor
The process is customer facing (the last process prior to

delivery of product or service) - verification of
acceptability to deliver product/service
Process
The process is not customer facing and occurs before the

last process which verifies the product/service prior to
delivery -verification of acceptability to deliver
product/service
Process
(One Concern per Page only)
Non-conforming product or service could be delivered to

the customer e.g.: the process is final inspection, and
there is no other process to capture the product/service
under consideration.
Non-conforming product or service has not been
delivered to the customer e.g.: the process is NOT final
inspection, there is another process to confirm the
product/service is suitable after this process that has
been the subject of the concern, records prove that no
non-conforming product/service has been delivered.
8.2.2
The defined protocol has failed to ensure that the process

is effective in achieving process objectives and as a
result, non-conforming product or service has been
delivered to the customer (or for TS16949, could be
delivered based on process capability studies): or, there
is a total breakdown of an MSR or a breakdown of an
MSC (see contents page)
is effective in achieving objectives/targets (e.g. ISO9001,
5.4.1) and no improvement action has been
implemented: or, there is a breakdown of a requirement
(see contents page)
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor
Describe below, the objective evidence for the omission/concern

highlighted above:
Inadequate evidence that internal audit was effectively conducted as seen that internal audit
only conducted for clause 4.2.3 and 4.2.4
2010
AR2V1
Report
Ref:
2011/50635/OA1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
scheme rules

been defined in the
clients management
system
Defined or required
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
ISO 9001 : 2008
Regulation
State
standard/regulation
scheme/process
Reason

requirement
Scheme
NC
Major
or D
Minor
NC
Major
D Minor

Process

product/service
Process

5.4.1

(see contents page)
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor

highlighted above:
Quality objective was not effectively monitored as seen that monitoring of quality objective
was not conducted at all area
2010
AR2V1
Report
Ref:
2011/50635/OA1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
scheme rules

been defined in the
clients management
system
Defined or required
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
ISO 9001 : 2008
Regulation
State
standard/regulation
scheme/process
NC
Major

requirement
D Minor

Process

product/service
Process
NC
Major
or D
Minor
Reason

Scheme

7.5.1

(see contents page)
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor

highlighted above:
It was found that some medical action was not effectively conducted as seen for :
1. KIA-PONED : Medicine therapies was only recorded in the registration book and dose of
medicine was not determined
2. In Patient : Monitoring of medicine consumption was not effectively conducted for patient
An. Raju (Paracetamol, 3-4/12/11) and doctor instruction was not determined for patient
Ny. Haeriah (medicine : Ambroxol and Antasida)
3. Dental clinic : inadequate evidence that subjective symptoms, objective physical findings
(Internal Oral and External oral observation) and other condition were conducted for
patient Kartana and Maskendi
2010
AR2V1
Report
Ref:
2011/50635/OA1
Standard/Schem
e:
Definitions of
concerns
Mark as
relevant
Standard
scheme rules

been defined in the
clients management
system
Defined or required
followed
Defined or required
protocol has been
followed but is not
effective
Concern No:
ISO 9001 : 2008
Regulation
State
standard/regulation
scheme/process
Reason

requirement
Scheme
NC
Major
or D
Minor
NC
Major
D Minor

Process

product/service
Process

7.5.1

(see contents page)
Protocol
NC
Major
D Minor
NC
Major
D Minor
NC
Major
D Minor

highlighted above:
Inadequate evidence that Triage procedure was effectively conducted in the emergency unit
as seen that triage record was not provided
2010
AR2V1
Report Ref:
2011/50635/OA1
Audit Recommendation and Conclusion

A copy of this page must be used for each standard/scheme that has been audited during this visit.
Applicable Standard
ISO 9001:2008
Current Activity
Indicate current audit activity
On-Site
Audit
Surveillanc
e
ReCert.
Special
Client Required Action
Consider the Comments Raised

For the Next Activity
Required
records to
be sent to
local office
within 20 of
days as
indicated
below
Send in a Corrective Action Plan for

the Discrepancy Point(s) Raised
Send in a Corrective Action Plan plus
Evidence for the Discrepancy
Point(s) Raised
Send in a Corrective Action Plan plus
Evidence for the Non-compliance
Point(s) Raised
Audit Conclusion
Certification is Recommended
proceed to issue Certificate(s)
Continued Certification and/or ReCertification is Recommended
Certification is Recommended
subject to any actions stated above
being satisfactorily addressed
proceed to issue certificate(s)
Suspension of Certification
Recommended
Continued Certification and/or ReCertification is Recommended

subject to any actions stated above
being satisfactorily addressed
Withdrawal of Certification
Recommended
A successful Special Visit is required prior to Certification proceeding or continuation of

Certification
Client acceptance of the recommendations and conclusion
Client representative name:
Client representative sign:
Mrs. Dr. Nieta Ariyani
2010
AR2V1
Report Ref:
2011/50635/OA1
Clauses of the Standard(s) audited this visit
ISO10002
4.8
4.9
4.2
4.3
4.4
4.5
4.6
4.7
5.3.
3
5.3.
4
5.3.
5
6.2
6.3
6.4
7.1
7.8
7.9
8.1
8.2
8.3
8.4
8.5
4.1
4.2
7.1
7.2
4.10
5.1
5.2
5.3.
1
5.3.
2
7.2
7.3
7.4
7.5
7.6
7.7
8.6.
1
8.6.
2
8.6.
3
8.7
ISO9001 (Inc. TS16949, AS9100, ISO13485, PAS43)

5.1
5.2
5.3
5.4
5.5
5.6
6.1
6.2
6.3
7.3
7.4
7.5
4.1
4.2
5.1
5.2
5.3
5.4
5.5
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.6
8.1
8.2
8.3
ISO22000
5.6
5.7
7.9
7.10
8.4
6.4
8.5
5.8
6.1
6.2
6.3
6.4
8.1
8.2
8.3
8.4
8.5
3.1
3.2
3.3.
1
3.3.
2
BS EN 16001
3.3.
3.4.
3.4.
3
1
2
3.4.
3
3.4.
4
3.4.5
3.4.6
3.5.
1
3.5.
2
3.5.
3
3.5.
4
3.6.
2
3.6.
3
Annex 1
3.1
3.2
3.3
4.1
4.2
4.3
6.3
6.4
6.5
6.6
7.1
7.2
4.1
4.2
4.3.1
4.3.
2
4.4.5
4.4.6
4.4.7
4.5.
1
4.1
4.2
4.3.
1
4.4.
5
4.4.
6
4.4.
7
4.
1
4.
2
4.
3
3.5.
5
3.6.
1
ISO20000
4.4
4.4.
1
7.3
8.1
ISO 14001
4.3.
4.4.
3
1
4.5.
2
4.5.
3
OHSAS 18001
4.3.2
4.3.
4.4.
3
1
4.5.1
5.
1
5.
2
4.5.
2
4.5.
3
ISO27001
6.
7.
8.
0
0
1
4.4.
2
4.4.
3
6.1
6.2
8.2
8.3
9.1
9.2
10.
1
4.4.
2
4.4.
3
4.4.4
4.5.
4
4.5.
5
4.6
4.4.
2
4.4.
3
4.4.4
4.5.
4
4.5.
5
4.6
8.
2
8.
3
7.1
Annex
A
Other standard - (auditor to complete matrix)
Mandatory processes to audit each visit

Internal
Audits
Policy
Document &
Data Control
Reviews
Corrective
Actions
Complaints
Use of Logos
(After Stage
2)
2010
AR2V1
Confirm that the Client Management Contact has been made aware that PNCs raised during
this activity could result in concerns (Ds or NCs) being raised at the next visit.
Confirmed
2010
AR2V1
Audit Plan for Next Visit

Standard(s) / Scheme(s) to be audited next
activity
ISO 9001:2008
Month/year for next activity
November 2012
On-site
audit
The Plan below relates to the next Audit

Activity
DAY
1
Process
Surveillanc
e
DAY
Start
Time
Auditor
Re-cert
Special
2
Process
Start
Time
Auditor
To be
TBA
Advise
d
Report preparation
16.0
0
Closing (wash-up/final)
meeting
16.3
0
Notes and disclaimer:
The plan MUST reflect the client's processes, planning by clause of a standard is NOT acceptable If the
audit duration exceeds 2 audit days use more sheets.
The exact date of the next activity will be notified to the client by letter, e-mail or telephone and shall
be agreed mutually between both parties.
2010
AR2V1
Report Ref:
2011/50635/OA1
Appendix 1
Corrective Action Plan (CAP) Template - (Client copy one CAP for each concern)
This format is optional but has been created to assist the client in addressing the Concerns raised,
however, if the client chooses to use their own format, the headings below should be used.
Report Ref:
2011/50635/OA1
CAP for Concern No:
Enter below, the EXACT details of the objective evidence for the omission/concern in the related concern report - :
Inadequate evidence that internal audit was effectively conducted as seen that internal audit
only conducted for clause 4.2.3 and 4.2.4
Who will be responsible for managing the corrective and preventive actions (if necessary establish a team of
people with product/service/process knowledge)?
Yang bertanggung jawab atas tindakan korektif diatas adalah dr. Nieta Ariyani (coordinator Audit Internal)
What immediate actions are to be taken to contain the problem and protect your company and your
customers?
dilakukan audit internal ulang untuk memastikan bahwa audit internal meliputi semua klausul dalam ISO
9001 : 2008 dan dilaksanakan pada tanggal 12 dan 13 desember 2011
Identify all potential causes that could explain why the problem occurred. Ask what in our processes failed or
was missing, to make this problem occur? (a useful method to identify root cause is 5Y)
Manusia : kurang memahami penerapan klausul karena masih baru pembelajaran
Metode : sudah ada metode Audit yang dijelaskan dalam prosedur Audit Internal
Bahan/Peralatan : sudah terdapat media untuk melakukan Audit Internal yaitu checklist Audit
Choose and state Permanent Corrective Actions (and consider the impact the actions may have on other
processes, documentation, personnel awareness etc.)
masalah terjadi karena sumberdaya manusia yang kurang kompeten sehingga akan dilakukan pelatihan
atau diskusi untuk meningkatkan kompetensi dan membuat checklist audit dengan lebih baik yang mengacu
pada semua klausul
Planned date of
implementation of
Auditor Name:
10-12-2011
Organizations
Representative Signature:
Nurhayati
Auditor Sign:
2010
AR2V1
Report Ref:
2011/50635/OA1
Appendix 1
Report Ref:
2011/50635/OA1
CAP for Concern No:
Quality objective was not effectively monitored as seen that monitoring of quality objective was
not conducted at all area
Masing-masing kepala unit dan mr
customers?
monitoring pencapaian sasaran mutu untuk bulan November 2011 dibuat dengan lengkap
Manusia : belum sempat membuat karena kesibukan kerja
Metode : sudah dibuat penetapan sasaran mutu masing-masing unit
Bahan/data : sudah tersedia data untuk melakukan monitoring pencapaian sasaran mutu untuk bulan
November
masalah terjadi karena SDM yang kurang disiplin dan ditetapkan bahwa penyampaian laporan
pencapaiaan sasaran mutu dilakukan maksimal tanggal 2 bulan berikutnya
Planned date of
implementation of
Auditor Name:
10-12-2011
Organizations
Auditor Sign:
2010
AR2V1
Report Ref:
2011/50635/OA1
Appendix 1
Report Ref:
2011/50635/OA1
CAP for Concern No:
It was found that some medical action was not effectively conducted as seen for :
1. KIA-PONED : Medicine therapies was only recorded in the registration book and dose of
medicine was not determined
2. In Patient : Monitoring of medicine consumption was not effectively conducted for patient An.
Raju (Paracetamol, 3-4/12/11) and doctor instruction was not determined for patient Ny.
Haeriah (medicine : Ambroxol and Antasida)
3. Dental clinic : inadequate evidence that subjective symptoms, objective physical findings
(Internal Oral and External oral observation) and other condition were conducted for patient
Kartana and Maskendi
customers?
Planned date of
implementation of
Auditor Name:
10-12-2011
Organizations
Auditor Sign:
2010
AR2V1
Report Ref:
2011/50635/OA1
Appendix 1
Report Ref:
2011/50635/OA1
CAP for Concern No:
Inadequate evidence that Triage procedure was effectively conducted in the emergency unit
as seen that triage record was not provided
customers?
Planned date of
implementation of
Auditor Name:
Organizations
Auditor Sign:
2010
AR2V1

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Report

December 8-9, 2011

Audit Report Content

Audit Report Content Includes disclaimers

Audit Objective, Executive and Findings Summaries

Audit Team Summary

Audit Findings Comments

Audit Findings Concerns

Audit Recommendation and Conclusion

Clauses of the standard(s) audited this visit

Next audit plan

Appendix 1 Corrective Action Plan Templates

Disclaimers and Notes

Mrs. Hj. Dr. Nieta Ariyani

Total audit days

Management of Society Health Services Center

Permanent sites audited this visit

Notification of changes or other requests by the audit team or client

personnel or other interested parties).

Executive Overall Summary (Part A)

Overall Commitment to the System

Effectiveness of System Controls

Overall effectiveness of processes

Setting of Targets & Objectives

Process Summary (Part B)

Findings Summary (Part C)

Total D (Minor NCs)

Total NC (Major NCs)

Audit Team Summary

Describe Comment(s) below

A situation where the

Due to the short

1. Quality objective has been established, however some quality

One or more process(s)

ISO 9001 : 2008

Protocol does not address one or more shall(s) of a

A protocol exists but only partly addresses a requirement

The process is customer facing (the last process prior to

The process is not customer facing and occurs before the

(One Concern per Page only)

Non-conforming product or service could be delivered to

The defined protocol has failed to ensure that the process

Describe below, the objective evidence for the omission/concern

One or more process(s)

ISO 9001 : 2008

Protocol does not address one or more shall(s) of a

A protocol exists but only partly addresses a requirement

The process is customer facing (the last process prior to

The process is not customer facing and occurs before the

(One Concern per Page only)

Non-conforming product or service could be delivered to

The defined protocol has failed to ensure that the process

Describe below, the objective evidence for the omission/concern

One or more process(s)

ISO 9001 : 2008

Protocol does not address one or more shall(s) of a

The process is customer facing (the last process prior to

The process is not customer facing and occurs before the

A protocol exists but only partly addresses a requirement

(One Concern per Page only)

Non-conforming product or service could be delivered to

The defined protocol has failed to ensure that the process

Describe below, the objective evidence for the omission/concern