Professional Documents
Culture Documents
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: WC Heng / Vani ISO Clause: 4.1, 4.2
4.2
1. Who are the interested parties that are relevant to the QMS? There are a few external parties that are interested to company. These parties would
include major customer such as Knowles & Multitest, government agencies such as Conformance
JKKP, DOE and Health Ministry.
2. Who are the interested parties that are relevant to the QMS? Chemlite would fully fullfill all the necessary customer requirement. Conformance
Audit Date: 21/8/2017 Auditor: WC Heng / Vani ISO Clause: 4.3, 4.4
2. What are the requirement of ISO9001:2015 applicable within the All included except design of products whereby Chemlite does not require any design
Conformance
determined scope of the QMS? as the company received the part which are completed designed.
3. Evidence of the scope of the QMS available. Yes, refer to Quality Manual. There are existence of standard operational procedure
Conformance
(SOP), process control plan (PCP) and work instruction (WI).
4.4
1. Has the organization established, implemented, maintained and Yes, there are work instruction for various processes within the organization such
continually improved its QMS, including processes needed and their as training process, purchasing process, production control process and etc. Two
interactions? observation was issued.
Observation
First observation, WI-106 does not updated to current company situation whereby
there was AM (Assistant Manager) to approve P/O.
Second Observation. The business flow in quality manual not correct. For example:
the flow linkage between Quality Assurance & supplier was wrong.
Audit Date: 21/8/2017 Auditor: WC Heng / Vani ISO Clause: 4.4, 5.1
3. Is documented information to support the operation of its processes Yes. Evidence was found in Quality Manual. Conformance
maintained ?
4. Documented information to have confidence the processes are beingAuditee show high level of confidence while answering the question. Conformance
carried out are retained ?
5.1
1. How does top management show their leadership and commitment Top management show their leadership by employing consultant regarding QMS.
with respect to the QMS? Top management also employ specific personnel to ensure the smooth flow of QMS.
Conformance
Top management also setup company's quality policy and quality objective to show
commitment towards QMS.
2. How does top management demonstrate leadership and commitmentTop management will always fullfill all the necessary customer requirement in short
Conformance
with respect to customer focus. time manner.
Audit Date: 21/8/2017 Auditor: WC Heng / Vani ISO Clause: 5.2, 5.3
2. Is quality policy communicated, understood and implemented? There were no training record for updated quality policy. A NCR was issued. Non Conformance
Available to relevant interested parties?
5.3
1. Are responsibilities and authorities for relevant roles assigned, Yes, management team lead by manager JK Ong would hold the responsibilites to Conformance
communicated and understood? ensure the well flow of ISO 9001.
2. Who is responsible for ensuring the QMS conforms to the Manager, JK Ong. Conformance
requirements of ISO9001?
3. Who ensures that the processes are delivering their intended outputs Document Controller, Vincent Lau. Conformance
4. Who reports to top management on the performance of the QMS Manager, JK Ong. Conformance
and on opportunities for improvement? Is the integrity of the QMS Yes, company currently on track to update ISO9001:2008 to ISO9001:2015.
maintained when change to the QMS are planned and implemented?
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: WC Heng / Vani ISO Clause: 6.1, 6.2
2. Are actions planned to address theses risks and opportunities? Always depends on customer. Action will be taken once company receive any
Conformance
request from customer.
3. Are actions integrated and implemented into the QMS processes Yes, each action will be evaluated together with respective customer when
Conformance
and their effectiveness evaluated? implemented.
6.2
1. Are quality objectives established at relevant functions, levels and Yes, quality objectives do established in each department. However, all the quality
processes? objective does not approve by manager. One NCR was issued. (Will be evaluated Non Conformance
again once we the NCR was answered)
Audit Date: 21/8/2017 Auditor: WC Heng / Vani ISO Clause: 6.3, 7.1
2. Purpose, potential consequences, integrity of QMS, availability of Yes, management team shows all the criteria. Conformance
resources and allocation of responsibilities and authorities considered.
7.1
1. Organization determines and provides the resources needed for Yes, the necessary equipment and manpower. Conformance
operating the QMS?
2. Capabilities and constraints of internal resources? External providersAll the internal resources are in place. Conformance
required?
3. People necessary for the effective implementation of QMS provided Yes, the necessary manpower are in place. Document Controller, Vincent Lau. Conformance
4. Knowledge necessary for the operation of processes and to achieve Yes. As shown in the internal training record. Conformance
conformity of products determined and maintained ?
CHEMLITE
AUDIT CHECKLIST
6. Enviroment necessary for the operation of proceeses provided and Yes. Conformane
maintained.
7. Monitoring and measuring resources needed to ensure valid and Yes. Conformance
reliable results provided? Suitable? Maintained? Check for evidence.
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: WC Heng / Vani ISO Clause: 9.1, 9.2
2. How do you obtain informations relating to customer opinions on The informations are available by customer surveys, emails and complaints. All the
Conformance
your products and services? feedbacks and complaints will be compiled in a logbook for reviews.
3. Does the organization consider the customer opinions and feedbacksYes. Emails that received from the customers on complains and feedbacks will be
in order to improve the quality of products and services? forwarded to all the middle management. Even if the complaint is conveyed in verbal
Conformance
JK Ong (Manager) will make sure the message is transferred to all the middle
management.
4. Are the internal audits being conducted at planned intervals? Yes. Conformance
5. Are the internal auditors trained? Yes. They are trained by the ISO consultant. The auditors are not allowed to audit Conformance
their own area.
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: WC Heng / Vani ISO Clause: 9.3, 10.1, 10.2, 10.3
2. What kinds of information are reviewed in management review? 1.Quality policy and objectives
2.Results of audit
3.Customer feedback
4.Process performance and product conformance
Conformance
5.Status of preventive and corrective actions
6.Follow-up actions from earlier management review
7.Changes that could affect the quality management system
8.Recommendations for improvement
2. Does the organization continually improve the suitablity, adequacy Yes. It will be discussed in management meeting. Conformance
and effectiveness of QMS?
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
2. Check for the situation where the people may find the Did not found the difficulties place. Conformance
difficulties to work in the work place.
3. Is organisation provide any safety precaution is carried during Chemlite have provide the satety precaution in work place.
operation time? Check for PPE, eye and body wash station and PPE are wear by the operator. Total of 6 body wash station, eyewash bottle and
so on. 6 units hoist. Conformance
All type of the PPE taken by worker from Admin are recorded and signed.
Safety training are conducted.
4. How about chemical store cleanness, tidiness, pails got labeling Chemical store are cleanness.
Conformance
and so on. Label are in place.
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
c) supporting devices (such as transport, communication or Supporting devices are well prepared. There're own transport devices which are 2
information system)? lorries and 1 van to send off the parts to customers, phone in office and internet Conformance
provided.
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
Audit Area: Production Auditee: Vani & LT Ong Documentation No: -
2. Go through the processes to see how is the stage of product Fresh part PMC is checked by IQA and go to production to proceed process by
Conformance
undergoes, what should be checked, by who, any reference, etc. operator Naing Lin. After process will have OQA checking. Eg: PMC/17/9034
3. Any verification, validation, monitoring, inspection and test Monitor, verify and inspec the thickness by thickness tester and record in process
Conformance
activities specified to the product acceptance? traveller. Check the product acceptance through drawing or ask for customer.
8.2
1. Does the organization determine and implement effective Yes. By email, phone and fax. Conformance
communication with customers?
2. Who communicates with customer regrading information on For price information are Mr.JK Ong
products, handling enquiries,orders, obtaining customer feedback/ For shipment /delivery are Ms.Anna
complaints, handling or controlling customer property and For quality issue are Mr.ZZ Ong Conformance
establishing requirement for contingency? For technical support are Mr.LT Ong
Found that Ms.Anna are not so fully understant for the process flow for own job.
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
4. Does the organization conduct a review before commiting to Yes. By email, quotation. Conformance
supply products and services to a customer to ensure the
requirements for product can be met?
5. What happens when requirements for products and services are Chemlite are according to customer requirements.If cannot provide the service will Conformance
changed? reject it.
8.4
1. How does the organization ensure that externally provided The product need to buy are request by engineer. Admin will according to the item
processes, products and services conform to requirement? to order the product. Conformance
refer to the WI-106.
2. Check for retained documented information of these activities Example: Tubular immersion heater buy on 1/8/2017 10pcs, P/O number 601390
Conformance
and any actions arising from the evaluations. SP Chemical 25/5/2017, poly luminium 25kg.
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
4. How does the organization ensure the adequacy of organization Base on the D/O and supplier COC. Conformance
ensure the adequacy of requirements prior to their communication
to the external provider?
5. Does the organization evaluate, select, monitor the performance Yes.Vendor selection assement Conformance
and re-evaluate external provider based on their ability to provide
processes or products and services in accordance with
requirements?
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
2. Is there a procedure or plan to specify all critical parameters yes, Process control plan.
and product characteristics which need monitoring or control?
Check for exp: Zheng yee
Conformance
i) Incoming part specifications Part RG7030 Quantity 110pcs Black anodize
ii) Production specification production date: 19/8/2017
iii) Any equipment used for checking the part thickness tester. MPO dual scope.
iv) Monitoring and measurement activities i.e. Process
Traveler, PCP, D/O or PO or other documents support.
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
4. Where traceability is a specified requirement, do individual According to the incoming part. Follow incoming log book.
Conformance
products or batches have a unique identification? traceability are compliance
i) How to select process traveller number to be unique?
ii) Select at least 2 parts to prove for traceability from Admin
through production until QA or v.v.
Is the traceability compliance or not?
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
6. If any customer property that is lost,damaged or otherwise found inform to customer, to see the part need to return or open credit note. Conformance
to be unsuitable for use, How to handle?
CHEMLITE
AUDIT CHECKLIST
Audit Date: 21/8/2017 Auditor: ZZ Ong & Shanthini ISO Clause: 7.1.3,7.1.4,8.1,8.2,8.4,8.5,8.6,8.7
2. Is the responsibility for review and authority for the disposition yes, engineer will define the nonconforming product. Conformance
of nonconforming product defined?
3. Are nonconforming and suspect products reviewed in accordance yes. OQA report. Conformance
with documented procedures ? And reworked, accepted, regraded,
rejected/scraped properly in consistence with procedures?
Audit Date: 22/8/2017 Auditor: Anna & Vincent ISO Clause: 8.5.3, 8.5.4
2. Who receives parts from customer? Show the related record QA Inspector receives parts from customer. Then QA Inspector chop and sign the
and document. temporary D/O from customer and record in Incoming Log Book to get the CT No
(series number). Then only can issue in process traveller. Lastly, return photocopy
D/O to customer and original D/O pass to Admin. For example:
Conformance
Customer: MDS Advance
CT Number: MDS/17/11424
Date: 22/8/17
Part Number: RG-7002-568-B/A (1 pcs)
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 22/8/2017 Auditor: Anna & Vincent ISO Clause: 8.5.2,8.5.3,8.5.4,8.1,8.6,8.7,7.1.4
4. Any handling precautions to follow? There have different handling precaution to follow based on customer. For example
: The receives parts with already have plastic bag will put back inside plastic bag
again after checking for purpose of protection. Other way is throw the plastic bag
Conformance
and put the parts inside the bubbles pack that already have bubbles pack for easy
to take out. When checking, QA Inspector have wear finger coat to take the parts
to prevent finger print on the surface of parts.
2. Who performs check on the material? Vani (Process Engineer) check on the material based on C.O.O from supplier. Conformance
4. What happen if materials are rejected? Vani (Process Engineer) inform the purchasing (Ms. Goh). Conformance
Audit Date: 22/8/2017 Auditor: Anna & Vincent ISO Clause: 8.5.2, 8.1, 8.6, 8.7, 7.1.4
6. What other stage do QC conduct check on parts to make sure OQA do QC conduct check on parts to make sure they meet requirements.
they meet requirements? What happens when there are non Reject parts and good parts put separately. Reject parts wait Engineering to
Conformance
conforming parts? confirm need to rework. If the reject parts cannot rework, then send back to the
customer to confirm scrap or waive.
7. Who is authorized to release the parts to the next process? QA Inspector and Leader. Process traveller (CT No: UWC(A)/17/9564), (Part No:
Conformance
U9001847)show that inspected by Aruna and approved by ZZ Ong & Kogila in OQA
8. Check the work environment in QC. Have spacious, lightly, good room temperature, have labeling. Conformance
9. Is the QA personnel trained and qualified to perform the F-202 Training Attendance Record show that Faridah (IQA) and Jospin (OQA)have Conformance
inspection? trained on 22/6/17 with Understanding of IQA, OQA process & reject criterial.
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 8.5.3 & 8.5.4
Audit Area: Incoming QA, Production & Outgoing QA Auditee: ZZ Ong Documentation No: -
2. Is the customer property identified, verified, protected and Customer part ,bin or carton were allocated at storage area in the store and were Conformance
safeguarded? locked by store leader at the end of the working day.
3. Check for customer part, tray/bin and etc. eg. Thong Sheng Engineering Sdn Bhd
CT no.: Thong Sheng/17/11417 with date 22/8/2017 Conformance
Remark were written on process traveller, eg. 'with own bin / tray".
4. Where are they stored and protected? The bin/ tray were arranged in storeroom according to customers' name. Conformance
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 8.5.3 & 8.5.4
Audit Area: Incoming QA, Production & Outgoing QA Auditee: ZZ Ong Documentation No: -
Conformance
D.O All Star CT17-11309
Date:19/8/2017
Customer D.O no. PP17-1131
Part no: 034340-01-11pcs
It can be traced to Admin department, where DO no.
CT17081117 is issued on 23/8/2017.
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 8.5.3 & 8.5.4
Audit Area: Incoming QA, Production & Outgoing QA Auditee: ZZ Ong Documentation No: -
Rejected parts were placed in rejected area with signature of authorized personnel.
eg. Wellsentech Sdn Bhd
CT no.: wellsentech/17/9889 dated 25/7/2017
Conformance
Incoming parts quantity: 156 pcs
Rejected parts quantity: 11 pcs with white spots
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 7.1.5
(b) Internal Calibration? Machine calibrated internally according to their expired date.
eg. Rectifier (Palledium Gold Line 1)
Report number: CL508-R8
S/N: PS1200621 Conformance
Internal calibration was done on date 20/7/2017 and expired on 20-10-2017
Master instrument due date: 16/5/2018
Calibration result showed that internal calibration was compliance.
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 7.1.5
(d) External calibration? Instrument/ machine sent for external calibration according to their calibration period.
eg. Procal Services Sdn Bhd
Instrument: Liquid in Glass Thermometer
Calibration date: 16/5/2017
Expired date: 16/5/2018
Conformance
eg. Micro Pioneer (SEA) Sdn Bhd
Machine: Micro Pioneer XRF2000H
S/N: 080709
Calibration date: 22/11/2016
Expired date: 21/11/2017
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 7.1.5
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 7.5
Audit Area: Document Control Auditee: Vincent Lau Documentation No: SOP-101
2. Does the document control procedure ensure that relevant Latest version of documents were available and in used.
versions of applicable documents are available at points of use? For examples,
Check for current revision. F5-1 Rev.00 Forta Plating -Daily Titration, pH and SG Record.
Obsevation
F4-1 Rev.01 Daily Lab Analysis Record for Gold and EN Medium P/High P Plating
Line.
Observation for PCP and SOP not updated on board / wall in production area.
3. Does the procedure ensure that documents remain legible, Forms were easily retrievable from Controlled copy file and were up to date.
readily, identifiable, and retrievable? For example:
Conformance
View some documents to prove it. F1-1 Rev.00 Daily Analysis Record for Anodizing Line
F305-01 Rev.00 Instrument Calibration Master List
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 7.5
Audit Area: Document Control Auditee: Vincent Lau Documentation No: SOP-101
5. Does the procedure ensure that all obsolete documents are Obsolete documents that issued previosly were collected back and the obsolete
promptly removed from all points of issue or use? Master Copy were stamped with "Obsolete Copy".
Obsolete documents were replaced by new documents and distributed to personnel Conformance
related or designated area.
For example: F-101 Rev.00 to F-101 Rev.01 (Audit Checklist)
6. Does the procedure ensure suitable identification of obsolete Obsolete documents were updated in Obsolete Document List stated with revision
documents if they are retained for any purpose ? number and effective date. Conformance
Obsolete Master Copy were stamped with ''Obsolete" and kept for future reference.
Audit Date: 22/8/2017 Auditor: YJ Goh & SF Loh ISO Clause: 7.5
Audit Area: Document Control Auditee: Vincent Lau Documentation No: SOP-101
Audit Date: 22/8/2017 Auditor: Tan Li San / Foo Kathleen ISO Clause: 7.2
Audit Area: Competence Auditee: JK Ong, YJ Goh, ZZ Ong, WC Heng, LT Ong Documentation No: -
2. Any trainings given to the operators at respective departments? -Head of departments have given training to operators at respective departments.
Show evidence. -May Lwin Ko (Gold plating QA operator) attended OQA Defect Criteria on
12/5/2017.
-May Lwin Ko attended operating instruction training on 23/3/2017.
-Mohamad Izham (Production operator) attended Part 1: Safety Procedures and Conformance
Regulations on 23/4/2015.
-Parvathi (Anodizing QA operator) attended understanding of IQA, OQA process
and reject criterial training on 22/6/2017.
-They fully understand about the training given and able to perform on the spot.
Audit Date: 22/8/2017 Auditor: Tan Li San / Foo Kathleen ISO Clause: 7.2, 7.3
Audit Area: Competence, Awareness Auditee: JK Ong, YJ Goh, ZZ Ong, WC Heng, LT Ong Documentation No: -
7.3
1. How does company's quality policy and objectives related to -The company's quality policy and objectives are made based on the ISO 9001:2015
Conformance
QMS? requirements and advise given by ISO consultant to fulfil the QMS.
2. Actions taken when the product quality does not conform with -Head of department will issue CPAR to respective employee that make mistakes.
QMS? -ZZ Ong issued CPAR (CPAR No.: 0164/17/ACM21) to LT Ong on 14/2/2017 Conformance
due to Part #60-01200-01-R colour tone out of control.
3. Do you know what is the company's policy and objectives? -May Lwin Ko, Mohamad Izham and Parvathi understand company ISO 9001:2008
Conformance
quality policy and objectives.
C : Conformance O : Observation N : Non Conformance
Doc.No.: F-101 Rev.01 (Retention Period: 3 years)
CHEMLITE
AUDIT CHECKLIST
Audit Date: 22/8/2017 Auditor: Tan Li San / Foo Kathleen ISO Clause: 7.4
Audit Area: Communication Auditee: JK Ong, YJ Goh, ZZ Ong, WC Heng, LT Ong Documentation No: -
2. How to communicate with customers and workers internally -Via social media, email, phonecalls and message. Conformance
as admin executive?
3. How to communicate internally and externally as QA engineer?-Social media, email, phonecalls, sometimes need to meet customers face-to-face. Conformance
4. Who to communicate when product quality not complied with - May Lwin Ko: Report to Amutha (Department Leader) or WC Heng (Supervisor).
QMS? -Mohamad Izham: Report to LT Ong (Production Engineer) Conformance
-Parvathi: Report to ZZ Ong (QA Engineer), LT Ong (Production Engineer)