Wednesday, August 12, 2015

More ISO 9001:2015 latest revision free training and seminars

A lot of training sessions , briefing and workshop carried out starting last month on wards in Malaysia to introduce quality personnel around the world on the latest ISO 9001:2015 revision. Among the sessions, there were in depth explanation and also a few which just like a briefing session discussing the main changes on the latest revision of ISO 9001:2015 standard which have been drafted quite some time by the committee. Transition from 5 years to revise the standard now become more than that.

Anyway the most important thing is not just the main big changes contain in the lastest ISO 9001:2015 revision but also the impact that going to happen.There were so many questions to address. Does it impact our factory operations/plant? does it impact our cost? Does it impact our resources?Does it impact any legal/regulations? Does it involved new additional training to my company to fulfill the requirement? All these questions pop out.

To get all the information there were many ways. You can go for free training by SIRIM from link here:  Free ISO training for ISO 9001:2015

Or in the other hand you could just go for paid one. Example from BSI which i found it below. Its quite cheap and reasonable. BSI, im promoting this, i think i should get paid a little money here. ;)

Enjoy our special offer 2-for-1 admission.
Seats are limited.
Do not wait any longer and book your seat now!
Date: 18th September 2015 Time: 0830 - 1230
Venue: Armada Hotel, Petaling Jaya Price: RM60 and
Receive a second free registration

Wednesday, August 5, 2015

ISO 9001: 2015 draft is now finalized

Final draft of ISO 9001:2015 is out. Last year SIRIM had similar seminar on final draft of the ISO 9001:2015 changes. Now the standards is finalized and it is no more called final draf 2015 but it is a new revised ISO 9001 standards. The main changes in ISO 9001:2015 are the adoption of the HLS as set out in Annex SL of ISO Directives Part 1. An explicit requirement for risk based thinking to support and improve the understanding and application of the process approach. Fewer prescribed requirements. Less emphasis on documents.Improved applicability for services. A requirement to define the boundaries of the QMS.

Others, there were increased emphasis on organizational context, increase leadership requirements and finally greater emphasis on achieving desired outcomes to improve customer satisfaction.

There were briefing organize by SIRIM for free of charge to have a better understanding on the new changes. You may refer to below location, venue and date as adressed.

Location: Penang
Venue: The light hotel, Seberang Jaya
Date: 5 August 2015 (Wednesday)

Location: Johor
Venue: The Puteri Pacific Johor Bahru
Date: 12 August 2015 (Wednesday)

Location: Klang Valley
Venue: SACC Convention Centre Shah Alam
Date: 13 August 2015 (Thursday)

Location: Klang Valley
Venue: SACC Convention Centre Shah Alam
Date: 18 August 2015 (Tuesday)

Location: Sabah
Venue: Grand Borneo Hotel, Kota Kinabalu
Date: 26 August 2015 (Wednesday)

Location: Sarawak
Venue: Pullman Kuching
Date: 27 August 2015 (Thursday)

Location: Pahang
Venue: The Zenith Hotel, Kuantan
Date: 3 September 2015 (Thursday)

Monday, July 27, 2015

ISO/DIS 9001 - OPERATION - Determination of requirements for products and services - Customer communication

Requirements in clause 8.2.1 of ISO/DIS 9001 are similar to clause 7.2 of ISO9001:2008 QMS standard, however now organization needs to establish the processes for customer communication. As per requirements of ISO/DIS 9001, the organization needs to establish processes for communicating with customers for - products and services information, - enquiries, - contracts, - order handling, - changes with regard to enquiries, contracts, order handling, - obtaining customer views, - obtaining customer perceptions, - obtaining customer complaints, - handling of customer property, if applicable, - handling treatment of customer property, if applicable, - contingency actions' specific requirements, when relevant. Effective customer communication plays a important role in all above activities. Make sure that the organization understand the importance of customer communication. The organization can meet customer's requirements in a better way when it has effective customer communication processes. Effective customer communication can be done by establishing processes for providing product information, catalogues, specifications, samples etc. Product information may also be communicated in hard copy or soft copy. For handling enquiries, contracts, order handling and obtaining customer's views, perceptions, complaints, the organization must establish processes for dealing them. ISO/DIS 9001 has also included the significance of establishing processes for handling and treating customer property and also for contingency (a future or possible event or circumstance which is possible but cannot be predicted with certainty) actions.

Tuesday, January 20, 2015

ISO 9001:2015

I attended  ISO 9001:2015 seminars held at SIRIM somewhere end of last year 2014. It is not yet a final draft of ISO 9001:2015 standards revision, however it is already been around paid seminars and training provided by companies to get some money from the updates. Mostly sharing the draft standards of ISO 9001:2015.

Even though it is ISO 9001:2015 draft, a lot of speakers and trainers said the content of the draft going to be finalize and the updates will be at least not different from the final draft.

Sunday, August 25, 2013



Day 1 ( 29 November 2013,)
Venue:  Conference Room
SIRIM-QAS auditor:   4 auditors – days
                                      (Lead Auditor)
                                     Auditor 1, ( Day 1 only)
                                     Auditor 2 (Day 2 only)

 Please refer to attachment for the audit plan from SIRIM-QAS

Time :  All mentioned members should gather at 9.25 am for opening meeting.
9.30am  - 9.45am  

Opening meeting

9.45 am~10.00am

Briefing on the organization’s QMS and changes since last audit

 10.00am ~10.30am
Review of documentation against requirements of ISO 9001:2008. Review of previous non-conformities (if any)
 10.30am ~ 13.00 pm
Measurement analysis and improvement
·         Internal Audit,CAPA and continual improvement.
Customer communication
·         Customer complaints & data analysis
·         Customer satisfaction & data analysis
Purchasing process
·         Purchasing process
·         Suppliers/Sub-con evaluation/re-evaluation
·         Raw material store
·         IQC-verification of purchased products (including on non-conformance products)
13.00pm ~ 14.00pm
Lunch break
14.00pm ~ 16.30pm
Production audit:
Manufacture of Enamelled Magnet Wire and Extruded Insulation winding wire
·         Product realization-quality plan, process, document, verification & validation, inspection & testing records
·         Production control-work instruction, equipment, records
·         Identification and traceability
·         Customer property
·         Control of monitoring and measuring equipment
Customer related process
·         Customer requirement, contract/order review
·         Changes of order
·         Production planning
·         OQC, Finish Good Store including delivery
16.30pm ~ 17.00pm
Review Day 1 Findings
End of Day 1 audit

Day 2 ( 30 November 2013,  )  



 Management Responsibility

·         Management commitment, customer focus, Quality Policy and Quality Objectives

·         Planning, Responsibility, authority and communication

·         Management Review

Human Resource Management
·         Competence, training and awareness
·         Recruitment
·         Preventive Maintenance
·         IT
Lunch Break-Friday Prayer
Session with top management
Control of document
Control of records
Preparation of report
Closing meeting: Presentation of Findings and Recommendation
End of Audit

Sunday, May 26, 2013

Supplier system audit check list

For Supplier system audit check list on Quality Management Practice you can always check below:

No. Check Item/Details Score Judgment Point 1-1
 Quality Policy Clarification and Enforcement 5 ・Quality policy is continuously documented, the method of document distribution and announcement are defined and understood by all employees. ●If there is company quality policy ●If quality policy is documented continuously(Check for 2 years) 4 ・Quality policy is continuously documented. The method is not defined but enforcing understanding to the employees with document distribution and announcement. ▲If there is a defined system to make employees understand 3 ・Quality policy is continuously documented. They are trying to enforce the understanding to all employees by defining the method, but has some inadequate area such as disclosure is located at the place where is hard to see by employees ▲If they are conducting document distribution・announcement etc. 2 Quality policy is not continuously documented. There are only verbal announcement or something like slogan in bulletin. 1 ・There is not even slogan and has no bulletin for Quality 1-2 Quality Control Organization・Personnel 5 ・There is separated and independent QC dept. and QC manager and person in charge (each inspector) are clarified. ●QC organization, QC manager and person in charge (each inspector) are clarified 4 ・There is separated and independent QC organization and QC manager and person in charge (each inspector) are clarified, but QC manager has other responsibilities at different department. ▲If authority is given to the quality manager ▲If there are activity by separated and independent organization 3 ・There is separated and independent QC organization, but QC manager has other responsibilities and responsibility and authority are not clarified. 2 ・Quality control organization is not separated and person in charge also have other responsibilities 1 ・No quality control organization and no person to do quality control 1-3 Quality Control Education・Training 5 ・Education and Training system regarding quality is clarified, they are documented and conducted as scheduled, and its record is retained. ●If education and training system regarding quality is clarified 4 ・Education plan is documented, but the portion of record are not conducted and can't be seen. ●If implementation plan of education and training is documented 3 ・There is no plan for education and training, but they are conducted and its record is retained. ▲If there is education・training record ▲If conducted as plan 2 ・Education・Training plan are documented, but not conducted 1 ・No plan for education・training, and not conducted 1-4 Quality Goal Setting 5 ・Quality goal is set with specific number periodically at each department and employees understand them from document distribution or bulletin board ●If quality goals are set with specific numbers (more than once a year?) 4 ・Quality goal is missing some details, but it is set-up periodically for each department and measure to seek understanding is conducted. ●If there is quality goal for each department 3 ・Quality goal is documented with specific numbers periodically and seeking understanding from employees with document distribution and bulletin board, but there are unsatisfactory matters such as bad bulletin board location. ▲If quality goal is distributed and displayed in writing and employees understand them 2 ・Quality goal is documented, but it is not set-up for each department, specifics are missing, and they are not in the condition to say understanding to the employees are conducted. 1 ・NO quality goal and no bulletin in place of goal 1-5 Quality Implementation Plan and Practice 5 ・Specific action plans based on current condition at whole company and each department are created and implementation progress control and goal achievement are conducted without fail. ●If there is detailed action plan for each department in order to achieve quality goal 4 ・It is unsatisfactory as the plan based on current situation understanding and analysis, but specific action plan is created at whole company or each department and implementation progress and goal achievement are controlled. ●If action plan is created based on current situation 3 ・Action plan is created at whole company or each department even though specifics are missing, and progress control is conducted. ▲If there is record which shows action plan was conducted 2 ・Action plan is not created, but activity to achieve goal is conducted. ▲If the progress of plan and performance is controlled with specific numbers 1 ・No implementation plan and not conducted 1-6 Quality Meeting Implementation 5 ・Periodic quality review meeting is held with management or quality manager attendance and meeting minutes are created and retained. ●If implementation of quality meeting is defined (Attendees, subject, schedule etc.) 4 ・Quality meeting is held periodically and meeting minutes are created and retained, but management and quality manager's unattendence are noted many times. ▲If quality meeting minutes are created and retained. 3 ・Quality meeting is held with management or quality manager's attendance, meeting minutes are created and retained, but conducting meeting is not on specific schedule ▲If quality condition or issues are clarified and review with data 2 ・Implementation is the level of reporting to the management at other meeting such as management review and there are very few record of quality review in meeting minutes. ▲If management is attending or confirming review details 1 ・There is no place for quality review 1-7 Quality System Review・Confirmation 5 ・Confirming periodic confirmation of standard documents and work implementation condition is documented, conducted as defined, its records are retained, and manager or quality manager approves its details. ●If confirmation method and details of standard documents and quality activity conducted by management are clarified 4 ・Periodic confirmation of standard documents and work implementation condition are defined and conducted, but record details are not completed. ●If implementation of periodic review and confirmation is defined 3 ・Documentation is somewhat unsatisfactory and has no approval of management or quality manager, but they are conducted as defined. ▲If there is implementation record 2 ・It is documented to confirm periodically, but not conducted accordingly ▲If is approved by management or quality manager 1 ・Not documented or conducted 1-8 Quality Improvement Circle Activity 5 ・Circle activity which conduct quality improvement is active continuously and its activity record is created and retained. ●If circle activity which conduct quality improvement is active 4 ・Continued quality improvement activity such as circle activity is conducted, but contents of activity record is not completed. ●If it's continued activity ▲If there is activity record 3 ・Quality improvement activity such as circle activity is conducted and activity record is created, and retained, but it is not continued activity. 2 ・Activity is only conducted when problem rise, even with quality, but daily improvement activity is not conducted. 1 ・No improvement activity such as circle activity conducted 〔Question Classification…●:Rule Point、▲:Implementation Point〕

Saturday, May 25, 2013

How to Manage an FDA Inspection-Part 2

Another role, one that must be chosen by the inspection team, is the FDA escort. This role is key to the success of an inspection. The escort should be familiar with the everyday operation of the facility, know who will have the answers to FDA’s questions, understand FDA’s legal authority, and understand the company’s policies regarding specific situations (such as signing affidavits). The escort should be prepared to accompany the investigator at all times. The escort’s job includes meeting the inspector’s needs, guiding the inspector to appropriate subject matter experts, and communicating internally how the inspection is progressing.

When FDA asks for something that the company is not prepared to provide, it is best to have defined ahead of time a person who can explain the company’s policy on such matters. An example of an FDA request that is often denied is the reading and signing of affidavits by company personnel. Explaining a denial is best done by a person who has high ranking in the organization, but is not the
most responsible person nor the FDA escort.

Naturally, any denial of an FDA re-quest should be reviewed ahead of time by legal counsel and is easiest to handle if the company’s policy is contained in a written procedure. In addition, one or more subject matter experts (SMEs) should be defined. These are the specific individuals who will be called upon to answer FDA questions. A list of all SMEs with their areas of expertise
and authority should be created and updated as personnel change.

Each expert must understand the expectations associated with participation and availability during an FDA inspection. Role-playing before the FDA inspection is helpful to prepare SMEs for the types of questions they are likely to be asked. Preparing SMEs and ensuring the list of SMEs is accurate are some of the most highly leveraged preparation activities a company can undertake. It will also be necessary to have one or more designated FDA runners. Among other tasks, runners locate documents, find SMEs and tell them when to appear, and notify department managers if FDA is entering their areas. It is not hard to sell the role of FDA runner when the chosen persons understand they will be in the know about the FDA inspection.