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.

Sunday, May 19, 2013

How to Manage an FDA Inspection-Part 1

For everyone involved, FDA inspections are time-consuming and labor-intensive processes, but they needn’t be frustrating or mysterious if a company has prepared properly.The most important preparation is complying with the pertinent laws and regulations, including developing safe
and effective products and implementing an effective quality system. Although compliance is necessary to a good outcome, knowledge of the inspection process and preparation of key players can reduce anxiety and limit missteps associated with inspections.

This article serves as a guideline to help you prepare for an inspection, an-ticipate what FDA may be planning to do, and
develop a procedure for handling FDA inspections.Defining Roles For large companies, there are nu-merous roles to be defined when getting
ready for FDA. But in any company, a minimum of five roles must be delineated ahead of an inspection.

In small companies, one person may hold several of these roles.For any particular facility, there is a most responsible person. This is not a
role that is chosen by the inspection team, but rather is defined by the hier- archy of the company. The most re-sponsible person is the individual with the most accountability for the opera-tions of the facility. In addition, the most responsible person is legally answerable
to ensure that the facility is in compliance. Typical titles of the most responsible person are president, CEO, COO,general manager, or plant manager. The critical functions of this role are to provide leadership and to communicate to FDAthat the company intends to comply with all laws and regulations.

Wednesday, May 15, 2013

Control of Monitoring and Measuring Equipment

Inspection, measuring and test equipment is controlled, calibrated to standards traceable to international or national standards or checked and maintained to ensure conformance of products to specified requirements prior to use. Where no such standards exist, the basis of calibration will be stated on the equipment calibration document.

Accuracy of the required measurement is known and equipment is selected as appropriate to perform these measurements. The measurements to be made are identified by the applicable product/process specification and the appropriate inspection, measuring and/or test equipment is utilized.
All equipment used for inspection, measuring and testing of products are calibrated and/or verified at prescribed intervals. The calibration or verification status of equipment is identified by calibration stickers.

Calibration is performed by qualified and trained personnel, and records of calibration are maintained. Detailed calibration procedures and instruction are established and maintained for both existing and new equipments. Equipment is stored and preserved in a manner conducive to the maintenance of its accuracy and fitness for use.

If equipment is found to be out of calibration, the Quality Assurance Manager is notified and the product inspected on that equipment is reviewed by Quality Assurance with assistance from appropriate departments and any corrective action is documented.

Where test software or hardware is used, it is checked to prove it is capable of verifying the acceptability of product. Procedures establish the frequency and extent of re-checks/calibration.
Outside calibration suppliers are approved and their approval is documented. Only approve suppliers are used for calibration, and these suppliers conform to all applicable requirements in this section. Equipment that does not require calibration is identified with a label where possible. The rationale for not calibrating equipment is documented.

Sunday, May 12, 2013

Statistical Techniques Procedure Template for download-Part 2(Definition)

Sample Selection Techniques
In order to ensure a bias free sampling the sampling selection must be random, the sample selected should be a representative sample that can be expected to adequately reflect the properties of interest of the population in question.

Stratified Sampling
A stratified sample is obtained by taking samples from each sub-group of a population. With this approach, an equal number of samples are taken from each tray, bin or any other similar division of product.

Cluster Sampling
Cluster sampling is a sampling technique where the entire population is first divided into groups, or clusters, and then a random sample of these clusters is selected.

Periodic Sampling
A periodic sample is taking by selecting every nth unit from a lot/batch or run. When selecting this approach care must be taken not to select a period that is in line with the period of the process.

Confidence Level
The confidence level expresses in terms of a percentage that what is being rejected by the plan merits such rejection.

Confidence Interval
A confidence interval is an interval with an associated probability p that is generated from a random sample of an underlying population such that if the sampling was repeated numerous times and the confidence interval recalculated from each sample according to the same method, a proportion p of the confidence intervals would contain the population parameter in question.

AQL (Acceptable Quality Level)
An acceptable quality level is an inspection standard describing the maximum number of defects that could be considered acceptable during the random sampling of an inspection. It is generally defined as what the sampling plan will accept.

RQL (Rejectable Quality Level)
Also known as LTPD (Lot Tolerance Percent Defectives), refers to the level of quality routinely rejected by the sampling plan. It is generally defined as what the sampling plan will reject.
Normal Data

Normal data are data sets that come from a population that has a Gaussian distribution or bell-shaped distribution governed by:
Common Cause Variation
Common cause variation is a source of variation that is normal and expected throughout the life cycle of the process. Common cause variation is inherent to the process and is predictable.
Special Cause Variation
Special cause variation is a source of variation that causes a fundamental change in a process. Special cause variation signals that an abrupt change in the process has occurred. Usually this type of variation is unpredictable can be traced back to a source.

An outlier is a data point that is numerically distant from the rest of the data. Outliers can be attributed measuring errors, errors in data transmission or transcription, or instrument error. All outliers should be investigated to determine their cause before eliminating from a data set.
Go-no Go Gage

A measuring instrument that determines whether a feature either fits or does not fit therefore aiding in the decision of whether it passes or fails the inspection. Usually, no effort is made to determine the exact degree of error.
Root Cause Analysis
A study undertaken with the purpose of finding the underlying cause of a problem. Root cause analysis involves the collection and study of data to determine the true cause or causes to a problem.