Quality Improvement Activities

ISO9001:2000 insist on having quality improvement program in the organisation. This is to assure there will always be continual improvement to maintain the system and assist in boosting the employees morale. Improvement activities normally involve teamwork, and such encourage the participation of the employees from bottom up. Except maybe ESS (employee suggestion scheme) which individuals can contribute to the improvement program, most activities such as 5S, Kaizen, QCC(Quality Control Circle), TQM (Total Quality Management), Benchmarking, JIT (Just In Time system), Six sigma, Lean Management, ERP(Enterprise Resource Planning) and etc. The above activities has been develop for years, it range from simple low-tech activities to high-tech big budget investment from the organisation, which both hope to gain return of investment through reduction of waste, product rejects by utilising the resources and increase the sales by the increase of customer satisfaction. These will contribute to the bottom line and that eventually lead to business growth and sustainable business.
However to ensure the success of this program, improvement activities must be consistent. The top management must play a crucial role to support and be involved in the program. One way to encourage the employees participation is through insentive program or an additional bonus in their yearly appraisal for those who involved in the program apart from doing their core job. There're more success stories found in other businesses and can be apply in your own organisation, however, we need to ensure high quality of human resource, more RELEVANT training can coaching must be given to ensure employees are able to contribute continually to the program.

Why product quality is important?

The comic illustrates the why quality control is crucial especially when safety criteria is involved. Most people thought that quality of product is the least important agenda for the manufacturer, however is it the priority of all end user. We expect good product because we pay to get a good product. If we don't get it, we either complain, never return to the supplier or request for refund. Either way, the manufacturer or supplier will lose customer confidence and sales in the long run.The demand is even greater now that tainted milk product found in China dairy product has lead to their consumers health hazard. The government and private organisation is striving even more fervently to tighten the products quality control. Public awareness on product quality has increase through media and internet exposure on (food) products quality. Therefore more consumer will choose to go for products that has Quality certification for example UKAS (United Kingdom Accreditation Service, ASQ(American Society for Quality), Japan Quality Association (JQA) and SIRIM (Standard and Industrial Research Institute of Malaysia) and etc. For HACCP (Hazard Analysis Critical Control Point) certification, it is accreditated by the accreditation bodies such as the above mention. The HACCP is a systematic analysis to identify food hazard and it is an important measures to ensure food safety assurance. So next time when you shop for home essential, please ensure your product is certify by genuine certification bodies.

Quality Improvement - 5S

What is Quality without continual improvement, one method to include in the improvement project will be the 5S projects. It could be simple as housekeeping activities to more refine such as conducting monthly audit and award system. Either way it works toward achieving quality workplace.
5S practice is a technique to establish and maintain quality environment in an organisation. The 5S's are a group of techniques to promote workplace organisation, ensure adherence to standards and foster the spirit of continuous improvement.

Principles/ Key Attributes
To successfully convey the message of 5S across the organisation, achieve total participation and systematically implement the practice, establishing effective quality processes as pre-requisites for good products and services, the following step-by-step approach should be adhered:

• Organisation (Seiri)

The objective of organisation is to get rid of unwanted items by focussing on the core items that are needed to fulfil the requirements of the job and discard items that are not needed. This could focus on the elimination of excess inventory affecting, warehouse space, transportation, labour costs, needed items, and redundant parts, for example.

• Neatness (Seiton)

Neatness focuses on efficiency, with the main objective being on how quickly one can get the things needed and how quickly those things can be put away. This is achieved through locating a specific place for specific items of a specific quantity, where needed.

• Cleaning (Seiso)

The objective of cleaning is to identify abnormalities and areas for improvement. This is achieved through a combination of cleaning the workplace and at the same time focusing on the identification of abnormalities or out of control conditions.

• Standardisation (Seiketsu)

The objective of standardisation is to consolidate the first 3 S’s by establishing standard procedures. This activity is carried out to determine the best work practices and find ways of ensuring that everyone carries out an individual activity the same ‘best’ way.

• Discipline (Shitsuke)

The objective of discipline is to sustain improvements and make further improvements by encouraging effective use of the ‘Check-Act-Plan-Do’ cycles. This is achieved through strict adherence to current improvements and the development of an environment for future improvements.

The Impact on functional Activities
The approach embodied with 5S will effect everyone and everything within an organisation. The technique of 5S begins with a promotion plan for the sole purpose of promoting the establishment of the 5S’s. This incorporates everyone within the organisation from the highest level to shop floor level consisting of a blame-free environment. To instill all viewpoints at each level a steering committee is formulated and is responsible for the implementation of 5S.
The next stage is Awareness Training focusing on the dissemination of the 5S plan and its objectives and incorporating suggestion schemes for the ‘buy-in’ of all employees. An Internal Audit highlighting areas for improvement.

What are NCRs?

What is the point to have a quality control in the process if the top management tend to overwrite their decisions? Like in the comic-strip?Non-conformance Reports or issues of reports when a company, process or auditees does not follow the documented procedures which could lead to customer dissatisfaction. The reports will contained the type of non-conformance, where the problem occur, who in charge of the process, when the problem found. The auditor will hand over the NCR to the auditee/QMR and the auditee/QMR will need to reply the NCR within 2 weeks. They will need to state the corrective action taken to rectify the issues.
NCR is initiate in order to prevent further damage on the products. So it is better to avoid unneccessary rejects and get a return sales from happy customer.

Many faces of auditors

Auditor Grades

There are five grades of certification, most auditors progress from provisional auditor to the auditor grade and then to either lead or principal grades (these last two are considered the most advanced grades). The internal grade is a specialist grade but many auditors use this as a starting point before moving to the other grades.

A specific description of each grade within the criteria for each auditor is summarized below:

Internal Auditors

• Are those who conduct internal audits of their organization's management system.
• Recognizes: personal attributes, education, professional and technical competencies

Provisional Auditors

• Are entry level/trainee auditors seeking a career in auditing and experienced auditors taking a break from auditing or moving into management
• Recognizes: personal attributes, education, professional and technical competencies

Auditor

• Are audit team members
• Recognizes: auditor competence and contribution as an effective member of an audit team

Lead auditor

• Are audit team leaders who typically work for certification bodies or perform supplier audits for large organizations
• Recognizes: competence at managing audits and leading teams

Principal auditor

• Are experienced auditors who operate on their own (i.e. as a team of one, performing sole audits). We designed this grade as an alternative to the lead auditor grade
• Recognizes: experience and competence of two categories of auditors:

1. consultancy background: competence in implementing management systems and performing all aspects of the audit process
2. lead auditor background: competence in audit management and team leadership

How should you answer an auditor?

I am sure auditors are the most unwelcome visitors everywhere, the management thinks the whole reason for them to conduct audits is just to find problems, and employees has a hard time to keep up with the backlog and incomplete documents/records. But there shouldn't be a problem if all procedures is in place and updated. The most important part is the QMR or Quality Management Representatives. They are not the people who should do all the nitty-gritty stuffs, but they are the ones who should lead the internal audit team, have a run through with the management staffs on the quality plan and improvement activities. The critical part will be she/he should know how to deal with and auditors.
I have deal with many auditors before, lady and men alike, they are great people if you both understand what they need. Here are few tips on how to do just that:

1. Make sure you let the process owners are available to answer the technical questions, don't try to answer if you have limited understand on that field.
2. Make sure all records are easily available.(The critical processes records such as critical records, Management reviews, Internal Quality audit, Control of document, production/service control)
3. Be honest. If the records are not available, just let the audit know about it, the auditors are human and they would accept if the records is used as reference in another factory, customer site and etc, they will appreciate it more rather than having to keep them waiting for non-existing records.
   
4. Normally auditors can use another records to verify the process. SO if you don't have exact record they need, you can suggest another method you use for the process. Some company they don't use bulky training records instead they use matrix charts or training lists.
5. Share information with you auditors, ask for advices on how to improve the quality process which applicable to your sites, it is not a sign of weakness, rather it is merely discussion between professionals who strive for continual quality. This way the auditors will be more lenient, in a way, you show that the company is keen to embrace change and improve the process for customer satisfaction.

Just remember, try to put yourself in their shoes. If you are a good Internal auditor in your company, you would be a good auditee for the external audit. SO it is advisable to send the company's process for an internal quality training course, or better yet, appoint them as the internal auditor.

Common Questions during IQA

I've been doing alot of presentation on how to conduct IQA, sometimes old habit die hard, I tend to be technical with the jargons, so since my posting is derived from my presentation, I hope I can enlighten you with the audit methods.

When you come to the place to audit, introduce yourself and inform your auditee the reasons for the visit. DO not intimidate your auditee, auditee suppose to assist the auditee and not find faults on the audit site. (You should have with you, Quality Questionnaires and Quality plan)

Here's are more example on questions you may ask during your audit?

1. Do you know what is the company quality policy? (make sure the policy is visually display)
   
2. Do you know how to operate this machine? Can you show me how to conduct quality check/test?
3. Where's the quality tools? (check if the tools have proper identification, calibrated & easy to access)
4. Where is the SOP? (Check if the SOP has validation, updated and easy to understand)
5. Do you go through any training? (check his training records to verify)
6. Where are your checklist?
   
7. How often do you check the item?
8. If you are on day off, who take over your job as operator/QC checker?
9. Who is the QMR?(we need to ensure quality is communicated throughout the organisation, from top down)
   
10. other relevant questions.

Remember to cross reference with records or other employee to verify the answer.
Once the audit is done, thank the auditee and do share some improvement activities for the site too.

What about IQA reports?

How to write report?

A report proforma has been designed to help identify the areas which should be commented upon.

The full draft audit report will be circulated and will be confidential to the following people:

• the Audit Team;

Once the full Audit team has confirmed the report, the report will be circulated to:

• the Auditees, i.e. the owners of the process that has been audited. This will give them the opportunity to comment on the factual accuracy of the report.
• the President
• HOD or the responsible personnel for the audited area*
• the manager responsible for the audited area (if not an Auditee)
• the Auditors
• Internal Quality Audit Committee

The audit report should:

• document what occurred during the Audit visit
• be congratulatory where appropriate
• include examples of good practice
• identify where procedures need to be written and followed
• should encourage the Auditees to do better where appropriate
• Always include specific objective evidence
• Run NCR/CAF pass auditees before you present them formally.
• Once you have written a NCR/CAF, ensure it is fair.
• Do Not raise NCR/CARs on unsolvable problems.

The Head of department should be given the opportunity to respond to the contents of the report within 5 working days of receipt of the report.

How to Evaluate IQA Findings?

Evaluation of results/Audit Findings

Categorization of Non-Conformance: this is to allow an organization to priorities its correction and prevention efforts in an effective manner.

Major non-conformance

• An element of the standard is not addressed. (e.g. No manual, no policy, no significant procedure manual)
• An activity, which is in direct contravention of standard.
• An activity, which is in direct contravention of a procedure and could have significant effect on product and service quality.

Minor Non-conformance

• An isolated incident of a non-conformance with a system or procedural requirement with no direct consequential effect on product/service quality.
• Trends of minor non-conformance could lead to major non-conformance if more than 3 incidents of the same deficiency are encountered.

Observation

• Comments on the quality system with a view to improvement.

What do you do during audit?

Documentation : Checklist

Six steps for developing process checklists

Step 1: Consider the overall business goals.

Step 2: Review the core process(es) and required outcomes

Step 3: Review of any documentation relevant to outcomes.

Step 4: Establish process issues critical to outcomes

Step 5: Prioritize the points.

Step 6: Prepare the checklist

The Audit Visit:

The Auditors will normally visit the Auditees on their 'home territory'.

The Auditors should be:

• Clear on the aims of the audit
• Clear on the Scope/boundaries of the audit
• Polite at all times
• Courteous
• Confident
• Well prepared
• Thorough

The Audit Visit: Stage I Audit

• Will look at the process as presented by the Auditees and whether or not:
• the Auditees follow the process as presented
• the Auditees understand the process as presented
• the Auditees recognize the process as presented
• the Auditees find that it works

• Where there is no documentation the Auditors should ask for an oral account of the procedure(s) that are followed for the particular process being audited. In such cases the audit report will include a strong recommendation that the procedures are documented.

• If there are 'Service Standards' connected to the process or function they should be uncovered, but not imposed if there are none to begin with.

The Audit Visit: Stage II or Follow-Up Audit

• It is expected that, by this stage, the process has been documented, so the audit will look to see if the process is being followed as stated by the staff that use it.
• The audit will also look for continual re-evaluation of the working practice and procedures and any improvement necessary. In addition the Audit will ensure that all staff involved with the process have understood and incorporated any changes made.
• The ability of the staff to reflect on their work should be aided by the independent and unprejudiced nature of Internal Quality Audit.
• Auditors when making their visit should take into consideration the Company’s Plan where that plan contains targets pertinent to the process being audited.

Conducting audit:
Audit techniques/communication

• 7% Verbal

What was said

• 38% Vocal

How it was said; pitch, rhythm, enthusiasm

• 55% Non-verbal

Body language, gestures, culture, personalities, space and setting, word meanings, emphasis and punctuation

Non-Verbal Actions

• Positive Non-Verbal Actions
• Leaning Forward
• Eye contact
• Facing the person
• Relaxed posture
• Negative Non-Verbal Actions
• Leaning away
• Avoiding eye contact
• Standing above or behind auditee’s (confrontation)
• Standing/sitting too close
• Sitting on auditee’s work bench
• Carrying clipboards
• Loud emotive tones
• Threatening gesture
• Pointing directly at auditee’s

What else???

• Effective listening
• Hearing is not listening
• Aids to effective listening
• Use attentive body language
• Learn to use your thinking time wisely
• Become an observer (control your mouth)
• Listen with open mind
• Listen all the why through (don’t make assumption)
• Effective Observation
• Observation must be substantiated with objective evidence.

More about Internal Audit

Pre-Audit: Audit scope identify
The scope of an audit relates to what will actually be audited. It is the extent and range of a given audit and could include:
• Organizational process, activities an product.
• Organization units, departments and work environments
• Group of people
• Physical locations
• Documentation

Pre-Audit: Audit team selected
• Management responsibilities
• An auditor is a person qualified and competent to conduct audits. (Training,Independent, appropriate knowledge of activity being audited)

Pre-Audit: Initial Audit planning meeting
• Prior to the commencement of the audit, a range of information needs to be discussed and confirmed with the auditee.
• Factor to consider in initial contacts with auditee.

• Objective, scope, criteria, feasibility
• Availability, timing, Timetable.
• Auditee Contacts, audit team, resource
• Approach, documentation required.
• Previous audit results, outstanding Non-conformance.

Audit Plan: Timetable
Factor to consider:
• Process and Activities sequences/complexity of process/product.
• Important of activity risk/need for competency
• Infrastructure and Organizational layout.
• Work start/finish times.
• Physical locations
• Employee numbers
• Documentation;Number of procedures/Relevance to ISO 9001
• Schedule meetings with auditee/audit team

Pre-Audit: Documentation submitted and circulated to audit team

• Manual
• Documented Procedure
• Process maps
• Previous NCR/CAF

What to do during Internal Audit?

What is Internal Quality Audit?

Known as 1st party audit whereby the company aim to provide a mechanism for ensuring conformity to the quality system and to assist in the ongoing improvement to the system.

What is the objectives?

1. Record the approved procedure (this protects it against the unexpected such as sudden illness)
2. Ensure the approved procedure is followed
3. Question existing procedures - has the context within which the procedure operates changed enough to make a revised procedure more effective and efficient?

What are the requirement for an audit?

• People
• Documentation
• Process

People

The internal audit should conducted by competent team and lead by skilled Internal audit Lead auditor. How to ensure this by having all the team member to attend Internal Audit Training. The lead auditor should has experience with quality assurance background, preferably has attended the Lead Quality Auditor/ Accessor course.

Characteristics and skills which are important in the auditor role:

• being a good listener
• being articulate and having good written and oral communication skills
• being confident
• paying attention to detail - but not ‘nit-picking’
• being rigorous - but not antagonistic or aggressive
• being sensitive and approachable, able to put people at ease
• being systematic
• being patient
• being courteous having a commitment to quality development

Documentation
1. ISO 9000:2000
Structural of new standard

• Clause 4 : QMS
• Clause 5 : Management Responsibility
• Clause 6 : Resource Management
• Clause 7 : Product realization
• Clause 8 : Measurement, analysis and improvement.

(Refer to Malaysian Standard : MS ISO 9001:2000)

2. Objective Evidence
Data Supporting the existence or verification of something.

Objective evidence may verify:

• That specific requirements have been fulfilled.
• That requirements for specific use/application have been fulfilled.
• Suitability, adequacy and effectiveness to achieve established goals.
• Format may include hard or softcopy documentation, forms, record, verified statements of fact, observations or other information relevant to the audit.

Process of collecting objective evidence is two stages.

Obtain Information ---->Verify Evidence

For example, when you need to check on employees competency, you can interview both the QMR and auditees. They will provide you with the information verbally. That is called "obatain information". But you need to confirm the information given to ensure it is documented and valid, therefore you need to check the employee information agains his/hers training record, you will also need to ensure the records are updated and checked (signed), the second process is called "verify evidence".

Process:

1. Identify Audit Scope
2. Select Audit team
3. Plan Initial audit meeting
4. Audit team briefing
5. Audit visit
6. Feedback from auditees during visit
7. Report to auditee for comment
8. Confirm report
9. Feedback of report from auditees

Once you have conducted all this, it should be easier to handle the internal audit.