IA Catchwords– Series 10

Outsourced processes control

Process outsourcing has been considered to be an extended arm of any organization, in view of specializations that have set in the various industries. Those processes are well knit in any company’s product/service profile.

Hence, auditing an outsourcing process, is as good and important as any the running processes

The following requirements are to be ensured while auditing outsourced processes

·         Identification of those processes/activities in the Quality Manual

·         Identification of the outsourced process stages, as an integral part of the overall product/service realization – either as a process realization flow or as a quality /process plan

·         Identification of scope of each of those processes, with respect to the products/services rendered by the company

·         Scope shall include list of activities to be carried out by the outsourced agency, and records to be maintained

·         Establishment of control mechanisms to each one of those processes, shall be defined and documented

·         Control mechanism shall to include the 5W and 1H and the applicable QMS clause numbers- activity wise

·         Controls shall include pre-qualification, periodic monitoring & controlling, and re-evaluation

·         Records of the controls shall focus on the process outputs- stage wise, and in line with the requirements of the QMS

·         Controls shall be comprehensive and to include the QMS processes which are common to all the processes, such as control of documents, control of records, defining responsibilities & authorities, control of NC products, etc.,

·         Controls shall include maintenance of records, including the monitoring & control of the processes

·         Control shall include Internal Auditing of the processes, including planning, scheduling, conducting, recording, and follow up of the processes

·         Management review shall include the results of the outsourced processes , with decisions and actions

Comprehensive students' evaluation system

COMPREHENSIVE AND EFFECTIVE EVALUATION SYSTEM IN EDUCATIONAL INSTITUTIONS

 Preamble: Every institution carries out internal examination/class test in order to evaluate how far the student has understood the portions covered by the teacher/faculty. On completion of the class test, each faculty collates the data pertaining to his/her subject, identifies the failed students, in order to provide additional coaching/counseling. Additionally, this evaluation also provides actions to be taken on the students’ performance before final examination in order to ensure that the “failed” students get thro’ the same.

Process: A simple process given below, using the collated data by the faculty makes a comprehensive system to measure the performance of the students in relation to the overall class performance and to evaluate the performance of the individual faculty

Performance evaluation of the students

o   Compile the marks scored in the class test student wise- subject wise in MS-Excel sheet

o   Grade the marks under the following groups

o   > 80%- Very Good

o   60-79%- Good

o   50-59%- Satisfactory

o   < 50%- Poor

·        Calculate the average score

·        Assign the Grades A, B, and C as given below

·        Take the following decisions for students, based on the above

o   If the individual score is > the class average score- GRADE A

CONGRATULATE/MOTIVATE

o   If the individual score is < than the class average score, but >  minus 5% of the class average score- GRADE B- MOTIVATE the student

o   If the individual score is < the minus 5%, but > than minus 10% of the class average score- GRADE C-  COUNSEL the students,  give special coaching classes and watch the next exam score

·        Performance evaluation of the faculty

·        Calculate the number of Grades A, B, and C

·        Take the following decisions for the Faculty, based on the above

o   If the % of Grade A students is more than 70%, the Faculty is to be CONGRATULATED

o   If the % of Grade A Students is between 50 to 69%, the Faculty is to counseled for improvement

o   If the % of Grade A Students is less than 50%, the Faculty is to be counseled for improvement and identified for further training

Inference:

·        The above system identifies the following requirements in respect of faculty

o   Changes in lesson plans

o   Changes in teaching methodology, use of audio-visual teaching aids, etc.,

o   Identification of faculty training requirements, much more effectively- looking from the perspective of the students

Measurement of effectiveness:

o   For Students- measure the Grades for each cadet for all the subjects to get an overview of the academics

o   For Faculty- combine the number of Grade A Students and the feedback from the students to get an overview of the competence

FOCUS ON DELIVERY TO CUSTOMER- A SIMPLE FLOW

An organization can be viewed a system of processes and activities linked to deliver.

Delivery is one of the key characteristics of an organization.

Delivery is defined as an activity to satisfy (meet) a requirement

An organization links its activities to deliver a product or service either internally or external to it

Delivery is the sum total of the efforts of people, carrying out processes with the resources provided by a leadership which ensures that both the internal and external requirements are met.

Since resources of any nature- be it money, people, equipment, and knowledge are limited, the various elements of delivery are to be optimized

Optimization is dynamic in nature and needs continual review

Hence any delivery process works efficiently and effectively under controlled conditions

One of the controlled conditions is a system approach

Since system approach is standardized, ISO 9001 provides a platform to conceptualize and implement this with ease and consistently

The basic elements of a system approach in an organization to be deployed to ensure delivery are

Leadership, Process concerns, Customer concerns, Quality concerns, HR concerns, Infrastructure concerns, Outsourcing concerns, etc.,

While everyone agrees that the Leadership is the core element, the rest of the elements are bound and linked to ensure consistency

MOST COMMON NCR's

Document related

·         Uncontrolled documents in the manufacturing floor- including illegibility, scribbling and mutilations

·         Procedure does not reflect the practice and vice versa.

• Vendor base not being consistently updated with current revisions of drawings and documentation.
• Current and Obsolete drawings being used simultaneously
• Approved vendor list not updated regularly.
• Critical process instructions not available at the place of use.
• Instructions displayed in workplace found not under document control.
• Unauthorised and undated hand-written changes made to procedure
• Inconsistency in the revision status of same document at different places of use

 Product related

• No clear identification of good and non conforming material.
• Incorrect storage of materials.
• Shelf life products not assessed periodically
•  Over aged product in storage

·         Management related

• Internal quality audits not carried out at specified intervals.
• Actions minuted in the management review committee meetings  not followed up for
• completion.
• Product non-conformances at in-process stage not selected for corrective actions.
• Internal quality auditors carrying out audits without formal training

·        Records related

• Quality record  not legible
• Improper indexing /storing of records

Solutions to the above lie in the following

• Design simple and operable management systems- adopt KISS- Keep It Simple and Short
• Bring in all the documents under management system purview- never have any procedure/template outside the system
• Assign process owners and make them accountable for the process performance
• Make the system user-friendly and comprehensive
• Create, store and retrieve documents and record using soft copies and avoid hard copies as much s possible
• Bring in a culture of adhering to systems by periodical training to users
•  Provide leadership in system maintenance

·        

• 
  

IA Catchwords– Series 9

Observe

Observe is an important catchword in Auditing. In fact, an experienced Auditor uses this effectively, in identifying non-compliances and incompatibilities during Auditing. Non-compliance occurs, when there is an observed gap between documents and practices and incompatibility occurs, when the auditee provides a process explanation which is different from the observed ones. In both the cases “observations” by the auditee is critical.

Given below are 10 commandments for the Auditors

1. Observe the process operations in action- conversion of inputs to outputs
2. Observe the deployed process controls for correctness and effectiveness
3. Observe the records of process monitoring for correctness and completeness- including control charts and process cards
4. Observe the workplace arrangement
5. Observe the workplace safety
6. Observe the process document dynamics- how often the process operations have been revised/improved
7. Observe the body language of the auditee to verify the process knowledge
8. Observe the comfort and confidence in the auditee’s answers
9. Observe the handling and retrieval of records maintained
10. Observe the storage & handling of process rejects

Hope you would be able to practice the above. Please share your experiences. Good Luck

QMS Data Management- Series 2

Collation of data is done using a data matrix. The next step is prioritizing the parameters towards process improvements. Prioritization is based on the criticality of parameters/processes, expectations of customers, stakeholders, etc., The next step would be to carry out data analysis.

Data analysis consists of using various statistical tools. Statistical methods help to understand processes, to bring them under control, and then to improve them.  If one is running a high-volume product process, Control Charts help in Pareto Chart and Cause-and-Effect chart are the most useful tools for others. When we are dealing with simple individual processes, the above can be applied effectively. However, in an organization where many processes are involved, it is better to deal with them at a global level, since there are multiple process owners.

Approach

A sensible and effective approach to carry out Data Analysis would be by using a Data Analysis Team (DAT) drawn for the specific purpose. The following steps are recommended.

·         As the Team Leader, Management Representative (MR) takes the initiative in forming this DAT. He selects the team members having good analytical skills and process knowledge in his/her area of work.

·         MR has to ensure that at least one member is represented by each process/function identified for improvement.

·         Brainstorming sessions would make the job easier for the MR.

·         The first step is to study the existing system, and identify potential causes of root causes and prepare a Ready Reckoner

·         The various heads under which these Root Causes are identified could be

o   Men

o   Machine

o   Measurement

o   Method/System

o   Materials

o   Documentation

·         One must realize that the various potential root causes fall under 80/20 rule- meaning that common causes are 80% and only 20% are special to an organization.

·         Some examples of potential root causes under each head are

o   Men- lack/less of communication skills, lack/less of commitment/attitude of personnel, lack of product knowledge, lack of product knowledge

o   Machine- improper machine/tools/dies/jigs setting, inadequate/improper machine maintenance, inadequate machine/equipment performance

o   Measurement- inadequate test equipment, improper recording, inadequate calibration

o   Method/system- inadequate monitoring/controlling of processes, inadequacy in operational planning, inadequate supplier control

o   Materials- improper choice of parts/components, material mix-up, alternative materials used

o   Documentation- inadequate process documentation, inadequate recording, non-availability of controlled documentation

·         Deployment of the ready-reckoner in completing the data analysis would be discussed in the next article. Meanwhile, initiate and go ahead with forming DAT. Any help, do not hesitate to contact. Good luck

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