CHAPTER 5

Process Analysis Against a Checklist of Process Requirements to be Met

Do not find fault—find a remedy

– Henry Ford

SYNOPSIS

A list of 17 requirements applicable to a manufacturing process is given. A number of issues that need to be examined under each requirement are listed. If these are examined, then defects and their sources can be identified and measures to plug the defects at their source are possible.

Background

Every process, no matter what its nature, has to deliver product, service and/or information as per specified stipulations. To accomplish this objective, each process must operate according to certain requirements. A knowledge of these requirements is a must. It helps to assess the process deficiencies and take suitable measures to improve it.

Checklist of requirements

Process

As a rule, every process must have a checklist of the requirements it has to meet. The process flow chart helps to develop such a requirement. The method of preparing the process flow chart is dealt in Chapter 6.

Checklist on process requirement is a dynamic document and must be updated from time to time.

Illustration

A generalised list of requirements for a manufacturing operation addresses several issues of the process as mentioned in Table 5.1.

TABLE 5.1 Requirements: Manufacturing Process

Ref. Requirements
A Housekeeping
B Infrastructure
C Measurement devices
D Calibration
E Visual control
F Defect prevention
G Material input
H Specific uses
I Process interferences
J Personal ware
K Laboratory link
L Process parameters
M Product parameters
N Process defects prevention
P Maintenance
Q Sensory standards
R Work instructions

Requirements stated in Table 5.1 are illustrative but not exhaustive. For each requirement, a number of questions are constructed and these questions are used while screening/ reviewing the process. Annexure 5A gives the questions list.

Screening/review of process

A process, with which a continual improvement project/problem is associated, is subjected to screening/reviewing that takes place at the place of the process. All concerned with the process, including ‘operators’, are involved in the exercise. Data associated with the process, observations and crosschecks made are used in finding the process deficiencies. These form the basis of planning suitable actions to tie up the loose ends that deficiencies reflect. The effectiveness of the action is also evaluated. The actions found effective are incorporated in the process documents to ensure their routine adoption. Thus, a process analysis carried out with reference to requirements set out as a checklist enables to identify the deficiencies/deviations that need to be set right and thus improve the process.

The checklist and screening/review are illustrated with respect to manufacturing process. Similar approach holds good for any process provided a review checklist, in the pattern shown in Annexure 5A, is prepared for the relevant process.

Conclusion

A checklist of requirements of a process is another key-information document like the SIPOC diagram. This checklist is a live document that has to be kept updated as and when found necessary, but reviewed compulsorily once-a-year and controlled through version number and date.

Annexure 5A

Process Audit Checklist
Revision no.: Date:
Name of the process:   Process owner:
Process associates:
Date of audit: Auditor: Audited by:
Aspect and check points Observation (points, omitted if any need to be recorded and checklist should be updated)
(A) Housekeeping
  1. Is it neat, clean, orderly?
  2. Evidence, regular, scrap removal
  3. Item without identification—type and acceptance status
  4. Is there specific place for OK, rework, reject, scrap?
  5. Age of WIP
  6. ‘Good’ and ‘Bad’ mix-up possibility
(B) Infrastructure
  1. Lighting
  2. Ventilation
  3. Exhaust arrangement
  4. Floor condition
  5. Safety arrangements
  6. Fire safety
(C) Measurement devices
  1. Number of on-line instruments that are working
  2. Number of on-line instruments that are not working
  3. Number of on-line instruments kept out of use though in working condition and the reasons for each such case
  4. Number of new instruments that need to be adopted and justification for each such case
    1. Has it been installed?
    2. How much is being met?
    3. How much to be met and when will it be met?
(D) Calibration
  1. Is everyone with its unique identification?
  2. Is everyone with its “Cal-OK” identification?
  3. Date due for calibration
    1. Known
    2. Complied
(E) Visual control Parameters to judge the efficiency of the process
  1. Have they been identified?
  2. Has the database been specified for each?
  3. Have the parameters been displayed?—Each one
  4. Does every employee understand and realise his/her actions to improve the performance?
  5. Is display up-to-date?
  6. Is any parameter missing/needs to be added?
(F) Defect prevention
  1. What on-line measures are available?
    (their details with device and defects prevented)
  2. Is each in working condition?
  3. Does each operator know
    1. their purpose?
    2. how they perform?
    3. when they are not performing and what to do?
(G) Material input Does everyone know
  1. how, where and when the materials come to process?
  2. how to link the material with its mode of processing and all the associated details such as drawing, tools, jigs and fixture?
  3. how to find answers in case of doubt/clarification?
(H) Specific uses Does everyone
  1. know the meaning of critical, reusable, expiry and shelf-life item?
  2. know the list of items covered in each of those four categories?
  3. know the material acceptance rule to be followed at the process for each category?
(I) Process interferences
  1. Does everyone?
    1. Does everyone know the list of interferences that affects the process?
    2. know the specific action to be taken immediately as per the tolerance for the process and in-line product subjected to interference?
    3. know where to record the details of the action taken?
  2. Are such records available?
(J) Personal protection equipment (PPE)
  1. Does everyone know the personal protection equipment one has to have at the process such as head gear, gloves, apron and footwear?
  2. Is there a display of the list?
  3. Does one know the need to improve the work?
  4. Is work discipline adhered to?
(K) Laboratory link
  1. On what parameters of process on-line control is linked to laboratory analysis. Is a list available?
  2. Are instructions clear about the type of samples to be taken—time frequency, location, sample specific to a location or corporate covering the locations?
  3. Do guidelines on type of process adjustments to be made correspond to the laboratory analysis results specified for each process parameter?
  4. Is data on purity, concentration of chemicals available? Are these informations used to calculate the quantity to be added to the process?
  5. Verify the knowledge of each concerned process associated on each of the earlier points.
(L) Process parameters
  1. How many parameters are there?
  2. How many are measured, monitored and acted upon
    1. on-line
    2. off-line
  3. How many are not subjected to control?
  4. What action plan on (3)?
(M) Product parameters
  1. How many parameters are there?
  2. How many are measured, monitored and acted upon
    1. on-line
    2. off-line
  3. How many are not subjected to control?
  4. What action plan on (3)?
(N) Process defects prevention
  1. What are the defects occurring during the process—Is list available?
  2. Which ones are detected at the process? How?
    Does it detect 100%? How effective is detection?
  3. Which one affects customers
    1. internal and external defects
    2. seriousness of each defect
  4. Measures to prevent and detect defects in (3):
    1. mistake-proofing possible at the process
    2. fool-proofing inspection and testing for efficient detection
(P) Maintenance
  1. Is there a preventive maintenance schedule?
  2. Is it adhered to?
  3. Is there evidence of updating it to utilise the latest experience/knowledge?
  4. Is there any plan to upgrade the machine to improve its capability?
(Q) Sensory standards
  1. Is there a list of sensory standards applicable at the process?
  2. Has a reference standard been specified for each sensory characteristic?
  3. Are sensory standards available at the place of use?
  4. Are they kept updated?
(R) Work instructions (WI)
  1. Is flow chart method of WI adopted instead of verbal version?
  2. Does everyone understand and interpret a flow chart?
  3. Are the following on display:
    1. Rules and precautions for start and stop
    2. Lubrication points
    3. Check-ups before start and closure
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