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CAPA Operating Procedure - Flow Chart or Written Out?

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Pancho

Pancho

wikineer
Super Moderator
#12
#12
MNCountry said:
...or have it written out (of which I have not found any YET)?
Click to expand...
Here is an excerpt of our "Continuous Improvement" procedure. It guides us in handling both CAs and PAs. Links to other documents in our system are in green. Unfortunately, the 3rd and lower level alpha bullets get converted to numbers when copy-pasting, but I hope the indentation allows it to still be readable and useful.

Good luck!
Pancho

==============================

[SP: Continuous Improvement]

a. Objective

Systematically and continously improve our management systems and processes. Take corrective action to prevent recurrence of non-conformities or ocurrence of potential non-conformities.

b. Scope and Definitions

  1. Scope: This procedure describes how to request corrective and preventive action, how to generate these actions, and how to improve continuously our systems.
  2. Definitions:
    1. Non-conformity (NC)...
    2. Correction...
    3. Containment...
    4. Root Cause (RC)...
    5. Corrective Action and Preventive Action (CA)...
    6. Request for Corrective Action (RCA)...
c. Owner

Quality Manager

d. Procedure

  1. Handling of NCs: Non-conformities shall be corrected and contained as soon as possible after detection. It is not necessary to file a RCA before correcting a NC. Upon detection of a NC,
    1. Correct and Contain:
      1. Product NCs shall be corrected and contained following SP: Handling of Product NC, registered in RE: Rejects. Every two weeks, the Quality Manager reviews the RE: Rejects logs and reports and opens RCAs following the WI: Pareto selection of NCs.
      2. Service and Documentation NCs shall be corrected and contained in the manner necessary to meet our client and regulatory commitments. This may include redoing the NC work, or soliciting a waiver if that is not possible. The correction and containment actions are recorded following this procedure.
    2. Initial evaluation -- Evaluate whether the NC affects the quality of our delivery and is recurrent, or whether it creates an unsafe condition.
      1. If the NC will not recur or if the NC does not affect the quality of our delivery; and if the NC does not create a hazardous or unsafe condition, then it is not necessary to Request Corrective Action by opening a RCA. In this case terminate this procedure after Correction and Containment.
      2. If the NC will recur and affects the quality of our delivery; or it creates a hazardous condition; or if you are not sure whether the NC has these characteristics, then continue with the Search as follows.
    3. Search. Before opening a RCA, search in the RCA database for similar prior requests. See IT: RCAs quick guide.
      1. If an RCA exists for your NC, then:
        • add the data from your new instance to the existing RCA. Do not open a new RCA.
        • If CA has been taken, but recurrence was not averted, then the CA was not effective. Reopen the RCA and terminate the execution of this procedure.
      2. If no existing similar RCA is found, then open a new RCA as follows.
  2. Request Corrective Action Click "new" in the RCA database and Fill out the following fields:
    1. Process
    2. Type: Select from (client_complaint, internal_complaint, input_NC, audit_NC, hazard, preventive).
    3. System Document: Link to the document that describes the procedure or activity where the NC arose.
    4. Description: Describe the NC in detail. Link to the project, audit and other relevant wiki pages.
    5. Correction and Containment: taken, if known.
    6. Attachments and Illustrations: If possible, illustrate the NC with photos, records, and other attachments that help understand the problem.
    7. Links to relevant records: For example, rejection record or injury report.
    8. Comments: If possible include your own comments or observations regarding possible RCs or ACs required.
  3. Assignment: After opening the RCA,
    1. Notice: the database sends email autamatically to a default list of persons involved in the process where the NC occurs, and assigns the process owner as responsible for analyzing and determining the appropriate CA. The person that requires the CA may change the default assignment with the approval of his or her supervisor.
    2. Re-assignment: The assignee may, with the approval of his supervisor or a member of the Management Comittee, reassign the RCA to another more suitable person.
    3. Supplier RCAs: RCAs of type "input_NC" are assigned to the Quality Manager. He shall request the corrective action from our supplier, follow until satisfactory action is taken, and document it in the RCA record.
  4. Analysis: As assignee, analyze the NC as follows:
    1. Corretion and Containment: Describe what was done to correct and contain the NC, if not already noted.
    2. Second Evaluation:
      1. If the RCA has been reopened, or you judge that the NC can recur and is relevant to our quailty delivery, or poses a hazard, then proceed with the analysis.
      2. Conversely, if the RCA has not been reopened, and in your judgement the NC will not recur or its effect on our quality delivery is negligible, and it does not pose a hazard, then explain your reasoning and conclusion in a comment, set the status field to resolved, and the resolution to "WONTFIX". In this case it is not necessary to take further analysis nor CA.
    3. Resolution periods:
      1. For the following type of NCs, analysis shall be complete and CA must be taken as soon as possible and always within one month from the request:
        1. Client complaints
        2. Audit NCs
        3. Hazards
      2. For NCs of other types, analysis shall be complete and CA shall be taken within 3 months from the request.
      3. If the resolution period cannot be met, then the assignee shall explain, in a detailed comment and before the original period expires, how long it will take to complete the analysis and CA, and how NCs are being corrected and contained in the interim period.
    4. Discussion: Persons that received copy of the RCA can submit their observations, comments or analyses to the database at any time. Comments shall be towards the determination of the Root Cause and AC. Avoid off-topic comments or jokes. The writer shall avoid giving offense and readers shall avoid taking offense.
    5. Root Cause (RC):
      1. The assignee shall describe his analysis to determine the RC in one or more comments. The analysis may be by "5 whys", Ishikawa diagram, or any other rational method. See Course on Root cause determination.
      2. Fill out the Root Cause field.
  5. Corrective Action: The assignee shall determine the corrective action that will prevent the occurrence or recurrence of the NC, and then implement it.
    1. Possibles actions:
      1. Modify the process and its documentation (equipment, layout, procedure, instructions, software or other characteristic of the process).
      2. Train or re-train personnel that does the work, along with
        1. 5 whys if not already used.
        2. If retraining is part of the CA, explanation of why earlier training was unsuccessful.
        3. Evidence of the training, such as a filled FO: attendance with a description of the training.
      3. If the CA involves or is taken by a supplier, evidence of the implementation must be scanned as an attachment.
      4. If a desirable corrective action involves more resources than available to the assignee, he or she may start an Improvement Project as described further below.
    2. Link to document: If not already done, fill out the URL field with the link to the system document that describes the activity where the Root Cause was found and eliminated.
    3. Status and Resolution: After the Corrective Action is determined and its implementation started, the assignee sumarizes the action in the corresponding field of the RCA database, writes the detail in a comment, updates the status to "RESOLVED" and the resolution to "FIXED".
    4. Review and Closure: The QM or the Management Representative or the CEO reviews and evaluates the effectiveness of ACs with "RESOLVED" status at least once a month, and judges whether to set the status to "Closed" (if the CA was effective) or to "Reopened" (if the CA was ineffective or if the documentation is incomplete).
  6. Improvement Projects: When one or more related RCAs cannot be resolved with the resources that their assignees control, then such RCAs shall be registered as Improvement Project RE: Improvement Projects. The CA is "Open improvement project", a wiki page for the project is opened, and a link to the project page is noted in a comment. Improvement projects shall have the following information in their wiki page:
    1. Owner
    2. Scope
    3. Personnel assigned
    4. Budget
    5. Schedule
    6. Completion date
  7. Management Review: Open RCAs ("Unresolved" report), new CAs ("Resolved" report), and RE: Improvement Projects are reviewed by management following SP: Management Review.
 
J

JaneB

#13
#13
DrM2u said:
Recent versions of MSWord have a decent flowcharting tool.
Click to expand...
:confused: Your idea of a 'decent flowcharting tool' and mine are clearly very different. Word can do VERY funny things with things produced in its flowcharting app - I think it's a complete waste of time using it and will use virtually anything else in preference.
 
D

DrM2u

#14
#14
JaneB said:
:confused: Your idea of a 'decent flowcharting tool' and mine are clearly very different. Word can do VERY funny things with things produced in its flowcharting app - I think it's a complete waste of time using it and will use virtually anything else in preference.
Click to expand...
I consider MSWord decent enough for a small organization that cannot aford to spend much money for better flowcharting softeware. Indeed, Word does funny things depending how the Draw features are used (auto connectors, moving, editing, etc). Of course, there are other low-end software packages but the ability to integrate and link a flowchart to a text document can become a problem. For my own use, MSWord is nowhere near 'decent' but I also have to consider my clients' resources and abilities. :)
 
J

JaneB

#15
#15
DrM2u said:
For my own use, MSWord is nowhere near 'decent' but I also have to consider my clients' resources and abilities. :)
Click to expand...
Me too. My comments stand, and have already taken this into account.

Better by far to use PowerPoint, and then paste the result into Word (but as a graphic) than to use Word itself.
 
J

jhoniegudel

#16
#16
We used both of them. Describe the process with flow chart and added some note with written out.


jhonie
 
M

MNCountry

#17
#17
Many thanks to everyone for your opinions and suggestions :agree1: It is very encouraging!
I am going to go with a combo of flow chart and written out.
 
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