Quality management

Set it up in your plant

Setting up Quality management in your plant. Quality management keeps what goes wrong and what is done about it: nonconformances raised on the floor and dispositioned (use as is and repair by the material review board, Quality and Engineering together), corrective and preventive actions worked as 8Ds and verified effective, customer complaints answered on time, deviation permits, and product and process changes.

1. Install itIT

   On the plant's OpenCore MES server, in its plant folder: sign in once with a licence token from your account at suites.opencoremes.com (one token per installation: production, test, training), install the suite, then restart OpenCore MES (opencore-mes start, or the service that runs it). The start log then lists it.

   opencore-mes suite login

   opencore-mes suite install quality

2. Try it on a test installation firstIT

   Install it on a test or training installation before production. There, load its sample records (Designer → From the suites → Load its sample records) and walk the Quality board, the material review board and a corrective action with the people who will use them. Samples never go on production.

3. Prepare People & departmentsAdministrator

   The suite's designs give their roles to the groups quality (decides: dispositions, corrective actions, complaints, deviations, changes), engineering (investigates root causes, assesses and carries out changes, sits on the review board), production (raises nonconformances, asks for deviations and changes) and it (reads). Check those groups exist with the right people, and that the engineering department has the people who may verify the review board's decisions beside Quality.

   • The review board's disposition, a deviation's decision and a change's decision are signed by Quality and verified by someone of Engineering, signed in beside them (the second person beside the name at the top).
4. Take its designs through a changeDesigner

   Designer → From the suites → Start a change from it. The change holds the nonconformance, corrective action, complaint, deviation permit and change request objects, the sixteen moves, the four plans (a corrective action overdue, its effectiveness check, a complaint's answer due, a deviation permit's end) and the six screens. Change what differs in your plant before submitting: the places a nonconformance is found, the categories of complaint, the dispositions your customers allow, the review board's department, the screens. Run the fitness test, submit; a reviewer passes it; each department it reaches approves it (its stewards are Quality, and Engineering for change requests).

   • Once live they are your plant's own designs: they keep working if the suite is removed.
5. Bring in what is open todayEngineering

   Enter the nonconformances, corrective actions, complaints, deviation permits and change requests still open in your old system, each in the state it has reached (the opening policies allow it), with their owners (a Person) and dates. For many at once, import them from Excel (Data → Import / export).

   • Once they are in, remove the opening policies (qms_*-opening) through a change: from then on only the moves change them, signed where they say.
6. Raise and disposition on the floorProduction

   Put the Raise a nonconformance screen at the stations (or its move on the screens operators already use): what is wrong, where it was found, how much, how bad, with a photo. Quality contains it, then dispositions it: scrap, rework, return to the vendor or regrade alone (signed); use as is or repair on the Material review board screen, with Engineering beside them. A critical nonconformance is never used as is or repaired, and closes only with its corrective action; a major one with one, or saying why none is needed.

7. Work corrective actions as 8DsQuality

   Open a corrective action from a nonconformance, a complaint, an audit or a trend, with its owner and due date; the owner's team records the root cause and how it was found, the actions chosen, then the actions done and what keeps it from coming back elsewhere, with the date to check it worked. On that date Quality is asked to verify it: effective, with its evidence (closed), or not (investigated again). A corrective action past its due date asks Quality to chase it.

8. Answer customers, permit and changeQuality

   Log each complaint with its answer date (Quality is asked when it comes unanswered), mark whether it must be reported to an authority, and answer it signed. Deviations are asked for before the work and expire on their last day by themselves. Changes are asked for by anyone, assessed by Engineering (risk, validation needed, customer told, effective date), decided by Quality and carried out with the validation report where one is needed.

9. Go liveQuality

   Train the floor on raising a nonconformance, Quality and Engineering on the review board and the 8D; review the Quality board (open items, by where found and how bad, the cost of nonconformance) in your weekly quality meeting.

The same guide is in FLAMES once the suite is installed: Designer, From the suites, Set-up guide.